https://biospectrumindia.com/rssfeed/bio-interactions/premium%20article premium article https://biospectrumindia.com/views/82/20809/our-focus-is-to-accelerate-biomarker-research-to-enable-better-disease-understanding-and-effective-interventions.html https://biospectrumindia.com/views/82/20809/our-focus-is-to-accelerate-biomarker-research-to-enable-better-disease-understanding-and-effective-interventions.html Thu, 03 Mar 2022 12:40:00 +0530 How will the Indian biopharma market evolve along with the surge of cutting-edge technologies in terms of precision medicine?   Dr Yadav: In the future, a key initiative should be to develop a world-class pharmaceutical plant with cutting-edge machines that manufacture products at high speed with precision and reliability that is consummate with quality and compliance standards. This will help accelerate indigenous vaccine research in India. The newer technologies to be developed include multiplex immunoassay which enables the detection of as many analytes as possible in a single assay, all in all, to reduce the overall number of assays, as a way forward towards this step.     How can multiplex immunoassays support the development and clinical trials for vaccine and drug development efforts?    Dr Yadav: Finding novel ways to use technologies that have been previously proven to work in vaccine development is one way to further speed up. In vaccine development, safety and efficacy are critical. Recent studies have shown that multiplex immunoassays offer a flexible way to monitor immune responses. The process of screening is necessary to ensure that only the best candidates are selected for further testing, but can be time-consuming and resource-intensive. Multiplex immunoassays have been used throughout the vaccine research process to expedite screening. Requiring only small amounts of a clinical sample, multiplex immunoassays can be applied at all stages of vaccine/drug development, including at the preclinical stage, and is a proven tool to monitor critical safety and efficacy of the process. Specifically, it helps in the precise understanding of the immune status in terms of pathogen-specific cytokine and antibody profile of the study participants.       With the increasing need for multiplexing biomarker analysis, how does Merck enable access to these new technologies for the scientific community?    Dr Joshi: "Prevention is better than cure" is an excellent metaphor for biomarker research. Multiplex immunoassays help speed up disease research and biomarker discovery. We can help the scientific community to acquire data that they can trust out of each sample, with little repetition to make the best next-step decisions. Whether one needs an ultrasensitive detection from an SMC assay, robust ELISAs, or rich multiplex profiling data using MILLIPLEX and Luminex xMAP technologies, we pioneer in bringing the best solutions to enable scientific research in the life science space. Merck has created two labs to enable easier access to these state-of-the-art technologies: the Merck Innovation Lab and the High-End Skill Development Lab. Both our labs are equipped with cutting-edge technologies like the Luminex systems, SMCxPRO for ultra-high immunoassays, SNAP i.d 2.0 Protein Detection System, and the Auto2D Automated 2-D Gel Electrophoresis Device. From antibodies to enzymes to small bioactive molecules and custom services, we have the solutions you need for any biomarker analysis.     How multiplex immunoassay contributes to serotyping and sero-surveillance studies?   Dr Yadav: Serological data indicating the presence and level of antibodies against infectious disease antigens provide indicators of exposure and transmission patterns in a population. Laboratory testing for large-scale serosurveys is often hindered by time-consuming immunoassays that employ multiple tandem steps. Serosurveillance is increasingly becoming an attractive and economical strategy for multiple disease-specific public health programmes in the hope to gather information within a population regarding pathogen exposure or vaccination coverage. The use of bead-based multiplex immunoassay technology has been gaining recognition as a next-generation screening tool in seroprevalence studies with high-throughput and timely collection of antibody data. Bead-based multiplex immunoassays contribute to serotyping and sero-surveillance studies through simultaneous detection of multiple pathogen-specific antibody responses in a small volume (25ul or 50 ul) of serum/plasma or other clinical samples. It also has the advantage of investigating a large number of clinical samples in a high-throughput manner in a short period of time.     How does Merck support the vaccine development process, specifically in bringing the candidates to market?    Dr Joshi: During the development of vaccine candidates, biomarkers can help anticipate adverse events. Understanding vaccination effectiveness and safety are critical during clinical trials. To find clinically useful biomarkers, patients must be stratified to find the best prospects. Merck's MILLIPLEX biomarker screening assays detect over 1,300 soluble analytes across 11 species, making it the most comprehensive in the industry, including the NHP (non-human primate) panels to aid the COVID-19 vaccine developments.    A diverse portfolio facilitates the transition from animal models to clinical research. Along with multiplex immunoassay solutions, our Single-Molecule Counting-based SMCxPRO can aid in the stratification of clinical trial participants and gain insights into vaccine candidate efficacy. Our MILLIPLEX assays aid the detection and exploration of biomarkers, whilst SMCxPRO enables the detection of minute yet critical changes in the level of the biomarker.         How will the newly introduced xMAP INTELLIFLEX system support the acceleration of research?   Dr Joshi: The Luminex xMAP INTELLIFLEX system, was introduced with our goal of providing the finest solutions for novel biomarker research. The system includes an integrated touch screen with updated software and comes in two configurations. A high-throughput RUO version with all the advantages of bead-based multiplexing, as well as a second variant (DRSE) with a dual reporter and side eject variation that is more suited for automation. The dual reporter channel increases the number of data points acquired from a single sample, which improves efficiency. With access to progressive tools, services and expertise, we are proud to be partners of researchers in their scientific breakthroughs, solving the toughest problems in life science.     ]]> https://biospectrumindia.com/features/82/18869/build-a-tech-driven-career-in-healthcare-with-pharmaceutical-management-at-nmims-.html https://biospectrumindia.com/features/82/18869/build-a-tech-driven-career-in-healthcare-with-pharmaceutical-management-at-nmims-.html Tue, 08 Jun 2021 16:00:00 +0530 The Indian pharmaceutical industry has emerged as the dominant force in the global marketplace in the last decade. As the world’s largest manufacturer of generic drugs, it supplies over 50 percent of global demand, providing critical vaccines and medicines across the world. It also produces pharmaceutical scientists who are leading innovations and improving the quality of healthcare services. As per the Economic Survey 2020-21, the domestic pharma sector is expected to triple in size over the coming decade, to reach $120-130 billion by 2030 from the current estimate of $41 billion in 2021[1]. Sizable investments in research & development and manufacturing are also fuelling a robust increase in employment opportunities. Despite its remarkable growth, the Indian pharmaceutical industry is not without its challenges. The past one year has not only highlighted the vast gap in the country’s public healthcare infrastructure, but has also demonstrated the tremendous potential of technology in bridging it. Pharmaceutical managers are critical to lead expanding opportunities in corporate R&D, retail, sales & marketing, analytics, and supply chain. They are also required to spearhead the more administrative and academic requirements in clinical research, policy and regulations. Now, with the increasing application of new and emerging technology in the industry, and the scope of data-driven public healthcare, there is a greater requirement for managers with the ability to harness technology in tandem with their domain expertise, manage cross-cultural teams, and drive strategic organisational growth.   The NMIMS Advantage NMIMS Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management (SPPSPTM) in Mumbai, and School of Pharmacy & Technology Management (SPTM) in Shirpur and Hyderabad, offer several programs to meet this growing demand for healthcare-managers in the pharma industry. Since the launch of Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management (SPPSPTM) in 2006, followed by School of Pharmacy & Technology Management (SPTM), under the aegis of SVKM’s NMIMS Deemed-to-be-University, the schools have been pioneers in the field of pharmacy management in India, known for their holistic education that grooms industry-ready graduates. With AICTE-approved programs, the schools are known for their state-of-the-art campuses at Mumbai, Shirpur and Hyderabad, and a continuously-updated curriculum that is responsive to industry needs. The schools have also received recognition for excellence in learning, with SPPSPTM being adjudged Best Educational Institute in Pharmacy by World Education Congress Global Awards, and Best Institute of Pharmacy by DNA and Star Group, and SPTM, Shirpur, being chosen for the Innovative Education Award by DNA & Star Group. Since their inception, SPPSPTM and SPTM have created significant inroads into the pharma industry. With a well-established and deep industry network, they are among the few pharma schools in India that offer students hands-on experience in the field with Capstone projects, industrial training, and internships. The focus is on developing a practical approach that is cognisant of on-ground realities.   Integrated B. Pharm. + MBA (Pharm. Tech.) The five-year, dual-degree B. Pharm. + MBA (Pharma. Tech.) is a customised, industry-relevant program for students who wish to pursue a rewarding career in pharmacy, providing them with management expertise as well as technical knowledge of the pharmacy domain. Successful candidates are awarded with both B. Pharm and MBA degrees in Pharmaceutical Technology at the end of the program. Apply now.   Integrated M. Pharm. + MBA (Pharma. Tech. & Healthcare Management) This is a three-year, dual-degree program which equips students with managerial dexterities as well as advanced research skills, to produce healthcare-managers capable of leading the industry through cutting-edge innovation. In addition to an MBA, successful candidates also receive an M. Pharm. degree with specialisation in Pharmaceutics, Pharmaceutical Quality Assurance, Industrial Pharmacy or Pharmaceutical Technology. Both Integrated B. Pharm. + MBA (Pharm. Tech.) and Integrated M. Pharm. + MBA (Pharma. Tech. & Healthcare Management) allow aspirants to save one year and forego the stress of appearing for B-School entrance examinations. In addition to the integrated programs, NMIMS also offers programs for D. Pharm., B. Pharm., M. Pharm., and Ph.D. The two-year D. Pharm. program, designed in accordance with Pharmacy Council of India regulations, trains students for hospital and community pharmacy roles, while the four-year, PCI-approved B. Pharm program prepares graduates with a keen focus on healthcare, through practice and expert interaction. The two-year M. Pharm program provides further technical domain knowledge through specialisations in Pharmaceutics, Pharmaceutical Quality Assurance, Industrial Pharmacy and Pharmaceutical Technology. Through the Ph.D. program, NMIMS nurtures the development of world-class researchers and academicians who possess the critical and analytical thinking necessary to pioneer innovation in the industry.   Career Prospects With its all-around grooming and academic rigour, NMIMS ensures that the graduates are industry-ready. SPPSPTM and SPTM have highly-active placement cells with a strong network across various verticals, including FMCG, market research, medical devices, pharmaceuticals & healthcare, consulting companies, health insurance, hospitals, and clinical research organisations. The Schools also have a strong connect with alumni who are working in diverse career roles, such as business analysts, marketing & sales managers, pharmacovigilance professionals, quality assurance officers, researchers, clinical data managers, medical writers, and formulation scientists. Other emerging areas in this field include novel drug delivery systems, pharmacological research & evaluation, computer-aided drug design, analytical method development, and phytochemicals. To build a successful career in the fast-developing pharmaceutical industry, aspirants today need a holistic education that combines managerial training with pharma-tech domain knowledge. NMIMS grooms skilled healthcare professionals who have the ability and the skill to take on the emerging challenges of a highly competitive global market.   To know more, please visit https://pharmacy.nmims.edu/.   [1] https://www.ibef.org/industry/pharmaceutical-india.aspx ]]> https://biospectrumindia.com/interviews/82/18201/womens-day-special-dr-priti-v-warke.html https://biospectrumindia.com/interviews/82/18201/womens-day-special-dr-priti-v-warke.html Wed, 03 Mar 2021 17:50:00 +0530 Women worldwide make up for less than 33 per cent of researchers, says a UNESCO Science report. With India lining up for becoming the next hub of bioscience research, its women leaders are already making their mark on the global reach ecosystem. Having said that, there can’t be a more suitable time to recognise their contributions. One such exceptional leader is, Dr Priti V Warke, Director, Cell Culture & Plant Tissue Culture businesses, HiMedia Laboratories. She also heads the Regulatory Affairs. Being a leader, assuming multitude of roles comes naturally to her and she keeps excelling in each one with equal zest and spur. Starting her career as an Assistant Scientist in Himedia, Dr Warke has, risen to the levels of director taking one step at a time, and has very effectively maintained a healthy work life balance. She moves towards her goal to make a difference in lives of people through the use of science & technology, thus keeping her humane side alive. Dr Warke has been actively involved in R&D, operational and administrative activities of the Cell Culture business. She has been instrumental in starting the stem cell and regenerative medicine division in HiMedia. Presently, she is actively involved in developing serum free media, assay kits, cells required for manufacturing of monoclonal antibodies for cancer and COVID-19 detection kits. Apart from handling the business hum-drums, Dr Warke is an avid yoga practitioner and guides people through yoga, helping them enhance immunity. Her journey is, most certainly, inspiring for many women today. As we celebrate Women’s Day on March 8, BioSpectrum reached out to Dr Warke to find out more about her experience in 2020 while fighting the pandemic-   What have been your key contributions within the organisation towards fighting COVID-19? At the outset, I would stress on the fact that tackling the pandemic and lockdown was more teamwork than an individual feat. However, my role in making decisions to arrange human resources, logistics, investments and roll out of the products into the market via right channels was crucial. Our principle product during this pandemic was the Viral Transport Media, a mandatory sample collection kit. The number of VTM units manufactured till the end of 2019 did not cross 500 thousand test units per year, as opposed to the requisite of one million test units per day during the pandemic.  The challenge was to make a decision pertaining to mass production and supply of VTM double time since HiMedia was the only supplier of VTM during the initial months, thus, leaving no scope for delays. I jumped in and immersed myself into working 24/7, focusing on ramping up the production process and within 15 days, we increased the production capacity to one million test units per day. Today, I can say that, in the past many months, HiMedia was able to provide over 20 million VTM tests for diagnosis of COVID-19. Additionally, in collaboration with Syngene, we have successfully developed ELISafe 19 TM – an antibody based ELISA kit for COVID and also developed COVIDSafe, a Virus Inactivation Transport Medium.   How have you been able to tackle the pressure created by the pandemic? I had to take an all-inclusive approach to tackle the pressure as everyone was equally concerned. We had stopped production of all other products and singularly focused on mass production of VTM, which was the need of the hour. In doing so, a proper distribution of work became easier as per expertise. We divided the work in shifts to meet the requisite production capacity. Stay, food and daily needs of workers were provided for workers staying in the production premises throughout the lockdown. Safe transport was arranged for employees. Increase in production capacity meant more need to human resources. We conducted incentive driven hiring and bulk recruitments. I made sure I attended to the mental health of employees by guiding them through yoga and providing healthy diet charts.     ]]> https://biospectrumindia.com/features/82/17772/what-it-takes-to-deliver-for-a-global-healthcare-crisis.html https://biospectrumindia.com/features/82/17772/what-it-takes-to-deliver-for-a-global-healthcare-crisis.html Mon, 14 Dec 2020 00:00:00 +0530 There are more than 150 COVID-19 vaccines currently in development and an estimated 10 billion vaccine doses eventually will be delivered around the globe. We are already at the start of this process, with the UK getting ready to roll out the first doses. These vaccines require an unbroken chain of exact temperatures - between -20 to as low as -70 degrees Celsius - from the start to the very end to remain viable. Throughout this pandemic, the logistics industry has been an essential service provider, keeping aid and packages moving. Now, at this critical juncture of global vaccine shipping, that part will take centre stage. And we are not only talking about the need for the vaccine to be delivered across nations; it’s about the entire healthcare logistics network! Even in non-pandemic times, logistical needs of the healthcare vertical are exacting and demand the best expertise and capabilities that logistics providers can offer. The efficient and speedy shipping of samples, test kits, chemicals, syringes, vials, and other elements is just as crucial. Some have hypothesized that there may even be multiple vaccine doses required to properly inoculate against the virus.  What follows next will be the mammoth task of building and managing a global supply chain that will transport vaccine doses from laboratory to the end user. Behind the scenes, logistics providers who already serve the healthcare industry are ramping up. Find out more about FedEx Healthcare shipping solutions. Healthcare logistics already operates under strict regulations and requirements for shipping and storing of medical-grade products. On vaccine shipping alone, logistics to support this require teams of pharma experts who understand the complexity that comes with the intent of transporting billions of vaccines across continents.   A consistent cold chain will safeguard delicate shipments Vaccines - and items like medical devices, clinical trial samples or temperature sensitive pharmaceutical ingredients – often need to be well insulated and kept at super cold temperatures, typically 2 to 5 degrees Celsius. This presents the logistical risk of spoilage if temperature variations occur – even for a brief period of time. A World Health Organization (WHO) study estimates that up to 50% of vaccines, costing upwards of $1.5 million USD are wasted globally each year, largely due to lack of temperature control and the logistics to support an unbroken cold chain. Temperature-control capabilities are must-haves throughout the shipping, storage and delivery process. Cold chain facilities not only house temperature-sensitive shipments with real-time monitoring of temperature, humidity, and CO2 but also act as buffer for unexpected delays such as inclement weather[1]. These facilities offer the ability to segregate between healthcare products and other perishable commodities, and cross dock for fast unloading of cold shipments directly to cold storage[2]. Having a network of these facilities around the world – such as the 90 facilities that FedEx has in its global network – can help better tackle every contingency scenario. The increased capability to transport dry ice aboard cargo aircraft will also be key for successful vaccine delivery. As a dangerous good/hazardous material, dry ice requires special handling. Tapping into expertise from logistics companies can help healthcare companies ship, package and transport dry ice. FedEx, for example, transports approximately 500,000 dry ice shipments a month between more than 100 countries worldwide, to move critical healthcare shipments like vaccines, pharmaceutical ingredients and clinical trial bio samples. Beyond this, the company has been moving healthcare shipments to over 220 countries and territories for decades. It is important to incorporate data management solutions to understand how to extend logistical services into rural or remote communities. Real-time sensor-based technology can help healthcare customers monitor a shipment’s current location, precise temperature, relative humidity, barometric pressure readings, light exposure and shock events through near real-time updates. With these features, healthcare customers are never out-of-touch with their shipments. Click here to read more about FedEx sensor-based tracking technology.     Transportation and logistics expertise will make or break healthcare sector growth   For healthcare shipping including vaccine distribution to be a success, it is important to lean on the expertise of logistics players who are well versed in shipping for this sector. Companies with a robust team and network who have successfully transported, stored and handled shipments for clinical trials and vaccines – such as for the seasonal flu or H1N1 – globally are the ones best placed to support what will be the largest vaccination program in human history. From the beginning of this pandemic, FedEx has utilized its healthcare logistics capabilities to distribute essential and life-saving equipment critical to COVID-19 relief including ventilators, PPE, testing equipment and essential medical supplies. Having served the healthcare vertical in Asia Pacific for over two decades, the FedEx network – with its temperature-control solutions, real-time monitoring capabilities and a dedicated healthcare team of experts – is well positioned to continue serving healthcare companies. With one of the largest cargo fleet of airplanes, the company has charter flights, refrigerator trucks and trailers, warehousing, and temperature-controlled containers, to help safely move temperature sensitive shipments, such as vaccines and other bioscience shipments, around the world. Success with human and economic cost in mind  Still, we’re confident but cautious, and certainly under no misapprehension of the scale of the challenge that we’ll face once vaccines are available. By working together across government, logistics, pharmaceutical and healthcare industries – we can all move cohesively toward the common goal: overcoming this global health crisis. With the right coordination and resources, on top of our massive network and deep vaccine distribution experience, we are more than ready to take on the challenge.  A COVID-19 vaccine promises to aid economic recovery and rebuild societies globally. It’s important to keep focus on the why as well as the how: we want to contribute not only to global economic recovery, but also seek near-term benefits for struggling communities and societies across Asia and worldwide. Our mandate is clear in this fight – and we are ready to deliver.   Get in touch.   [1] http://www.fedex.com/us/healthcare/product-integrity/temperature-control/cold-chain-center.html [2] http://www.fedex.com/us/healthcare/product-integrity/temperature-control/cold-chain-center.html ]]> https://biospectrumindia.com/features/82/17542/filter-and-sensor-sets-for-single-use-filtration-in-pharmaceutical-industry.html https://biospectrumindia.com/features/82/17542/filter-and-sensor-sets-for-single-use-filtration-in-pharmaceutical-industry.html Thu, 05 Nov 2020 00:00:00 +0530 Amit Khanna, Manager for Separation Technologies (Asia) Amit.khanna@sartorius.com Amit comes from a Biotechnology background and has over 13 years of experience working in the field of Separation Technologies. He handles a team of Separation Technology Experts, gives product & application trainings to internal & external customers and has publications in leading Indian Industry journals. His expertise includes filter selection, scale up trials, integrity testing, process optimization & troubleshooting filter failures.   Traditional filtration operations in pharmaceutical industry involved Stainless steel-based lines, housings and associated sensors and other hardware. A typical operation would involve water flush, steam in place and post use clean in place procedures along with pre and post batch integrity testing. This further involves validation of steaming and cleaning procedures for filters and their re-use in the process. In the last decade, manufacturers have moved towards single use of critical sterile filters and associated tubing set up in view of ever-increasing regulatory compliance on cleaning validation to prevent endotoxin or bioburden carryover. It also decreased the change over time for the campaign since no exhaustive cleaning and sterilization is required. A single-use filtration set would require sterilization & assembly of filter, tubing and end connections along with the pressure resistant cable ties. All of these components these must be maintained in stock from separate vendors and then assembled correctly for sterilization and operation. Sterilization validation of a complex assembly may be difficult.    Image 1- Filter Transfer Set Sartorius provides pre-assembled and pre-gamma-sterilized filter assemblies in double packing which is ready-to-use. This comes with 100% filter element testing, 100% visual inspection, biocompatibility according to USP 87 or 88 class VI, TSE | BSE free certification, endotoxin limits, sub visible particle limit, extractable profile documents, pre-qualified connections and ASTM transport validation. Sartorius uses Oetiker metal clamps wrapped in rubber which are more pressure resistant as compared to cable ties for securing connections. There is increased assurance of supply since a single vendor supplies all the parts in an assembly. With this, ordering and maintaining stock becomes easier. The pain of internal sterilization | cleaning validation along with the operating training for complex assembly is reduced. Assembly of sterile components traditionally requires LAF zone, which can now be eliminated. Customers can choose to configure these filter sets from a large selection of filter capsules, tubing make, tubing lengths and aseptic | sanitary connections. Another important gap (when industry shifted form stainless steel-based filter lines) was the absence of point of use pressure and flow sensors for silicone tubing. A non-product contact arrangement was required between the reusable sensor hardware and the product solution. Sartorius offers innovative solutions for sensing POU pressure and flow. A clamp on flow device which uses two pairs of ultrasound source and sensors which measure the transit time difference between two signals (upstream and downstream sensor) to determine flow velocity. No part of the sensor is in actual contact with the product. A single-use flow pipe is provided which increases the accuracy over using bendable silicone tube. The sensor comes pre-calibrated and has high accuracy for the chosen flow range and pipe ID. The signal can be displayed on the amplifier box and further connections can be made into SCADA system for capture of process data.   Image 2: BioPAT® Flow sensor is a combination of single-use flow pipe and a multi-use clamp-on   Pressure measurement in a single use arrangement is provided by combining multi use pressure transmitter with single-use pressure pipe. The silicon membrane of the pipe and the metal membrane of the transmitter get tightly connected through an integrated fixing mechanism. The pressure in the pipe bends the silicon membrane, which bends the metal membrane and the  exerted force is detected by a pressure sensor within the transmitter. An independent display for pressure or input to SCADA system can be configured at the user site.   Image 3: BioPAT® Pressure sensor is a combination of single-use pressure pipe and multi-use transmitter   There are specific needs that require special single-use assemblies for e.g PUPSIT arrangement. Sartorius enables the development of customized solutions with the support of a team of application specialists who study the process requirments and conceptualize the prototype design. The prototype is further tested and modified, if required, for final approval and supply.   Image 4: Development of customized solutions is possible   Innovative solutions from Sartorius enable the manufacturers to implement single-use filtration operation with ease, bypassing many in house requirements of validation, sterilization and assembly operations. Single-use sensor sets with pre-calibrated hardware further provides the required operating parameter monitoring and data capture at point of use without compromising the aseptic nature of the process. For further information, visit: www.sartorius.com ]]> https://biospectrumindia.com/features/82/17337/takeone-the-only-aseptic-sampling-system-of-its-kind.html https://biospectrumindia.com/features/82/17337/takeone-the-only-aseptic-sampling-system-of-its-kind.html Tue, 06 Oct 2020 00:00:00 +0530 Not all samples are equal – categorization of a sampling plan by assay type reduces costs, improves sampling results and optimizes capacity of the sampling solution. Samples are drawn throughout the entire Pharma | Biopharmaceutical process for different steps like compounding,  holding stage, cell expansion, fermentation, buffer | media preparation, purification, final fill finish etc. Fetaures and benefits: Single use – eliminates cross contamination. Pre-assembled & ready to use – saving time and increasing safety. 100% leak tested and Gamma sterilized. Available tank fittings – 25mm InGold , 1.5” and 2” TC TakeOne® Flex – sampling from single use containers. Quick and easy disconnect. No sample overflow- spring return actuator. Application driven containers – Centrifuge tubes, PETG bottles, EVA & PE bags , needle free sampling etc. Manifold availability – expand sampling capacity.   Image 1: TakeOne® Aseptic Sampling System ensures that sample and product integrity is preserved   TakeOne® -Aseptic sampling device has been engineered to take perfectly representative samples giving exact results with no risk of false-positives for each process step, thanks to its pre-assembled, sterile and closed design. It collects process fluids for analysis while protecting the process fluid from adventitious agents. Microbiological assays like bioburden and endotoxin monitoring is required to demonstarte process control to prevent a batch rejection due to loss of sterility or high bioburden and compliance of the final drug product to the limits set by regulatory agencies; the process monitoring assays ensure that critical parameters like viability, osmolality, immunoglobulin, nutrients, conductivity, pH and gas analysis are met for successful drug production. TakeOne® Aseptic sampling device is completely ready to use & have multiple, independent sampling lines which allow for collection of perfectly representative samples. Perfectly representative samples provide perfectly reliable data allowing operators to quickly react to out-of-specification results.   Image 2: Efficeint sampling with TakeOne® Aseptic Sampling System During actuation the cannula, or the needle pierces the self sealing septa that is molded to the faceplate allowing fluid to enter the sampling pathway and into the collection vessel. The design and operation of cannula diaphragm and septa ensure a closed pathway before, during and after actuation. Once the sample has been collected operators easily cut the aluminum collar with a hand held cutting tool aseptically disconnecting the tubing and the sampling container.   Image 3: TakeOne® Aseptic Sampling System allows for point of use configuration   For further information, visit: www.sartorius.com   Authors       Niveditha Shetty Application specialist | Fluid Management Technologies Niveditha.Shetty@Sartorius.com Niveditha has a master’s degree in biotechnology from Bangalore University and close to a decade of experience in biopharmaceutical industry focusing on the single use applications. Niveditha has had a successful tenure at Pall Corporation and Saint Gobain before her current assignment at Sartorius.     Kiran Bhatambarekar Application specialist | Fluid Management Technologies Kiran.Bhatambarekar@Sartorius.com Kiran is a microbiologist by training and has ten years of experience working in the Biopharmaceutical industry He is now involved in establishing Sartorius’ Fluid Management product portfolio in the Indian Pharma & Biopharmaceutical market. Kiran’s expertise lies in end to end single-use solutions, upstream solutions & troubleshooting.   ]]> https://biospectrumindia.com/features/82/17145/elastomer-stoppers-with-flurotec-film-the-right-choice-for-sars-cov-2-vaccines.html https://biospectrumindia.com/features/82/17145/elastomer-stoppers-with-flurotec-film-the-right-choice-for-sars-cov-2-vaccines.html Thu, 03 Sep 2020 00:00:00 +0530 Development and distribution of a vaccine for SARS-CoV-2 presents challenges that are, without hint of exaggeration, unprecedented. One of these challenges concerns storage, namely selection of vial/stopper primary package systems that guarantee quality and safety of the vaccine from manufacture through delivery. This selection is complicated greatly by the accelerated timelines for vaccine approval.   Two aspects comprise the challenge in package system selection: The first concerns the vaccine platform. Six platforms are now considered; they are listed with their proposed vehicles in Table 1. (1) Noteworthy is that two of them (RNA, DNA) are new. Ordinarily, there would be no difficulty in selecting a package system for any of the platforms, since ample time would be available for evaluation of compatibility with both the vaccine and the vehicle. But, for a SARS- CoV-2 vaccine, this is not the case, since approval timelines are accelerated. So, whether the vaccine platform is extant or new, selection of the package system must be made quickly. This creates a risk. The second concerns stability during storage and distribution. A vaccine platform and package system may be identified, but other factors must be considered, such as:          ■ Form: serum or lyophilized          ■ Delivery: multi- or single-dose          ■ Temperature: room (25oC), refrigerated (2-8oC), or low (-80oC)          ■ Availability of package system components Lack of certainty regarding whether a package system is available, and can accommodate the format needed, creates a risk.   Table 1. Potential Vaccines for SARS-CoV-2 (1) Vaccine Platform Chemical Composition Vehicle Existing, Licensed Human Vaccine RNA nucleotides (ribose groups, amino/amide groups, charged phosphate groups) encapsulated in lipid in non-polar liquid No DNA nucleotides (ribose groups, amino/amide groups, charged phosphate groups) aqueous (saline) solution, encapsulated in lipid in non-polar liquid No Recombinant Protein polypeptides (amino acid groups) aqueous Yes (baculovirus and yeast expression) Viral Vector Based virus shell comprises proteins (i.e., polypeptide: amino acid groups) aqueous Yes (vesicular stomatitis virus) Live Attenuated virus shell comprises proteins (i.e., polypeptide: amino acid groups) aqueous Yes Inactivated virus shell comprises proteins (i.e., polypeptide: amino acid groups) aqueous Yes   This is discussed in a new report by West scientists: Elastomer Stoppers with FluroTec Film:The Right Choice for SARS-CoV-2 Vaccines. To download the report or learn more about the FluroTec Film,please contact Shraddha.Sharma@Westpharma.com   Amanat, F. and Krammer, F. SARS-CoV-2 Vaccines: Status Report. Immunity, 52, 583-589 (April 14, 2020)   (This article is abstracted from Ranjana Singh, Ph.D., William Garzon-Rodriguez, Ph.D., Peggy Frandolig, Cathy Zhao, Ph.D. and T.Page McAndrew, Ph.D. Elastomer Stoppers with FluroTec Film: The Right Choice for SARS-CoV-2 Vaccines) ]]> https://biospectrumindia.com/features/82/17139/real-time-data-analytics-to-predict-and-manage-risky-process-deviations-.html https://biospectrumindia.com/features/82/17139/real-time-data-analytics-to-predict-and-manage-risky-process-deviations-.html Wed, 02 Sep 2020 00:00:00 +0530 Out of control processes in pharma manufacturing are not something to take lightly. If your production runs are seeing frequent deviations, leading to expensive batch losses or frequent rework, it’s time to take a look at ways to correct any process deviations in a more expedient manner. Uncorrected deviations or processes that vary from approved process parameters can lead to costly and dangerous mistakes. You don’t want to wait until you have regulatory warnings or face fines before taking steps to avoid risking a patient’s health and safeguarding your processes and company’s reputation. One of the most effective ways to ensure your processes stay within their approved critical quality attributes is with real-time process monitoring It’s not enough to hope that training and operator experience will do the trick, or that your team will be able to handle the most common types of process deviations quickly. You need a more reliable and quantifiable method that ensures patients' health, and your compliance with FDA and regulatory guidelines.   Multivariate Monitoring in Real-Time Using advanced data analytics models in real time gives your team more confidence in your process performance. A real-time analytics tool such as SIMCA®-online allows you to know when a process is performing optimally or to see immediately when a deviation occurs. This early warning allows you take the necessary steps right away to correct any issues that might cause a batch to be rendered unusable or to stop contamination of a downstream process.   Why a Multivariate Data Analytics Tool? A real-time multivariate analytics solution utilizes regression models to summarize all of the individual data points from various operations into multivariate models that can be monitored in real time. This becomes very efficient in the control room because instead of looking at a large number of individual parameters or signals, your operators have a small set of summary parameters that let them monitor all the variables at the same time. This makes it easier to notice changes in the process as they happen.   What Can SIMCA®-online Do? SIMCA®-online is the real-time data analytics tool from Sartorius that lets you use data from all your processes in a proactive way. With SIMCA®-online you can: Monitor in real time. You can create an ideal model of your process and then compare your actual data for the process to the model in real time. Predict with confidence. The multivariate analysis model provides a basis for predicting quality parameters over time using regression analysis. Using this tool, you can predict the final critical quality attributes with a high degree of confidence. Control at a glance. SIMCA-online with its real-time drill downs let you pinpoint issues and detect problems with equipment as they happen.   SIMCA®-online gives you: Remote golden batch monitoring Multivariate predictive monitoring Fault detection Root cause analysis Automatic corrective recommendation   Predicting the Future Effective process monitoring using data analytics doesn't have to stop at monitoring what’s happening right now. The right data analytics tools can also help predict the future for a process given the parameters of the current production state. A great feature of SIMCA®-online is the module called Control Advisor. Control Advisor is a supervisory type of control tool that advises you how you should run your process to avoid problems before they arise and to get optimal final results.   India Contacts: Vaibhav Patil Vaibhav.Patil@Sartorius-Stedim.com +91 99514 56508 Lohit Tirukappa Lohit.Tirukappa@Sartorius-Stedim.com +91 99020 36211   Visit www.umetrics.com to download a 30 day free trial of SIMCA®-online and Control Advisor.   ]]> https://biospectrumindia.com/features/82/16473/six-trends-shaping-the-asian-biopharma-supply-chain-.html https://biospectrumindia.com/features/82/16473/six-trends-shaping-the-asian-biopharma-supply-chain-.html Mon, 01 Jun 2020 09:00:00 +0530 The landscape is shifting rapidly for Asia’s biopharma and broader health sciences sector which has been thrust to the center of the global battle against COVID-19. The world is changing, and visionary leaders are evolving new strategies. What are the big trends which will impact future manufacturing, production and biopharma supply chains.   1. Getting breakthrough solutions to market, faster Making medicines faster and cheaper has long been part of a new normal. But against the ever-present debate on quality and cost, we see broader innovation only accelerating. The dominant theme? Re-imagining what production actually looks like, not just where it’s located. As big global companies ramp up output, the need for technology that increases productivity should grow.     At the same time, smaller companies are stepping up to take bigger roles. One example is EQRx. This global start-up wants to do for pharma what Southwest Airlines did for air travel1 – not reinvent the airplane but reassemble the supply chain experience while lowering the cost. The goal to bring new products to market faster is reflected right across Asia. There is significant investment across all sub-sectors of healthcare start-ups, including med-tech and biopharma2, where more players are expected in fields like cell, gene therapies and small molecules3.   2. Going for green: environment-friendly packaging will drive more sustainable solutions Consumers are now demanding products manufactured and delivered through sustainable processes, from sustainable companies. And while pharma packaging in particular presents waste issues, more sustainable solutions are on the rise, particularly in the most challenging temperature range to sustain: between 2-8°C. For instance, one life sciences company in Asia is successfully distributing IVF culture media to as many as 14 countries across what are often 96-hour journeys using Medpak VI°C, a recyclable rent-and-return solution. Others are using the service to distribute products like heart valves. Companies don’t buy Medpak boxes, but rather, only pay for using the 100% recyclable packaging, which is then collected and re-used. Similarly, active temperature-controlled specialty containers like C-Safe, which eliminate the need for gel packs or dry ice, will remain in demand – particularly for transporting temperature sensitive active pharmaceutical ingredients (APIs). [Learn more about FedEx temperature-controlled shipment]   3. Re-defining and re-thinking supply chain and delivery systems The wide spectrum of pharma-related businesses, including biopharma multinationals, have always placed a heavy emphasis on sound contingency planning. It’s built into the industry’s profile, which is naturally more susceptible to the impact of any supply chain disruptions. It’s no longer about “Plan A” in the face of unforeseen events such as COVID-19. It’s about “Plan B” and “Plan C”, and even a back-up strategy for those scenarios. In turn, that’s pushing the logistics team to re-configure supply chains, all the way from design to navigation and operations. Central distribution hubs are playing an increasingly critical role. Take for instance, Singapore, ranked as Asia’s top logistics hub for more than 10 consecutive years4.  There are now more than 50 biopharma manufacturing plants in Singapore with an output of close to US$ 21 billion – that’s over 21% of Singapore’s total manufacturing activity5. Singapore’s central location, multi-modal access, connectivity, professional talent pool and a robust R&D ecosystem are becoming increasingly crucial for biopharma. For FedEx, it’s about how we drive critical biopharma products through our network – and accelerate changes to make supply chains more adaptable, whether by air, road or sea. As a key player connecting global commerce, we can flex up or down as needed and this has been crucial this year in the capacity-constrained environment.   4. Greater manufacturing agility here to stay As the race to discover, develop and market medicine accelerates, examples of differentiated, value-specific supply chains for different product types are appearing everywhere. This is not just a biopharma trend. Examples of “as-a-service” supply chain models for specific products are evolving right across the healthcare space, which for FedEx includes not just pharma, but life sciences, clinical trials and med-tech. The COVID-19 crisis acutely highlighted the need for agility. Fears over severe shortages of antibiotics and other medicines have grown. With the prolonged closure of China’s factories, the vulnerability of the pharma supply chain6 became clear. Now governments and companies around the world are increasingly scouting for alternative sources7. [Click here to discover how FedEx healthcare solutions can help your business become more flexible] For instance, one leading high-end audio OEM has a supply chain that spans a select few countries – Singapore, Malaysia and the Philippines included. They’re flexing manufacturing so more than one country can assemble their market-leading medical devices, in response to ever-changing conditions and reduce dependency on one market.   5. Don’t be complacent when it comes to future innovation Just as many businesses are finding new, cost-effective ways to prioritize sustainability, the future can be seen in technology that’s changing transportation and logistics itself. Already, drone-delivered medical supplies are on the horizon, with a first-of-its-kind FedEx trial8. While this trend may be largely directed at residential package delivery, it’s easy to imagine that one day, air delivery drones might deliver vaccines for pharma – or even blood or tissue samples for clinical trials into the 2020s.  [Click here to see how FedEx elevates clinical trial processes with innovative solutions] Whatever the future, and even when the COVID-19 pandemic subsides, contactless delivery is set to increase, as digitally-enabled delivery trends like Roxo, the FedEx SameDay Bot, are further developed over time.   6. Sharp growth will create unique logistics challenges The global biopharma market is expected to reach US$269.3 billion by 20249, thanks to the industry’s ability to treat previously untreatable diseases10. Yet as Asia Pacific increases its dominance in this space, so do the opportunities and challenges. The pharma supply chain, including biopharma, will continue to seek flexibility in how it manages its supply chain. For example, one player - for whom we ship bioproducts - chooses to “broker select” 11, using their own specialist for custom clearance, while accessing the logistics, quality assurance expertise and reliable network of FedEx. Such solutions demand tight integration and strong collaboration and is a big step towards more flexibility and choices for the customer thus increasing customer confidence. The message? Reliability of delivery is just as or maybe even more important than speed12 as we adapt to the healthcare supply chain of the future.     [1] https://www.forbes.com/sites/leahrosenbaum/2020/01/12/a-pharma-startup-launches-with-200-million-in-funding-and-a-strategy-to-make-drugs-faster-cheaper/#6cd17f5459d3 [2] Singapore Business Review, https://sbr.com.sg/markets-investing/in-focus/new-startup-sectors-gain-ground-vcs-fill-coffers [3] Singapore Business Review, https://sbr.com.sg/markets-investing/in-focus/new-startup-sectors-gain-ground-vcs-fill-coffers [4] World Bank, as highlighted by EDB, https://www.edb.gov.sg/en/our-industries/logistics-and-supply-chain-management.html [5] SAPI-commissioned Deloitte Report, https://www.sapi.org.sg/wp-content/uploads/2018/05/Deloitte-Thought-Paper.pdf [6] https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30459-1/fulltext [7] https://www.straitstimes.com/asia/east-asia/japanese-companies-urged-to-cut-supply-chain-reliance-on-china and https://www.nytimes.com/2020/03/11/business/economy/coronavirus-china-trump-drugs.html [8] https://newsroom.fedex.com/newsroom/drone-deliveries-coming-soon-as-wing-unveils-plans-for-first-of-its-kind-trial-with-fedex-and-walgreen/ [9] https://www.businesswire.com/news/home/20190624005782/en/Global-Biopharmaceuticals-Market-Projected-Grow-8.7-2025 [10] https://www.mordorintelligence.com/industry-reports/global-biopharmaceuticals-market-industry [11] http://www.fedex.com/gp_english/international/customsservices/intbroker.html. [12] https://www.fedex.com/en-us/healthcare/knowledge-center/solutions/healthcare-supply-chain-future.html ]]> https://biospectrumindia.com/views/82/15681/biopharma-freight-in-asia-growing-cost-pressures-drive-smarter-risk-management.html https://biospectrumindia.com/views/82/15681/biopharma-freight-in-asia-growing-cost-pressures-drive-smarter-risk-management.html Thu, 30 Jan 2020 00:00:00 +0530 As biopharmaceutical production accelerates in Asia, global manufacturers are becoming increasingly exposed to supply chain risks on Asian trade lanes. For those dealing with high-volume products, smart management of freight shipments will be crucial for commercial success.   Successful strategies will require biopharma executives to maintain a delicate balance. They face constant pressure to contain costs but have minimal tolerance for supply chain disruptions and quality breaches. And with biopharma supply chains getting increasingly complex and globalized, their job is becoming more challenging every year.  Mounting Cost Concerns While many biopharma multinationals posted strong financial market performance in 2019, most also face growing cost pressures. Nearly $200 billion in pharmaceutical sales is at risk due to patents expiring over the next 5 years, according to a recent report by EvaluatePharma, a market research firm.1 With patent cliffs looming for many of the industry’s biggest blockbusters, heightened competition from biosimilars is right around the corner.  For some biopharma companies, margin erosion for off-patent blockbusters will be offset by launches of new, innovative medicines. Many of these new launches will require strict temperature management, driving continued growth in cold chain transport expenses [Click here to know more]. Total revenues for biopharma cold chain logistics exceeded $15 billion in 2019, according to the 2019 Biopharma Cold Chain Sourcebook, and the figure grows every year.2 At the same time, government-led cost containment measures may compress biopharma margins even further. Many Asian countries—including major pharmaceutical markets like Japan and South Korea—are already implementing policies to accelerate the shift to biosimilars and limit reimbursement on novel medicines.  With so many cost pressures on the horizon, biopharma companies will increasingly seek greater efficiencies at all points on the biopharma cold chain [Click here to know more], from upstream processes involving movement of ingredients between factories to downstream delivery of finished products to end-user markets.  Balancing Costs and Risks Most supply chain managers know that total costs are a function of more than just the sticker price of transport and logistics services. One service or approach may be less expensive, but it imposes risks that can generate even greater costs down the road, for example, from mishandled products or unanticipated delays. Such risks should be clearly assessed and accounted for during contract negotiations.  Some logistics providers, for example, achieve cost reductions by outsourcing services to various third parties. Yet every time a product changes hands, it raises risk that problems will happen during the handover or due to lack of coordination between different stakeholders. For this reason, biopharma companies should opt for closed-loop logistics services [More here on FedEx solutions for healthcare sector], with all operations and monitoring managed by in-house teams with a shared quality management system.  Other logistics providers are actively promoting ocean freight as a lower-cost alternative to air freight. This may make sense for manufacturers that can tolerate slower transport times, or those that are moving more time-sensitive ingredients or finished products between nearby countries, such as Japan and South Korea. Although FedEx primarily provides air freight services, multi-modal transport solutions are available in collaboration with FedEx Logistics, a sister company within the FedEx family. For most manufacturers with high-value products, however, air freight will remain the best option due to its speed and reliability. It also carries fewer risks, particularly in the wake of IMO2020, a new international regulatory regime that aims to reduce the environmental impact of marine fuel. These regulations may not only increase ocean freight costs, but also lead to supply chain delays due to retrofitting or denied port calls.3 [Learn more on how FedEx makes regulation compliance easy]. Year-end capacity issues during peak seasons—a period that encompasses the Western holiday season and the Lunar New Year holidays in Asia—present further risks. As spikes in demand for consumer products put strain on trade lanes, biopharma manufacturers face the ever-present prospect of surging freight prices. They can also cause delays that yield further costs due to re-routing, repackaging, storage, and product spoilage.  One option for avoiding unexpected costs is to work with logistics providers that can offer stable and predictable pricing during seasonal fluctuations in demand. Given its large air fleet, FedEx has more control over its own network than many freight forwarders, so it can manage volumes better and minimize peak season price surges.  Ultimately, every biopharma company will have its own cost considerations, risk appetite, and preferred approach to logistics. When seeking a logistics provider, flexibility and agility are paramount, so look for an experienced solutions team that understands your business and can customize its approach to the unique needs of your business.   Contact FedEx Healthcare/ Pharma Specialists: Click here For any other enquiries you have for FedEx: Click here 1 EvaluatePharma World Preview 2019, Outlook to 2014 – 12 th Edition, June 20192 Pharmaceutical Commerce: Biopharma Cold Chain Sourcebook 20193 See Box Lines Brace for Bumpy End to 2019 in AirCargoNews (Jul 2019) ]]> https://biospectrumindia.com/features/82/15290/sartocheck-5-plus-filter-integrity-tester.html https://biospectrumindia.com/features/82/15290/sartocheck-5-plus-filter-integrity-tester.html Mon, 09 Dec 2019 00:00:00 +0530 Sartorius introduced the very first Sartocheck® Filter Integrity Tester in 1980 and over a period spanning more than 3 decades, Sartocheck® Filter Integrity Tester evolved into an extremely sophisticated automated integrity test solution which is preferred by customers across the globe. Sartocheck® 5 Plus Filter Integrity Tester, the latest upgrade to the Sartocheck® product line, is the outcome of extensive research and customer-centric approach to optimize the detection of operator errors, improper test setups and out-of tolerance environmental conditions. Its patented software and sensor technologies make the new Sartocheck® 5 Plus Filter Integrity Tester the most advanced filter integrity tester yet that surpasses the requirements of Quality Risk Management (QRM). All these elements ensured that Sartocheck® 5 Plus Filter Integrity Tester wins the iF Design Award in 2018. This is how Sartocheck® 5 Plus Filter Integrity Tester meets key industry requirements for filter integrity testing even in the most demanding environments.   Automatic detection of incorrect test setups and test conditions All diffusion and WIT programs can be defined with a minimum expected value. If the measured value falls below that setting it is evidence that something is wrong, for example, the filter being tested is blocked, the wrong filter type is being tested or the downstream valve is closed. The bubble point programs can be defined with a minimum flow expected to be achieved at the end pressure of the test. (Image 1)         If the actual bubble point exceeds a certain level it is considered atypical. The BPmax (if set to lower than Pend) allows detection of these atypical situations. Pend is set in order not to exceed the pressure resistance of the filter setup and will terminate the test, even if the bubble point has not been reached. (Image 2)   When a filter is being tested, it always generates a certain pressure decay. If a pressure increase is detected instead of a pressure decay, it may indicate a temperature change or that the downstream side of the filter is being pressurized. (Image 3)     Faster Testing The Sartocheck® 5 Plus Filter Integrity Tester tests the duration of diffusion and water intrusion testing can be significantly reduced by using the automatic test time. When activated, the test will be truncated if the test value of 10 subsequent measurement points is stable within a pre-defined range. (Image 4) The accelerated bubble point of the Sartocheck® 5 Plus Filter Integrity Tester uses progressively larger pressure steps once the minimum bubble point has been exceeded by one pressure step. This results in a faster bubble point test with fewer pressure steps, yet with the same stringent accuracy at the critical pass/ fail threshold of the minimum bubble point. (Image 5)   Data Integrity Sartocheck® 5 Plus Filter Integrity Tester uses a custom Linux-based OS with Sartorius Stedim Biotech custom architecture to provide inherent protection against virus and malware attacks for maximum security. The route file system is write protected making it impossible for a virus to reside in the system. All data generated is instantly backed up on the internal inaccessible 8 GB SD card. This prevents any loss of data even in the unlikely event of system crash. The encryption protects data to prevent its disclosure, theft or misuse. All GMP relevant actions are time stamped in the audit trail to comply with 21 CFR part 11. When parameters are changed, before and after values are displayed so that full traceability of “who did what and when” is sure data integrity also includes a reliable time stamping of the events. When Sartocheck® 5 Plus Filter Integrity Tester is connected to the network and NTP function is activated, automatic time zone synchronization occurs thus generating reliable time stamps in the audit trail. Barcode scanner allows seamless data entry during programming of the test. The barcode scanner can be set to mandatory to ensure a much safer, faster test procedure.   Ease of Use   12.1 inch touchscreen with a viewing angle of 88° contributes to ease of use regardless of the operators’ height and position. The screen is also compatible with gloves. Sartocheck® 5 Plus Filter Integrity Tester supports Lightweight Directory Access Protocol (LDAP) which allows all operators to utilize their network credentials to access the device. It supports local users with the option to transfer user and user roles, while still ensuring fulfilment of password complexity and supervised password ageing   Automation   The Modbus TCP protocol is a commonly used industrial automation protocol. Compatibility to other automation network control protocols like DeviceNet, Profinet, etc. can be achieved by using third-party gateways (Image 6). Sartocheck® 5 Plus Filter Integrity Tester supports two automation modes: Semi-automated: A full test recipe can be sent to and stored on the device till an operator logs in and starts the test. Fully automated: A full test recipe can be sent to the device following which the test can be started and monitored by an MES.   Health , Safety and Enviroment  (HSE) Integrity testing often involves the use of chemicals and hazardous materials. The Sartocheck® 5 Plus Filter Integrity Tester is certified for use in explosion hazardous areas (ATEX), this allows safe testing of IPA wetted filters and is also compatible with all current cleaning agents and VHP. This ensures maximum safety for operators and manufacturing facilities. It is also rated a splash-proof (IP64) for performance under the most stringent conditions in wet environment. Continuous and clear visualization of pressure status avoids mishandling by operator while system is under pressure. PFA tubes flow path of Sartocheck® 5 Plus Filter Integrity Tester are FDA 21 CFR 177 and USP Class VI compliant. Automated cleaning of all pneumatics with up to 0.5 M NaOH at 50 °C using an optional cleaning kit is possible. ]]> https://biospectrumindia.com/features/82/14801/-enhanced-assurance-of-supply-for-single-use-bags.html https://biospectrumindia.com/features/82/14801/-enhanced-assurance-of-supply-for-single-use-bags.html Tue, 01 Oct 2019 00:00:00 +0530 Apala is a microbiologist by training and has been involved in establishing Sartorius Stedim Biotech’s Fluid Management Technologies portfolio in the Indian biopharmaceutical market. Apala has a background in vaccine manufacturing. Sartorius Stedim Biotech introduced the first single-use bag for biopharmaceutical applications and now we see rapid adoption of single-use bags in commercial production of biopharmaceutical drugs. The entire supply chain for single-use bags is complex and requires material science and film expertise to achieve consistent quality attributes of film, bags and single-use assemblies. This raises new challenges for bag suppliers and drives the need for consistent product quality, improved assurance of supply, robust change management and business continuity planning. Sartorius Quality by Design, material science, film extrusion knowhow and bag making expertise are the foundation of our single-use solutions that offer robustness, performance, process safety and cost effectiveness. Assurance of Supply (AOS) for our SU bags are built on partnerships, supply contracts, quality agreements and the control of our entire manufacturing processes from the resins to the final product (refer image 1).    Resin specifications and process controls for our PE film of Flexsafe® and EVA film of Flexboy® and Celsius® provide Raw material traceability Lot-to-lot consistency   Extrusion design space and process control for films provide Excellent & reproducible cell growth Consistent robustness Lot-to-lot reproducible extractable profiles   Long-term supply contracts, safety stocks & quality agreements provide 10-year supply contract for films and 2-year customer change notification 2-year last time buy option for films 2 years of demand safety stocks for resins & films 2 years change notification for fluid contact components   Supply chain for single-use commercial manufacturing needs to be robust as any change may affect the quality of the drug product. This is why Sartorius Stedim Biotech has an extremely stringent change control in order to offer our customers Assurance of Supply (AOS). This industry leading Assurance of Supply (AOS) is the result of a global supply network and expansion of our manufacturing footprint worldwide. We have built strong partnerships and established long-term quality & supply agreement with key suppliers. By controlling our entire supply chain and manufacturing process, we ensure consistent quality, change control and busines ]]> https://biospectrumindia.com/features/82/14414/model-predictive-control-of-batch-processes-with-umetrics-suite-of-data-analytics-solutions-.html https://biospectrumindia.com/features/82/14414/model-predictive-control-of-batch-processes-with-umetrics-suite-of-data-analytics-solutions-.html Fri, 09 Aug 2019 00:00:00 +0530 In the pharmaceutical industry, it is becoming increasingly clear that predictive process models and advanced analytics can be of enormous assistance in solving many of the unique challenges. Advanced data analytics tools are used by industry to find the golden nuggets in historical data, aid in process development, fine-tune production, and achieve long-term improvements in product quality and throughput. Even if one uses highly advanced real-time analytics, they can only analyze what has happened up to the current time point. They are unaware of the problems that will occur further on in the process. The ideal scenario will of course be to have the ability to predict the future of the process and use that information to avoid future problems from happening. If we know and understand the future, we can make changes upfront to improve future results. Figure 1 illustrates an ongoing process highlighting the actual and expected trajectory of the process.   Figure 1: Actual trajectory of a process (black dotted line) & expected trajectory (green line) emphasizing the unknown nature of future trajectory. How to predict the future Let us approach this with a simple example, assume there are two process variables- x1 & x2 that are correlated (Figure 2). Figure 2: Correlated variables, x1 and x2. If we only measure x1, we can refer to the historic data and plot our estimates onto a scatter plot. We can draw the line of best fit and use it to estimate the likely results of x2 for new measurements of x1 (Figure 3). The method to get these values is called imputation. Figure 3: Using correlation to impute the missing value of x2 from x1 In real-world applications, similar estimations of future values of critical process parameters are done using sophisticated missing value imputation algorithms that involve multiple variables at the same time. This is how we arrive at the predicted “open loop” future performance in figure 4. Figure 4: Actual trajectory of a process (black dotted line), expected trajectory (green line) and predicted “open loop” future performance of the rest of the process (blue dotted line). Model Predictive Control: How to use predictions to optimize performance Model predictive control or statistical process control is a methodology where one can use predictions to control and optimize a process. The goal is to find the best future settings of your process variables, in order to arrive at the desired outcome of your future process. For example, if you run a biological process, you might collect data for variables such as pH and temperature. Model predictive control can then be used to adjust the future values of the variables, in this case pH and temperature to optimize the future of the process. Umetrics®’ SIMCA-online has a powerful tool, Control Advisor, which forecasts and advises future mode for desired outcome. How Control Advisor works in practice Control Advisor can be used in both continuous processes and batch type processes. Control Advisor uses existing measurements of the process (up till current time point), future known setpoints and the multivariate model to propose smart adjustments to critical process parameters; this is illustrated in figure 5. Figure 5: Actual trajectory of a process (black dotted line), expected trajectory (green line), predicted “open loop” future performance of the rest of the process (dark blue dotted line) and predicted “closed loop” future performance following a process intervention as suggested by Control Advisor (light blue dotted line). Visit www.umetrics.com to download a 30 day free trial of SIMCA-online and use Control Advisor. India Contacts – Vaibhav Patil - Patil@Sartorius-Stedim.com | +91 99514 56508 Lohit Tirukappa - Lohit.Tirukappa@Sartorius-Stedim.com | +91 99020 36211 ]]> https://biospectrumindia.com/features/82/11553/distinct-perspectives-on-life-sciences-trends.html https://biospectrumindia.com/features/82/11553/distinct-perspectives-on-life-sciences-trends.html Mon, 27 Aug 2018 14:15:00 +0530 Life Sciences is a constantly evolving field. Staying uo-to-date with these evolutions, especially for busy executives who carry expertise and interests on these grounds is a task, yet it is highly necessary to keep a track of these evolutions. What poses as a challenge is trying to find relevant and reliable sources to ensure one gets the right piece of information.  The online magazine portal BioSpectrum India is one such forum that stages the ever-evolving and on-going developments in these fields, providing access to a wide range of information covering areas from biotechnology, biopharma & pharma to life sciences, medical technology and healthcare. https://enterprise-services.siliconindiamagazine.com/vendor/biospectrum-india-distinct-perspectives-on-life-sciences-trends-cid-5900.html https://enterprise-services.siliconindiamagazine.com/ranking/20-most-promising-online-magazine-websites-2018-rid-411.html   ]]>