https://biospectrumindia.com/rssfeed/bio-interactions/white%20paper white paper https://biospectrumindia.com/reports-white-papers/33/27428/the-ai-revolution-in-clinical-trials-new-research-reveals-why-industry-leaders-are-making-the-shift-now.html https://biospectrumindia.com/reports-white-papers/33/27428/the-ai-revolution-in-clinical-trials-new-research-reveals-why-industry-leaders-are-making-the-shift-now.html Thu, 05 Mar 2026 00:00:00 +0530   New research from Medidata reveals a remarkable shift: 73% of AI users confirm that the AI integration has met or surpassed their initial expectations, while over 70% report gains in protocol design, site feasibility, and cohort identification. These aren’t incremental improvements – they represent breakthrough results that are fundamentally changing how the most successful organizations conduct clinical trials.  The Numbers Tell a Compelling Story The data is striking. Among global clinical research professionals surveyed on their use of AI in their clinical trials: 70% of users confirm tangible improvements in data accuracy, addressing one of the most critical challenges in clinical research 61% of users cite streamlined data collection processes, eliminating bottlenecks that have plagued the industry for decades 83% of AI-using companies are leveraging AI for patient population and cohort identification, optimizing one of the most complex and time-consuming aspects of trial design  93% of organizations employ AI for data capture and oversight – ensuring data integrity throughout the entire trial lifecycle Perhaps most telling is that 93% of organizations are either already using or actively investigating AI for their trials. The question is no longer whether to implement AI, but how quickly can organizations scale these capabilities to remain competitive.  Transforming Every Phase of the Trial Lifecycle Leading organizations are discovering that AI’s impact extends far beyond a simple application. The most successful implementations integrate AI across key aspects of clinical trials: Patient Engagement & Retention: As trials grow increasingly complex, retention has also become harder than ever. AI is helping address this by enabling patient-centric engagement – over 50% of AI users are deploying personalized communications, automated reminders, and conversational chatbots that provide 24/7 support.  These tools complement the human touch, allowing clinical teams to focus on complex patient needs while AI handles routine interactions.  Data Quality & Oversight: AI is stepping in to make data management cleaner, faster, and more reliable. With 93% of AI-using companies employing the technology for data capture and oversight, organizations are achieving unprecedented levels of data integrity and real-time visibility into trial performance.  Regulatory Reporting: AI can play a critical role in essential regulatory and operational functions. Looking ahead, 59% of current AI users plan to leverage the technology for Clinical Study Report (CSR) preparation and submission – potentially transforming one of the most time-consuming aspects of bringing therapies to market.  Unlock Your Competitive Advantage Today The research reveals a clear message: Organizations embracing AI today are gaining a competitive edge. They’re conducting studies faster and more cost-effectively while maintaining or improving quality standards. Meanwhile, those waiting on the sidelines are falling further behind as time passes.  However, successful AI implementation is not about rushing to adopt any technology. It requires a strategic approach that evaluates high-impact use cases, ensures robust data governance, and leverages proven platforms designed specifically for clinical research.  This is where choosing the right partner becomes critical. Organizations achieving the best results are not cobbling together point solutions, they are working with comprehensive platforms that integrate AI seamlessly across the entire trial lifecycle, from protocol design to regulatory submission.  Discover What AI Can Do for Your Trials Medidata’s The State of AI in Clinical Trials: Today and Tomorrow provides detailed insights from over 200 global clinical trial executives on how AI is transforming their operations and what strategies are delivering the strongest results.  The findings reveal not just where the industry is today, but where it’s headed, and how forward-thinking organizations are positioning themselves to lead in this new era of clinical research. Ready to discover how AI can accelerate your trials while improving quality and reducing costs? Download the complete whitepaper to explore the full research findings, including detailed breakdowns of AI adoption by use case, implementation strategies from industry leaders, and a roadmap of scaling AI capabilities within your organization.  ]]> https://biospectrumindia.com/interviews/33/26344/scaling-car-t-for-india-how-scalereadys-g-rex-grant-is-empowering-immuneel-therapeutic-.html https://biospectrumindia.com/interviews/33/26344/scaling-car-t-for-india-how-scalereadys-g-rex-grant-is-empowering-immuneel-therapeutic-.html Tue, 08 Jul 2025 00:00:00 +0530 Earlier this year, Immuneel Therapeutics achieved a significant milestone by becoming one of the first Indian companies to receive regulatory approval for the commercial sale of a CAR-T therapy. However, as patient demand surged, Immuneel faced the challenge of scaling its all-in-one manufacturing platform—known for its clinical reliability but limited in cost-effective expansion. Recognising this bottleneck, ScaleReady stepped in with its G-Rex® Grant, selecting Immuneel as a strategic partner in India. Josh Ludwig, Global Director of Commercial Operations at ScaleReady, speaks with BioSpectrum India about how this collaboration marks a turning point in industrial-scale cell and gene therapy (CGT) manufacturing in emerging markets. He delves into how the G-Rex® platform optimises production efficiency, enhances facility throughput, and lays the groundwork for more affordable access to advanced therapies across India and beyond.   What made Immuneel Therapeutics the right fit for this G-Rex® Grant, and how does it reflect ScaleReady's vision for cell and gene therapy in emerging markets like India? Immuneel has received approval from India’s regulatory bodies for commercial production and sale of a CAR-T product earlier this year. The all-in-one-manufacturing platform Immuneel has used to date, to generate the clinical data and manufacture the commercially-approved CAR-T product, is a well-known and widely disseminated all-in-one platform. However, that all-in-one-manufacturing platform is not able to scale out in a cost effective manner, and therefore Immuneel is unable to meet the patient demand for its CAR-T drug. Immuneel recognized that a change of manufacturing platform is needed to enable scaled manufacture, and that the G-Rex platform would enable it to achieve the cost-effective scale out needed meet the demand for its CAR-T drug. Hence, Immuneel Therapeutics was an ideal candidate and ultimately recipient, for a G-Rex grant. How does the G-Rex platform uniquely support industrial-scale CAR-T manufacturing, especially in cost-sensitive geographies like India? All-in-one manufacturing system have the common disadvantage of leaving portions of the system idle for long periods of time. Ultimately that limits throughput, increases cost, including a huge amount of wasted facility space. Prodigy provides a good example of all-in-one manufacturing system deficiencies. As but one example, Prodigy integrates cell separation technology that typically separates T-cells from other cells. The process takes about 2 hours. Thereafter, the T cells are moved into a chamber in the all-in-one-system where cells are typically expanded in quantity for 7 days. Meanwhile, the cell separation technology is completely idle, doing nothing but taking up space during the 7 day expansion period. In a G-Rex centric manufacturing process, no equipment remains idle. While in an all-in-one manufacturing system, the cell separation equipment sits unused while cells are in the expansion phase, a G-Rex process is able to perform T cell isolation for one patient after another, each patient taking 2 hours. With regards to patient throughput, I have included comparisons of each stage here:   During each 8-hour shift of a G-Rex process, cells can be isolated from the apheresis of 4 patients per shift using a G-Rex approach. With one 8-hour shift per day, in 7 days a G-Rex process can initiation drug product manufacturing for 28 patients compared to only 1 patient for Prodigy.   With two 8-hour shift per day, in 7 days a G-Rex process can initiation drug product manufacturing for 56 patients compared to only 1 patient for Prodigy.   With three 8-hour shift per day, in 7 days a G-Rex process can initiation drug product manufacturing for 84 patients compared to only 1 patient for Prodigy. The advantages of G-Rex go far beyond just starting more patient manufacturing process per day in a G-Rex process versus the all-in-one-systems – it also enables a more efficient use of space. During the cell expansion stage, G-Rex can process 48 patients in the amount of space occupied by just one all-in-one manufacturing system. With a projected demand of 200 doses per day, what production and delivery efficiencies does this collaboration aim to unlock in the short and long term? We anticipate the ultimate benefit of the collaboration with be two-fold. First, the cost of CAR-T drug product manufacturing inclusive of labor, burden and material will be merely $18,000 plus the cost of the genetic engineering construct. Second, due to the much higher patient throughput per sq. ft. of facility in comparison to all-in-one-systems, the size of the manufacturing facility will be much smaller than is possible with all-in-one-systems, thereby significantly reducing up-front capital expenditures. What role do you foresee for public-private partnerships in supporting the scalability and affordability of CAR-T in India? Our knowledge in that area is evolving. We are consistently seeing that the governments of low to middle income countries are deeply interested in bringing CAR-T to their citizens, and therefore expect that governments will be eager to reduce the barriers to achieving that objective. Could you share examples from other regions or partners where the G-Rex grant has enabled successful translation of cell therapies from lab to clinic? Through the G-Rex Grant Program, we are collaborating with entities in most parts of the world, including in Asia (India, China, South Korea, Japan, Thailand, Nepal, etc.), Latin America (Mexico, Argentina, Brazil, Chile, etc.), the Middle East (Turkey, Saudi Arabia, Qatar, Israel, UAE, etc.), Oceania (Australia and New Zealand), and much of Western and Eastern Europe.  In fact, about half of our ~300 G-Rex Grants are to entities outside the United States seeking to transition to G-Rex from their current platform.  To us, this represents evidence that those emerging markets value the simplicity, cost- and space-efficiency, and flexibility that the G-Rex approach offers. Are their future plans to expand? Yes - through CellReady, the world’s only G-Rex centric manufacturing facility, we intend to adopt the lean manufacturing efficiencies that were established by entities such as McDonalds to transcend existing CGT manufacturing limitations. That will allow expansion of McDonalds style CGT manufacturing centers globally and result in worldwide dissemination of the world’s most affordable CGT drug products. (ankit.kankar@mmactiv.com ) ]]> https://biospectrumindia.com/features/33/26345/court-states-that-maternity-leave-is-a-vital-right-for-women-in-the-workforce.html https://biospectrumindia.com/features/33/26345/court-states-that-maternity-leave-is-a-vital-right-for-women-in-the-workforce.html Tue, 08 Jul 2025 00:00:00 +0530 This landmark observation, delivered during a recent case involving a woman denied leave for her third child, highlights the evolving role of maternity insurance and health insurance for parents in safeguarding family and workforce interests. This declaration not only protects the rights of mothers but also reinforces the broader healthcare ecosystem that must adapt to the changing realities of Indian families and workplaces. Maternity leave as a constitutional necessity In a strong statement, the apex court ruled that maternity leave is not merely a benefit or privilege, but an enforceable constitutional right. The case pertained to a woman government servant who had applied for maternity leave following the birth of her third child. Despite existing Central Civil Services Leave Rules limiting benefits beyond two children, the Supreme Court underscored that no woman should be forced to choose between employment and motherhood. The court noted that maternity leave plays a critical role in protecting the health of both the mother and the child. This stands aligned with international conventions as well, including the Maternity Protection Convention of the International Labour Organization, which India has ratified. Intersection of maternity insurance and employee rights With the court’s emphasis on maternity as a right, the focus is now shifting to adequate coverage through maternity insurance. In India, most comprehensive health plans now include some form of maternity benefit, but there are caps, sub-limits, and waiting periods that often make access difficult for many women, especially in the private workforce or informal sector. Maternity insurance typically covers: Hospitalisation costs during delivery (normal or C-section) Pre-natal and post-natal expenses Newborn care (up to 90 days in some policies) Vaccination and consultation costs in certain plans However, many health policies require a waiting period of 9 months to 4 years before these benefits can be accessed. This presents a barrier for newly married or expecting couples who did not plan early. Given the court's stand, there is likely to be more regulatory pressure on insurers to offer more inclusive maternity insurance options. Role of health insurance for parents in household security While maternity insurance focuses on new life, health insurance for parents remains a parallel concern for many families, especially when managing finances across generations. With rising healthcare costs and increased life expectancy, ensuring elderly parents have access to quality treatment is essential. Many employers now offer health insurance for parents as an add-on benefit under group health schemes. These policies provide: Coverage for pre-existing diseases (subject to waiting periods) Cashless hospitalisation Access to a wide network of hospitals Option for top-up or super top-up policies for additional protection As more Indian households adopt nuclear family structures, providing health insurance for parents becomes not only a financial strategy but also an emotional commitment. The combination of maternity benefits for new mothers and health coverage for aging parents is a balanced way to secure all generations of a family. Impact on women’s participation in the workforce The Supreme Court’s reiteration of maternity rights is a step toward closing the gap in female workforce participation. Many women in India either leave jobs during pregnancy or are denied re-entry into the job market due to lack of supportive infrastructure. Recognising maternity leave as a legal right, regardless of the number of children, could help improve workforce retention and gender equality. Workplaces with inclusive maternity policies often report higher employee satisfaction, better long-term productivity, and lower attrition rates among women employees. Employers may also need to revise their HR policies in line with judicial guidance to avoid future legal risks. Public and private sector response While government employees are typically entitled to 180 days of paid maternity leave, private sector policies vary significantly. The Maternity Benefit (Amendment) Act, 2017 mandates 26 weeks of paid leave for establishments with more than 10 employees. However, implementation and enforcement remain inconsistent. Given the court’s directive, the Insurance Regulatory and Development Authority of India (IRDAI) may consider introducing guidelines that mandate maternity coverage in all comprehensive individual and family health policies. Additionally, incentives could be provided to insurers who offer maternity benefits without excessive waiting periods. The path forward for inclusive healthcare This judicial ruling should prompt both government bodies and private employers to re-examine their healthcare policies. A more inclusive approach to maternity insurance and broader health insurance for parents can promote a healthier workforce and family structure. Moreover, awareness drives are needed to educate employees, especially women, about their legal rights and healthcare options. Many workers remain unaware of the benefits they can claim or the insurance they are eligible for. Building a culture of informed decisions and proactive planning is essential to bridge this gap. Conclusion Maternity leave is not merely a personal need; it is a societal responsibility and a constitutional right, as reaffirmed by the Supreme Court. This judicial clarity strengthens the case for better maternity insurance, comprehensive health coverage, and improved support for working women. As India advances toward a more equitable and health-conscious future, equal emphasis must be placed on both ends of the family spectrum—ensuring new mothers are cared for through maternity benefits, while elderly parents are protected through health insurance. When combined, these safeguards form the foundation of a healthy, balanced society.   ]]> https://biospectrumindia.com/reports-white-papers/33/22188/bone-marrow-derived-human-mesenchymal-stem-cell-production-in-corning-hyperstack-36-layer-cell-culture-vessels.html https://biospectrumindia.com/reports-white-papers/33/22188/bone-marrow-derived-human-mesenchymal-stem-cell-production-in-corning-hyperstack-36-layer-cell-culture-vessels.html Mon, 31 Oct 2022 00:00:00 +0530   MSCs have the potential to differentiate into other mesenchymal tissue lineages such as adipocytes, osteocytes, and chondrocytes1. Additionally, they are known to secrete trophic factors that can play an important role in immunoregulation1. Although MSCs can be isolated from different tissue sources, bone marrow-derived MSCs are commonly studied due to their ease of access and achievable therapeutic dosage (2 x 106 cells/kb of body weight)2,3. Here, we demonstrate the utility of the Corning HYPERStack 36-layer cell culture vessel as a tool to meet the growing demand for expanding bone marrow-derived MSCs to relevant scale for clinical application workflows. The utilization of gas permeable film technology provided in the spatial footprint of a traditional stacked cell culture vessel enables Corning HYPERStack cell culture vessels to provide up to 5X the surface area in the same spatial footprint for expansion of adherent cell types, such as MSCs. Our results show that over 870 million human bone marrow-derived MSCs can be obtained from a single HYPERStack 36-layer cell culture vessel. Furthermore, harvested cells demonstrated high viability and expressed characteristic surface markers of human bone marrow-derived MSC identity.   Materials and Methods Human bone marrow-derived MSCs (RoosterBio Cat. No. MSC- 1M-5XF) were thawed into T-175 flasks (Corning Cat. No. 431080) containing RoosterNourish™-MSC-XF (RoosterBio Cat. No. KT-016) per vendor’s recommended protocol. Upon achieving 90% confluence, cells were harvested with TrypLE™ Express Enzyme (ThermoFisher Cat. No. 12604021) and centrifuged at 200 x g for 10 minutes. Cells were re-plated in Falcon® 875 cm2 Multi-Flasks (Corning Cat. No. 353144) at a density of 3 x 103 cells/cm2. After five days of culturing in a humidified, 5% CO2 incubator at 37°C, cells were harvested as previously described and seeded into pre-warmed Corning HYPERStack 36-layer cell culture vessels (Corning Cat. No. 20036) at 3 x 103 cells/cm2. It is recommended to pre-warm the Corning HYPERStack 36-layer cell culture vessel at 37°C to prevent any temperature gradients during the seeding process. Human bone marrow-derived MSCs were expanded in the HYPERStack cell culture vessels for five days, then Cells were harvested and assessed for yield and viability. The expansion from cryogenic vial thaw through HYPERStack 36-layer cell culture vessel expansion was repeated three independent times. To confirm MSC identity, approximately 1 x 107 cells were stained (BD Biosciences Cat. No. 562245) per vendor protocol and CD surface antigens assessed via flow cytometry. Results and Discussion Human bone marrow-derived MSC densities ranging from 4.4 x 104 to 5.2 x 104 cells/cm2 were achieved after 5 days of culture in Corning HYPERStack 36-layer cell culture vessels (Figure 1). The average of all three studies resulted in a total MSC yield of more than 8.7 x 108 cells per HYPERStack 36-layer cell culture vessel. For therapeutic application workflows, it is essential to recover MSCs that have high viability and express appropriate surface markers4. In these studies, MSCs collected from HYPERStack 36-layer cell culture vessels showed greater than 90% average viability (Figure 1). The International Society for Cellular Gene Therapy (ISCT) has defined the minimal criteria for human bone marrow-derived MSC quality as expressing >95% of CD105, CD73, and CD90 and lack of expression (<2%) of typical hematopoietic markers CD45, CD34, CD14 or CD11b, CD79a or CD19, and HLA-DR surface molecules4. Human bone marrow-derived MSCs recovered from HYPERStack 36-layer cell culture vessels were characterized via flow cytometry, and displayed greater than 99% expression of CD90, CD105 and CD73 while expressing less than a half a percent of negative markers (CD45, CD34, CD11b, CD19, and HLA-DR).   Conclusions The growing number of clinical trials involving stem cells used for therapeutic applications has led to an increase in demand for tools and technologies that enable efficient scale-up of stem cells, without compromising cell viability and cell health. Here we demonstrate that the Corning® HYERStack® 36-layer cell culture vessels offers an effective method for expanding large quantities of human bone marrow-derived MSCs that maintain high viability and appropriate surface marker characterization. References Kassem M. Mesenchymal stem cells: biological characteristics and potential clinical applications. Cloning and Stem Cells (2004) 6.4:369-374. Musiał-Wysocka A, Kot M, and Majka M. The pros and cons of mesenchymal stem cell-based therapies. Cell Transplant (2019) 28.7:801-812. Hassan M, et al. Large-scale expansion of human mesenchymal stem cells. Stem Cells International (2020). Robb KP, et al. Mesenchymal stromal cell therapy: progress in manufacturing and assessments of potency. Cytotherapy (2019) 21.3:289-306. ]]> https://biospectrumindia.com/reports-white-papers/33/15878/new-white-paper-alert-analytical-solutions-to-detect-sartan-impurities.html https://biospectrumindia.com/reports-white-papers/33/15878/new-white-paper-alert-analytical-solutions-to-detect-sartan-impurities.html Sun, 01 Mar 2020 00:00:00 +0530 Need for robust and highly sensitive analytical solutions to detect Sartan impurities Determine genotoxic nitrosamines in ARB class of drugs with gas chromatography and mass spectrometry techniques Angiotensin-receptor blockers (ARBs) or sartans are among the most widely used medicines for hypertension and heart failure. After nitrosamine impurities were discovered in valsartan by the US FDA & EMA, the industry saw several costly global recalls by various global regulatory authorities. The US FDA and EMA have recommended that manufacturers of ARBs (sartans) review their manufacturing processes so that they do not produce nitrosamine impurities and after a transition period with very strict limits on the levels of these impurities, their generic sartans should contain no quantifiable levels of these impurities. The Thermo Scientific™ TSQ™ 9000 triple quadrupole GC-MS/MS system can detect trace levels of these genotoxic impurities in complex drug matrices while meeting all the sensitivity and repeatability requirements of current regulations and exceeding the requirements of the much stricter control limits expected in the near future. Click here to download the Application Note ]]> https://biospectrumindia.com/reports-white-papers/33/13939/white-paper-advanced-compliance-for-use-in-regulated-sectors.html https://biospectrumindia.com/reports-white-papers/33/13939/white-paper-advanced-compliance-for-use-in-regulated-sectors.html Wed, 19 Jun 2019 12:00:00 +0530 White Paper: Advanced Compliance For Use in Regulated Sectors Sartorius's Cubis® II is designed to follow US FDA data integrity principles that require data to be accurate, legible, contemporaneous, original, and attributable (ALCOA). The Cubis® II balance, with pharma package, contains all the technical controls to support compliance with common regulations. Full compliance can be achieved with additional procedural controls and systems for long-term data storage. Click Here to Download White Paper  ]]>