Biocon's new biologics facility inaugurated

Finance minister, P Chidambaram recently inaugurated Biocon Biopharmaceuticals, claimed to be India's largest multi-product biologics facility at Biocon Park, Bommasandra Industrial Area - Phase IV.

Biocon established Biocon Biopharmaceuticals Private Limited (BBPL) in collaboration with CIMAB, representing the Centre of Molecular Immunology, Cuba. The state-of-the-art cGMP compliant facility is designed to manufacture a broad range of novel and bio-similar therapeutic products through large scale cell-culture fermentation for the treatment of cancer, auto-immune and metabolic diseases.

Kiran Mazumdar-Shaw, chairman and managing director, Biocon, said, "The facility is also designed to cater to contract manufacturing needs of international biopharmaceutical companies. Biocon's multi-disciplinary technological capabilities and growing expertise in clinical development has enabled rapid advances in the field of protein therapeutics. Biocon believes that such novel products of biotechnology will provide quantum growth drivers for the future."

The l,20,000 sft building spread over three floors comprises process, laboratory and technical support areas. The new facility represents a significant advancement in terms of technical sophistication over Biocon's existing facilities and comprises three distinct modules - cell culture module for monoclonal antibodies and other cell culture products; aseptic formulation and filling module for sterile products in vials, cartridges, lyophils and syringes; and quality control module.

Dr Arun Chandavarkar, president, operations, said, "The new facility is benchmarked to the highest regulatory standards and will position Biocon and Biocon BioPharmaceuticals as a key global player in the field of cell culture fermentation technology. The plant is designed with an in-built 4-fold expansion capacity keeping in mind Biocon Biopharmaceuticals' research pipeline and global market trends. This new facility will provide immediate job opportunities to over a hundred scientific and technical personnel."

IMRB survey reconfirms benefits of Bt cotton

As against the general notion about the failure of the cotton crop, IMRB International (a part of the WPP's Kantar Group of Companies) with over three decades of market research experience in India has found that farmers who planted Bollgard cotton earned an additional Rs 2,100 crore in income based on 3.125 million acreage penetration for the 2005 crop.

According to Nikhil Rawal, senior vice president and executive director, IMRB International, "This second IMRB survey of Bollgard has reconfirmed for us the earlier findings that farmers stand to benefit from the usage of this technology. A total of 31 districts were covered as part of the research out of the 80 cotton districts across cotton growing states in India. Better yields and less pesticide usage have been the key triggers for farmers choosing Bollgard over conventional cotton."

The IMRB International survey estimated that there has been a 64 percent or 4.16 quintals per acre increase in Bollgard yields when compared with conventional cotton. The net profit increase for farmers using Bollgard is Rs 6,727 per acre or over 118 percent. It also observed that there is a reduction of an average 2.4 pesticide sprays against bollworm that translates to a 25 percent reduction in total pesticides spend.

IMRB International interviewed 4799 farmers across 31 cotton-growing districts in Punjab, Haryana, Rajasthan, Andhra Pradesh, Karnataka, Tamil Nadu, Madhya Pradesh, Maharashtra and Gujarat. This survey reconfirms that for the fourth successive year, the benefits of Bollgard cotton to Indian farmers included better yields, reduced pesticide use and higher profits.

ICRI partners with Cranfield University

To drive an international perspective to clinical research education in India and to deliver on India's growing demand for skilled clinical research professionals, Mumbai-based Institute of Clinical Research (India) has entered into an academic alliance with Europe's research led institution, Cranfield University, the UK. This alliance would further the cause of ICRI in India in grooming professionals in clinical research to face exciting challenges posed by the pharmaceutical sector and also pave the way for new career opportunities in this field.

An agreement to this effect was signed between the two collaborating organizations in the presence of Vicky Treadell, the deputy high commissioner, British High Commission.

Commenting on the alliance, Dr SK Gupta, dean, Institute of Clinical Research (India) said, "The association with Cranfield University would help the ICRI to impart innovative education through an international exchange of knowledge dissemination in clinical research, which would further help deliver on the growing demand for highly skilled clinical research professionals in India."

Speaking on the occasion, Prof. Clifford Friend, deputy vice chancellor, Cranfield University said, "This alliance gives us an opportunity to address the growing demand for clinical research professionals in India. The perfect combination of ICRI's networking with the Indian pharmaceutical sector and their current course orientation and Cranfield University's distinctive competences in biomedical sciences and clinical research data studies bring immense potential to furthering the cause of clinical research in India."

Cranfield University would undertake responsibility for the quality academic orientation in clinical research and training methodologies, evaluative studies, project assessment, knowledge exchange and final certification of Cranfield-ICRI's two-year full time Masters program in clinical research.

Shasun to launch its first rDNA product in 2007

Recognising the role of biopharmaceuticals in the future of global pharmaceutical industry in enhancing therapeutic effectiveness, improving lifestyle quality and strengthening corporate profitability, Chennai-based Shasun Chemicals and Drugs Ltd, a premier service provider to the pharmaceutical industry has been engaged in developing technologies for recombinant biogenerics using the microbial expression platform. And it will launch its first biotech product r-Streptokinase in 2007.

Speaking to mediapersons in Mumbai, Govindarajan, CEO, Shasun Chemicals and Drugs Ltd said, "One of our product under development has successfully cleared animal toxicity studies and is under clinical testing. Meanwhile, we have developed capabilities in the area of biotechnology services like upstream and downstream processing, analytical and quality assurance. And the cGMP production facility for biopharmaceutical proteins is nearing completion. We are looking for tie-ups with suitable co-marketing partners to launch these products in the Indian market.�h

Shasun offers services in research, development and manufacturing (including Contract Research and Manufacturing Services- CRAMS) and set up its biotech R&D facility in 2002. Currently it has a team of 22 scientists. It is also looking for tech transfer and discussions are on with a couple of companies for the same, Govindarajan said.

Shasun reported a significant growth in the business of CRAMS as its revenue grew to Rs 38 crore in 2005-06 from Rs 24.5 crore (2004-05). The company recently acquired the pharmaceutical custom synthesis business of the Rhodia Group, the UK and is targeting to close FY07 with a Rs 750–800 crore and FY08 with Rs 1000 crore.

Indian groups oppose patenting of AIDS drug

The Indian Network of People Living with HIV/AIDS (INP+), the Manipur Network of Positive People (MNP+), represented by the Lawyers' Collective HIV/AIDS Unit officially submitted their opposition to a patent application filed in the Kolkata patent office by GlaxoSmithKline (GSK) for Combivir, a fixed-dose combination of two essential AIDS drugs zidovudine/lamivudine. The opposition is based on technical and health grounds.

"We are objecting to the patenting of Combivir because it is not a new invention but simply the combination of two existing drugs. More importantly, the granting of such a patent risks increasing the cost of anti-retroviral treatment for many people living with HIV/AIDS, thereby further increasing the burden on developing countries already struggling to treat patients," said KK Abraham, president of INP+. Combivir is a widely used fixed dose combination and is used extensively in projects run by international aid organization Medecins Sans Frontieres (MSF). Almost all the Combivir used by MSF is generic. India, Burkina Faso, Mongolia, Central African Republic, Malawi, Peru, the Republic of Kyrgizstan, Cambodia, Ukraine and Swaziland are other countries also identified by the Global Fund as using generic Combivir, the release said.

Mascon files its first patent in bioinformatics

Mascon Life Sciences has filed its first patent, which is also probably India's first patent as well, in the bioinformatics arena. This invention is in the field of theoretical biology. Here the DNA is converted into a unique signal, which is further processed in order to extract the needed biological features. The authors for the invention are Vivek Kumar Singh, Vivek Gangadhar Mahale and Dr Avinash Purusottam Agnihotry.

"This patent is in the basic sciences area and is going to revolutionize the entire bioinformatics research", commented Vivek Mahale.

"We have developed different mathematical models and functions for different biological features. The theory of decoding the DNA sequence into a unique signal is of very basic in nature and has produced remarkable results when applied to extract the features from a genome", said the Vivek duo.

According to Vivek Singh, "This work is in true essence the genius of mathematics applied to biology". He further added, "We have efficiently tackled problems like gene finding, promoter prediction, splice site detection, alternate splicing codon degeneracy and phylogenetic cluster analysis. The proposed algorithm was found far more efficient and accurate than even presently available ab-initio methods for coding region identification." "This is a fantastic job. This is the very first patent we have ever acquired as a group and a great accomplishment", said Gowri R Shanker, director, operations, Mascon Global Ltd.

The patent has been filed as Indian Patent vide Patent Application No. 953/DEL/2005, and the US patent has been applied for. The patent is titled "Method for conversion of DNA sequence to a number string and application therefore in accelerated drug design".

Panacea Biotec opens pharmaceutical formulation plant at Baddi

Panacea Biotec has commenced production in its new pharmaceutical formulation plant at Baddi, Himachal Pradesh with an investment of around Rs 45 crore. This plant is in compliance with global standards including US FDA and UK MHRA, SA MCC and WHO cGMP.

Situated amidst picturesque surroundings in the state of Himachal Pradesh, Panacea Biotec's facility in Baddi is spread over 70,000 sm and will cater to the manufacturing of oral and topical pharmaceutical finished dosage forms. The facility is equipped with modern equipment and machinery to meet the regulatory standards of the US, European and South African markets.

The Baddi facility with high capacities and scope for future expansion is designed to produce various formulations viz. tablets, capsules, ointments and liquids. The facility has an installed capacity of 900 million tablets, 120 million capsules, 12 million ointment/gel tubes and 1.2 million litres liquid orals per annum.

Inaugurating the plant, Rajesh Jain, joint managing director, said, "Our Baddi facility is a showcase of the latest in modern technology and is equipped with ultra modern and sophisticated machines and integrated packaging lines. The plant will produce high quality healthcare products accessible and affordable for all. This facility will give a competitive edge to the company as we continue to innovate and step up our growth strategy. This new manufacturing facility will support our future growth and facilitate rapid rollout of new products".