SEOUL, KOREA — Merck Millipore, a Business Unit of the German Merck, supported the local Biotechnology Industry by sponsoring an event co-organized by the European Union Chamber of Commerce in Korea (EUCCK) and the Korea Health Industry Development Institute (KHIDI) in coordination with the Ministry of Health and Welfare, the Ministry of Knowledge Economy, the Korea Food & Drug Administration, Korea Biomedicine Industry Association and Korea Biotechnology Industry Organization. The event will offer a platform for international biopharma stakeholders to gather together in Korea to take stock of international regulatory practices and technology trends.
“Korea has always been looking for new business segments and industries with potentiality to be a growth driver for the nation. In its master plan, the Korean government has decided to promote and fund the biotechnology sector, aiming at becoming a global market leader by 2020 and starting with biosimilars”, emphasized the President and Representative Director of Merck, Juergen Koenig.
Ko Kyung-Hwa, President of Korea Health Industry Development Institute, said in her welcoming speech that “the global pharmaceutical industry faces productivity challenges due to rising development costs with fewer new drug launches every year. Therefore, the industry is in urgent need of narrowing its productivity gap and prompting future growth. Participants of this event will have a unique opportunity to look into the future of the pharmaceutical industry and R&D and discuss ways to drive innovation.” She introduced the forum as a follow-up event of the International Biotechnology Exhibition & Conference 2011 (BIO KOREA), held in September 2011, which was Asia’s largest biopharma event co-organized by North Chungcheong Province, KHIDI and Korea International Trade Association (KITA).
During the forum, Dr. Matthew S. Croughan gave a presentation on ‘Best Practices to Improve Titer in Cell Culture Process.’ He is director of the Amgen Bioprocessing Center, the world’s largest biotech company. Noting that local pharmaceutical companies face technical difficulties during the important cell culture process to produce biological drugs, he said “the volume of protein produced in the cell culture process contributes to manufacturing costs; the local pharmaceutical industry will get some practical help from this presentation.”
European and U.S. regulators are preparing for approval procedures to serve the biopharm industry, but many issues including IP protection, data exclusivity, CMC and non-clinical and clinical data requirements still remain uncertain.
Dr. Gregory S. Blank, Bioprocess Consultant: “Manufacturing medical products is an important part but filing with related authorities and winning regulatory approval is a long and complex period, which varies from country to country, making it difficult for local manufactures to export their products.” He did make a presentation on “Best Practices for FDA BLA Filing and Regulatory Approval Pathway” and also an analysis of the prospect on technologies related to cell purification, as culture technologies had been introduced during in the last session.
Therapeutic antibodies are emerging as a new paradigm in the development of new drugs and they represent 37% of all biological medicinal products currently under development. They also account for more than 20% of investigational drugs under the FDA’s review process. The market of therapeutic antibodies grows about 20% annually and the global market value reached around $27 billion in 2007 and recently surpassed $35 billion. About 30 kinds of therapeutic antibodies are being used in the treatment of patients and the number of these drugs is expected to increase to 55 by 2018.
Dr. Bala Raghunath, Director, Biomanufacturing Science Network for Asia, had focus on this area during his presentation ‘Rapid Low Risk Production of mAbs at Clinical Scale.’ “I will share my know-how on managing risks at research, clinical and commercial levels when using the monoclonal antibody technology, which is widely used for cell culture.”
A recent trend in the biotechnology industry represents ways to increase the potential and efficiency for drug development. To this end, the industry has adopted a chemical synthesis method to produce cell culture media rather than deriving it from animal serum, with which they try to maintain quality and control difficult-to-predict variables. In this field, a case study of Merck Millipore will help participants understand the technology trend. Merck has already provided the industry with its experience and know-how through many products. Through the successful acquisition of U.S. bioscience company Millipore in 2010, Merck has contributed to increase efficiency and productivity in the manufacturing process by providing a comprehensive range of products, technologies and services for pharmaceutical and biotech companies and labs around the world. Merck Millipore had its own booth at the forum and displayed feature materials in the processing of pharmaceutical and biological products, as well as those for purification and preparation and related regulatory documents. Merck scientists were available to answer questions.
The EUCCK expects this forum to serve as an opportunity for Korea’s pharmaceutical industry to access the potential to treat new diseases and further reduce side effects, providing a unique insight into the global market for the local industry in the face of challenges due to drug price reduction, a rapid rise of biological products and investment and the entry into the generics market by global players.
