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Dateline:  China, 13 April 2015

How do new biotechnologies promote the development of the pharmaceutical industry?

Interview with Dr. Udit Batra, CEO and President of EMD Millipore

In recent years, emerging biotechnologies covering areas as diverse as gene editing, next-generation genetic sequencing, and disposable biological products, have not only driven the rapid development of preclinical medicine, they have also created huge business opportunities for pharmaceutical companies, transforming the entire industry landscape.

Monoclonal antibody (mAb) drugs emerged in the late 1990s, and have since played a critical role in the global pharmaceutical industry. In 2014, mAb-class drugs accounted for 50% of the world's top 10 best-selling drugs. This in turn has driven significant progress in a range of different medical research fields including cell therapy, stem cell therapy, and immune cell therapy. Breakthroughs from this research have enabled the development of new therapies for major diseases such as cancer, cardiovascular diseases, diabetes, degenerative diseases, and autoimmune diseases, among others.

In 2014, a major advancement was achieved in the field of tumor immunotherapy based on PD1 and PDL1 targets amid a flood of reports from various pharmaceutical companies detailing fresh successes. These results bring patients more hope that they will succeed in their battle against cancer. Gene therapies in particular have attracted a lot of investment following advances in gene editing technology.

A number of key biotechnologies and specialized equipment are essential to the development and production of these new bio-therapies, such as cell processing and cultivation, protein analysis, and preparation of biological samples. The development of these technologies and instruments is critical to the creation of new biological therapies and clinical applications. At present, biopharmaceutical companies do not need to invest too much energy on general production processes. For example, companies producing monoclonal antibody drugs are primarily concerned with research and development on how to select optimal cell strains in order to produce highly-effective antibodies. Such tasks can be handled by equipment suppliers, which play an indispensable role in the production chain of antibody drugs, especially in the present industry environment, where disposable production processes are being widely used in the biopharmaceutical industry.

EMD Millipore is the biotechnology division of Merck KGaA, Darmstadt, Germany, and a leader in the field of biological research and biopharmaceutical equipment innovation. In 2014, Merck announced the acquisition of another multinational biotechnology company, Sigma-Aldrich. Although Sigma-Aldrich and EMD Millipore have yet to complete the integration process, EMD Millipore is expected to become a giant in the field following the acquisition. In order to fully appreciate the contribution of new biotechnologies to the pharmaceutical industry, Guo Jianfu, Chief Editor of BioonGroup, recently interviewed Dr. Udit Batra, CEO and President of EMD Millipore during his latest visit to Shanghai.

In the past decade, biopharmaceutical solutions have become more mature in terms of research ideas and production methods. In his interview, Dr. Udit Batra introduced the complete range of EMD Millipore's solutions in the biopharmaceutical field. EMD Millipore provides end-to-end production process technology, and develops systemic solutions pertaining to the molecular structure of drugs, various processes, and disposable bioreactors. Disposable bioreactors are widely applied by biopharmaceutical companies, and are valued for their flexibility. They are capable of producing different types and sizes of products, making them suitable for developing treatments for a variety of diseases and indications, as well as responding to changeable market demands. Moreover, the investment cost of disposable bioreactors is far less than the cost of the larger stainless steel versions, and they also shorten the cycle of plant construction, verification and batch replacement.

EMD Millipore's clients include preclinical medicine research institutions and research & production departments of pharmaceutical companies. Dr. Udit Batra also said that EMD Millipore provides support to the whole industry chain, from early studies of drug targets, to drug manufacturing. EMD Millipore offers a complete product line of disposable bioreactors ranging from 50 L to 2000 L for the upstream chain. It ensures drug safety and effectiveness, while providing customers with the most optimized process solutions, thus maximizing productivity. EMD Millipore also provides support to protein purification and cell analysis processes for downstream sectors.

In light of the optimistic outlook of the biotechnology industry, EMD Group acquired Sigma-Aldrich last year. Dr. Udit Batra said the specific acquisition process is expected to be completed in mid-2015. Through this acquisition, EMD Millipore's product line will be significantly expanded, including its antibodies business, analytical reagents, and cell culture media business. The competiveness of its three businesses will receive a huge boost from Sigma-Aldrich. With the rapid development of e-commerce in the industry, Sigma-Aldrich will improve EMD Millipore's sales capacity and service offering. Sigma-Aldrich itself has established a very successful e-commerce platform that will increase the quantity of EMD Millipore's products beyond the 60,000 it currently offers worldwide. Sigma-Aldrich also occupies a large market share in the laboratory scientific research sector, where EMD Millipore has long been a key player.

With the biotechnology industry set to enter an era of exciting growth, EMD Millipore has a very optimistic view of the prospects of the Chinese market. Although Chinese labor costs have risen, and the government has reduced tax benefits for foreign-funded companies, EMD Millipore will still increase its investment in China, including research & development, due to strong demand for biotechnology products in the Chinese market. EMD Millipore owns an 8% - 9% share of the global market, but only a 5% - 6% shared of the Chinese market, suggesting the company has huge potential for further growth in China. EMD Millipore is currently working with Fudan University on drug research & development and plans to invest more in its production facilities in China.