Japan is the third largest economy in the world. Its chemical (and classical drug) industry is fully mature, and it is a founding member and major participant in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) project. The country’s aging population represents an attractive market to outside drug companies. Some well-known vendors to the bioprocess industry are headquartered in Japan, including Tosoh Bioscience and Shimadzu Scientific Instruments. “Japanese companies have become so…
Wednesday, June 1, 2011 Daily Archives
Nomenclature of New Biosimilars Will Be Highly Controversial
Biopharmaceuticals, including products approved as biosimilars, must be clearly defined, identified, and named to ensure accuracy in writing and filling prescriptions (1,2,3,4). The US biosimilars law enacted last year enables the Food and Drug Administration (FDA) to approve abbreviated biosimilar biologics license applications (bBLAs) or 351(k) filings based largely on their sponsors proving structural, composition, and clinical similarities with an approved biologic (reference product), much like generic drug approvals (5). The agency has yet to disclose how it will implement…
India
India is well known as a key destination for bioprocess outsourcing and a major supplier of active pharmaceutical ingredients and raw materials. The global pharmaceuticals manufacturing outsourcing industry is expected to reach US$100 billion by 2015 (1). India has the potential to capture 8–10% of this industry by 2015 and become one of the top 10 global markets by value (2). By comparison, India’s biotechnology industry (consisting of biopharmaceuticals as well as other sectors) has gained global attention…
France Biotech Presents Results of Its 2010 Life-Sciences Survey
France Biotech (the French association of life-science companies) presented the results of its “Life Science Panorama 2010†survey at the BioVision world life-sciences forum in Lyons, France, on 29 March 2011. The survey describes major trends for 2009–2010 in the life-science industry, both in France and internationally. More than 263 companies responded to the survey this year, and 211 were included in the final analysis. Main Trends in France Results of the latest survey attest to…
China’s New Five-Year Plan
In October 2010, the Communist Party of China’s Central Committee approved its 12th Five-Year Plan for National Economic and Social Development (FYP) (2011–2015), which it ratified on 14 March 2011. During those five years, China will continue to focus on government-guided economic development, industry, and technology. The FYP outlines the government’s commitment toward reforming its economy and increasing its domestic consumption to decrease its dependence on exports for future growth of its gross domestic product (GDP). Other initiatives…
A World of Innovation
The world faces a clear need for innovative biological products to treat and prevent diseases that cause significant health burdens. What might be less obvious is a need for innovation in biomanufacturing processes. If these products are to be made more efficiently and cost-effectively through less wasteful and safer means, then improvements are definitely needed. “We need innovations in downstream bioprocessing, whether the products are vaccines, recombinant proteins, or other bioproducts,” said Uwe Gottschalk, vice president of purification technologies at…
Australia
Australia is the only Asia–Pacific country that’s home to one of the world’s top-10 biotechnology companies (in revenue): CSL Limited, a maker of drugs, vaccines, antivenoms, blood products, and diagnostics. Many companies in the West consider this country a “gateway†to the Asia–Pacific region because of its relatively familiar culture, language, laws, and infrastructure. Indeed, Australia’s proximity to Singapore, Indonesia, Malaysia, and the rest of Asia compares favorably to the rest of the English-speaking world. For cell therapies…
Streamlining Downstream Process Development
Normal-flow filtration is used throughout downstream processes for biologics including depth, sterile, and viral filtration applications. Because of its ubiquity in large-scale biomanufacturing, using the most efficient normal-flow filter media area and type can lead to significant cost savings. But determining the most effective media type and area can be time consuming, labor intensive, and complicated because of a lack of specialized laboratory-scale equipment.
The equipment commonly used in this evaluation presents several disadvantages, including poor integration of multiple components from different sources (including pressure sensors, signal conditioning, data acquisition, balances, and pumps), continuous operator monitoring, and decreased portability of most systems due to their numerous components. This white paper describes how Genentech Inc. and PendoTECH collaborated on developing an integrated filter-sizing system that addresses these challenges and aids in efficient evaluation of filter media for manufacturing-scale processes.