Xcellerex’s XDRbioreactors are well suited for production processes that require the use of anchorage-dependent cell lines grown on microcarriers. The bioreactor agitation assembly is the driver for these factors. To assure robust bioreactor operation, the M40Eimpeller was designed to perform well above the minimal mixing constraint for uniform gas distribution and fluid homogeneity and well below the maximum shear constraint to assure a viable and productive cell population. Cell lines such as Vero, MDCK, and…
2011
Development and GMP Manufacturing of Biopharmaceuticals
Richter-Helm BioTec is a dynamic and expanding biotechnology company located in Hamburg, Germany. Being one of the first biopharmaceutical enterprises in Europe, Richter-Helm has more than 20 years of experience in the development and GMP-compliant production of recombinant proteins, plasmid DNA, and microbial vaccines. With more than 120 employees Richter-Helm offers customized state-of-the-art solutions for all steps in biopharmaceutical projects through contract development and manufacturing services in GMP facilities for microbial production (fermentation scale up to 1,500 L). Beside our…
CMO Selection Criteria
Selecting a CMOis critical to biotech biologic drug development. A key factor for selecting a CMOis experience. How do you measure experience? It can be measured in many ways, metrics include Number of GMP processes developed by the CMO Number of projects involving your strain Number of projects involving your product type GMP production success rate Number of GMP lots produced. Eurogentec’s Biologics Division is specialized in the manufacturing of biopharmaceuticals from microbial sources such as bacteria, yeast, and biosafety…
Seal Intrusion — A Hidden Cost
The following is an extract from a paper presented at the Orlando ISPE Annual Meeting on November 2010 by Dr. John Toynbee. Seal or gasket material protruding into the process flow within pipework carries a number of production issues, many of which have serious cost implications. Areas of seal intrusion or recess are caused by oversized or undertightened gaskets that create a trap at the clamp union. This creates a number of production problems: System drainage and cleaning are compromised…
Viral Clearance Services at Lancaster Laboratories
The risk of viral contamination is a feature common to all biotechnology products produced by processes that use cell lines and raw materials of animal origin. Such contamination could have serious clinical consequences, and worldwide regulatory bodies expect that the viral safety of these products be ensured. Viral clearance studies are performed as one way of demonstrating viral safety. The studies are executed by intentionally adding or “spiking” large amounts of virus into the starting material for individual manufacturing steps…
Performance Characterization of Batch-Fed Nonadherent CHO Cell Culture in Rocker Bags
Disposable cell culture bags are used in conjunction with rocker platforms in an array of cultivation applications (insect and mammalian cell lines, virus, protein expression). Rocking platforms provide the dynamic motion and oxygen transfer for cell culture environments. Disposable culture bags are designed to allow for a large air-liquid surface for oxygen transfer, easy access for sampling/filling, and a sterile environment. Venting issues have been reported in the field during rocking of disposable cell culture bags. Therefore, venting and cell…
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…
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…
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…
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…