Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D; community with critical information on the tools, technologies, and trends that drive the biotech industry.
Issue link: http://gen.epubxp.com/i/83770
Bioprocessing In addition to investing in single-use tech- nologies to meet customer demands for short- er project timelines, a few CMOs have been investing in fill-and-finish capacity. These CMOs are able to provide their clients with a one-stop-shop solution thereby reducing the logistics and coordination between two different CMOs. This helps speed delivery of clients' drug product. Laureate Biopharma (www.lbios.com), Boehringer Ingelheim and WuXi Apptec have recently made investments in fill-and- finish services. Laureate completed improvements to its formulation and filling operations, including new analytics for formulation development and upgrades to its fill suites, resulting in im- proved process flow. "Laureate has invested $8 million in its manufacturing facilities and equipment, qual- ity systems, and analytical equipment," said Lisa Cozza, vp of business development. Other CMOs are also undertaking initia- tives to improve product timelines for their customers. CMOs are adopting tools and techniques that will speed cell-line devel- opment, and facilitate their clients' clinical studies. For example, CMC Biologics is of- fering faster cell-line development services. "Our custom CHEF1® cell-line de- velopment platform provides expression solutions for both monoclonal antibodies and glycoprotein production," said Claes Glassell, CEO. "The platform has been de- signed to deliver clonal research cell banks capable of producing more than 2 g/L of recombinant antibody in 12 weeks from transfection." CMC has also recently offered a new pro- gram to its clients that it reports delivers clini- cal-scale monoclonal antibodies in 12 months. Also working to reduce project timelines for its clients, Gallus recently announced that it has begun to collaborate with Theo- rem Clinical Research (www.theorem.com) to provide their clients with seamless inte- gration between their CRO and the contract manufacturer. This collaboration stream- lines the clinical studies activities with manu- facturing development and production. "This addresses a flaw in the current in- dustry norm where CRO and CMO services are not linked and yet there is a vital role to play in delivering efficient and effective clinical development to clients," said Mark R. Bamforth, president and CEO at Gallus Biopharmaceuticals. New Capabilities CMOs continue to implement new ca- pabilities that either speed product develop- ment or improve product quality. "Sandoz has successfully implemented its microbial autoprotease fusion expression technology (Npro) for two clinical candidates at 1,300 L and 3,000 L scale. The technol- ogy is available for partners of Sandoz," said Friedrich Nachtmann, Ph.D., head of biotech cooperation at Sandoz (www.sandoz.com). Sandoz recently scaled-up the PEGylation of proteins to the 13,000 L scale and success- fully integrated this process into its down- stream manufacturing operations. In order to meet customers' demands for better formulations, Wacker Biotech (www. wackerbiotech.com) offers an alternative to PEGylation processes in cooperation with XL-protein (www.xl-protein.com). "Many customers are currently looking for better formulations and, in particular, for technologies to improve the plasma half-life of biopharmaceuticals to reduce the dosing frequency," explained Thomas Maier, Ph.D., managing director of Wacker Biotech. "In contrast to the established chemical modification of the drug molecule with poly- ethyleneglycol (PEGylation), the new technol- ogy, PASylation®, offers a means to geneti- cally fuse the therapeutic protein with a non- immunogenic polypeptide comprising proline (P), alanine (A), and serine (S) residues and so increase the hydrodynamic volume." "PASylation has the advantage of avoid- ing an expensive and poorly selective chemi- cal modification step during production and eliminates the need of additional purifica- tion. Moreover, unlike the chemical polymer PEG, the PAS amino acid sequences are bio- degradable and therefore do not accumulate in cells or organs. We have already reached high production titers of 3 to 4 g/L for PASyl- ated human growth hormone." When purity is key... …you need a trusted biologics manufacturer, from gene to drug products With Novasep's CMO services, you benefit from: Q Global upstream and downstream capabilities Q Experience with an extensive array of expression systems Q Biosafety level 2 and 3 cGMP facilities Q Expertise in disposable and reusable technologies Q Full quality and regulatory support * Through its expert process development services, Novasep guarantees your process performance. www.novasep.com Contact: biopharma@novasep.com - Tel.: USA +1 610 494 0447 - Europe: +33 3 83 49 71 43 Scan to learn more Genetic Engineering & Biotechnology News | genengnews.com | October 1, 2012 | 43 ELOOLRWWH IU • • • 3KRWR FUHGLW 1RYDVHS