Genetic Engineering & Biotechnology News

OCT1 2012

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.

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Bioprocessing CMOs Focus on Technology Improvements William Downey and Dawn Miles Over the past decade, planned average annual capacity growth in the biopharmaceutical contract manufacturing industry has slowed. This situation reflects both recent market conditions and a shift in investment priorities by biopharmaceutical contract manufacturing organizations. CMOs have realigned their investment plans to focus on productivity improvements, lower costs, and better asset utilization. This change in investment policy is docu- mented in HighTech Business Decisions re- cent report, "Biopharmaceutical Contract Manufacturing: New Participants, Expand- ed Services and Emerging Markets." Planned capacity increases, measured by bioreactor volume in liters, for both microbial fermen- tation and mammalian cell culture have slowed over the last seven years. In 2005, CMOs expected to add ca- pacity at a rate of 13% per year. Over the subsequent years, expected annual capacity increases have steadily declined. In 2011, CMOs planned to add capacity at a rate of 3% per year. The CMOs interviewed for this article gave examples of the investments they are making to meet the current and future indus- try needs. While new planned expansions have slowed, the CMO industry continues to take advantage of current biotech industry con- ditions. On July 31, CMC Biologics (www. cmcbio.com) acquired Xoma's (www.xoma. com) large-scale manufacturing operations and affiliated assets in Berkeley, CA. CMC Biologics has taken over the lease of buildings and three 2,750 L stainless steel bioreactors and two purification suites. CMC Biologics has already put a management team in place, and it expects the new facility to be fully operational by the end of this year. Following the sale of its production facil- ity, Xoma announced that it had entered into an agreement with Boehringer Ingelheim (www.bioxcellence.com) to manufacture gevokizumab, Xoma's interleukin 1-beta allosteric modulating antibody. Boehringer Ingelheim will manufacture this product for both Xoma and its partner Les Laboratories Servier (www.servier.com). CMC Biologics' acquisition deal with Xoma is the most recent involving biomanu- NEWS Bioprocessing > GE Healthcare Launches Modular Biopharmaceutical Factory GE Healthcare introduced KUBio™, an off-the-shelf, modular factory. According to Olivier Loeillot, general manager of en- terprise solutions, GE Healthcare Life Sci- ences, KUBio's pre-made modules, which are assembled at a customer's chosen site to make a ready-to-run bioprocessing facility, are "significantly faster to install than constructing a traditional factory. KUBio, which is designed to meet cGMP requirements, comprises a 1,200 m2 " facility that is prefabricated and delivered with a complete production line, based on GE Healthcare's Ready-to-Process™ single-use technologies. "With a total planning, delivery and con- struction time of 14–18 months, compared to the traditional 24–36 months, both time- to-market and level of capital investment are significantly reduced, " explains Loeillot. "The first modular facilities to be introduced will be configured for the manufacture of monoclonal antibodies. GE Healthcare also plans to introduce modules for the manu- facture of other biopharmaceuticals. > Cobra Biologics and Algeta Sign Agreement to Manufacture Monoclonal Antibody Cobra Biologics and Algeta entered into a new contract manufacturing part- nership for Algeta's fourth targeted tho- rium conjugate program. The agreement will focus on the de- velopment of an undisclosed monoclonal antibody, which reportedly is highly se- lective for a validated cell surface target on hematological cancer cells, linked to Algeta's alpha-particle emitter tho- rium-227 (Th-227). Cobra will provide cell line develop- ment through its maxXpress service, GMP cell banking, analytical and process devel- opment, scale-up, toxicology, and GMP production, as well as stability studies. > Sartorius Opens Bioreactor Production Facility to Expand Manufacturing Capacity Sartorius has opened its new plant in Guxhagen in northern Hesse for the manufacture of bioreactors. Approximately 18 million euros were invested in the facility, which covers a total area of nearly 10,000 square feet. The com- plex provides space for a high-tech manu- facturing hall and offices for approximately 240 employees. 40 | October 1, 2012 | genengnews.com | Genetic Engineering & Biotechnology News By opening this new site in Guxha- gen, Sartorius has moved from its former bioreactor production facility in Mel- sungen, Germany, where it had reached maximum capacity limits, said a Sartorius spokesperson. > Cellceutix Chooses Dr. Reddy's Labs for Production of Prurisol Cellceutix concluded negotiations and selected Dr. Reddy's Laboratories for the manufacturing of Prurisol™, the com- pany's new drug candidate for the treat- ment of psoriasis. Dr. Reddy' s will manufacture Prurisol for oral dosing at levels sufficient for the com- pany' s planned Phase II/III. Currently in meet- ings with clinical sites in Europe and the U.S., Cellceutix expects to begin clinical trials upon completion of the manufacturing. Q Using its PASylation technology, an alternative to PEGylation, Wacker Biotech has reached production titers of 3 to 4 g/L for human growth hormone. facturing capacity made by a CMO in the past year and a half. Last year, Boehringer Ingel- heim, and Fujifilm, and Gallus BioPharmaceu- ticals (www.gallusbiopharma.com) each made major biopharmaceutical manufacturing ac- quisitions from drug innovator companies. Boehringer Ingelheim purchased Amgen's (www.amgen.com) Fremont, CA, biomanu- facturing facility. Fujifilm bought Merck & Co.'s (www.merck.com) contract manufac- turing business, and re-named it Fujifilm Diosynth Biotechnologies (www.fujifilmdio synth.com). Closely following these two ac- quisitions, Gallus BioPharmaceuticals pur- chased Centocor's St. Louis, MO, manufac- turing facility in May 2011. Capacity Investments While CMOs continue to add capacity, they are generally doing so in smaller incre- ments, and they are focusing on productivity and quality improvements to meet market demands. Most CMOs interviewed for this article are adding or have added single-use bioreactor capacity. Investing in single-use bioreactors allows for gradual increases in capacity at economically reasonable costs. Both large and small CMOs are installing single-use bioreactors. See CMOs on page 42

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