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Jul 1, 2011 (Vol. 31, No. 13)

CMOs Investing in Capacity & Capabilities

Ever-Increasing Demands from Clients Keep Contract Manufacturers on Their Toes

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    Wacker Biotech recently expanded and modernized its facility in Jena, Germany. Production at the GMP plant is based on microbial systems and uses the Densetec® high-cell-density method or the firm’s Esetec® E. coli secretion technology.

    The biopharmaceutical contract manufacturing industry continues to show signs of recovery with new expansions and acquisitions, although even in the face of the slowdown, most CMOs stated that they would continue to invest in capacity and capabilities in order to meet their clients’ long-term needs. The CMOs interviewed for this article continue to invest in capacity and capabilities, expect moderate industry growth this year, and see both opportunities and challenges ahead.

    In order to offer greater flexibility to their clients, CMOs are investing in new plants and equipment, analytical laboratories, and closer collaborations with a network of service providers.

    Many CMOs are also working to provide additional service offerings to their clients. In addition, CMOs across the board are investing in single-use bioreactors, which offer lower costs and faster turn-around for the smaller batch sizes often required by their clients.

    CMC Biologics is adding capacity at both its Bothell, WA, site and its Copenhagen facilities. This expansion supports additional commercial production for both mammalian cell culture and microbial fermentation production, and includes investment in single-use technologies.

    According to Claes Glassell, CEO, “the expansion plans started with the construction of a multipurpose single-use facility in Bothell, which was completed in 2010, and is expected to include the build-out of a facility to house two 5,000 L commercial-ready manufacturing lines.

    “In addition, CMC Biologics’ facility in Copenhagen, which offers both mammalian cell culture and microbial fermentation capabilities and is approved by the European Medicines Agency for the manufacture of commercial supply, plans to add a 2,000 L single-use bioreactor by the fall of 2011.”

    Joe McMahon, president and CEO at KBI Biopharma, reports, “We recently expanded our cGMP manufacturing capacity for mammalian cell culture in the form of Xcellerex® XDR bioreactors, with capacity up to 2,000 L. This line is designed for both clinical and commercial production and utilizes single-use technology.

    “The strategy behind our expansion was based on increasing demand for our services, including requests for the addition of more manufacturing capacity.”

    Wacker Biotech increased its capacity recently, according to managing director Thomas Maier, Ph.D. “We re-opened our GMP facility last year after an €18 million investment for expansion and modernization. This state-of-the-art unit meets the highest cGMP regulatory requirements, and it offers increased downstream capacity.”

    DSM plans expansions at its BioSolutions and Biologics businesses to support late-stage and commercial manufacturing. “Our customers will benefit from our expansion by a reduction in processing time. This will lead to further reduction of our customers’ commercial cost of goods,” states Marco Oomen, senior director, global marketing and sales at DSM BioSolutions.

    In addition to expanding capacity at its current sites, DSM Biologics is building a new facility in Brisbane, Australia, in collaboration with the Australian Federal and Queensland Governments. Karen King, president of DSM Biologics, notes that this initiative will “bring a world-class mammalian cell culture CMO operation to Australia.” The new facility will be operational in 2013.

  • Flexibility and New Services

    In addition to adding capacity, CMOs like Lonza are focusing on improving flexibility and offering additional services to their clients.

    “Strengthening our capability, enhancing leading technology, and optimizing operational excellence is our future focus rather than adding new large capacity, as seen in the past three to five years. We are currently undertaking a £16 million investment in the expansion and upgrade of the Slough mammalian production facility that will give us greater flexibility in supporting clinical production,” explains Ming Jeng Chu, head of market intelligence, biopharm.

    Goodwin Biotechnology (GBI) is also expanding its range of services. According to David C. Cunningham, director of business development, “We have expanded our one-stop-shop concept by leveraging collaborations with Macrocyclics, a manufacturer of customized chelating agents, and with Rafagen, a company that develops mammalian cell lines with a proprietary expression system.”

    Another company working to broaden its service offerings is Cytovance Biologics. According to Bill Dull, svp of sales and business development, “We recently closed on a staged $22.5 million equity investment that will fund our equipment, personnel, and facility expansion to meet the growing global client demand for clinical trial and commercial-scale cGMP manufacturing.

    “We are also relocating our laboratories to the once occupied Genzyme Glycobiology Research Institute located in Oklahoma City. This new lab space comes equipped with state-of-the-art analytical and bioprocessing equipment that will allow Cytovance to greatly expand its analytical capabilities such as carbohydrate analysis and protein characterization to better serve the needs of our clients.”

    Meridian Life Sciences will be completing facilities expansion and renovation this year as well. Daniel Shelly, director business development, reports that the expansion includes research, manufacturing, warehouse, and office space expansions.

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