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Oct 1, 2008 (Vol. 28, No. 17)

CMOs See Robust Growth

Contract Manufacturing Organizations Are Cautiously Optimistic about 2009

  • Downstream Processing

    CMOs are not only expanding cell-culture and fermentation tank capacity, but they are also expanding their downstream processing capabilities and capacities. Many CMOs are also expanding their process-development expertise and offering new expression systems.

    At Avecia, Dr. Taylor noted, “We have significantly extended our offering in a number of support services to offer a more complete service to meet our clients’ needs. These include stability and formulation development. We have also invested over $2 million in new state-of-the-art, development laboratory space to support our pAVEway ™ offering.”

    Avecia’s pAVEway system is a protein production platform that offers clients high expression levels. In addition to improved expression systems, Avecia has made significant investments in downstream operations and supply-chain management systems.

    “For our late-phase and commercial clients, we have invested multiple millions of dollars this year to add large-scale reversed phase chromatography, enhanced centrifugation capabilities, plus improved supply-chain management systems,” Dr. Taylor concluded.

    In June, DSM Biologics reported that it had achieved record yields in producing IgG antibodies using PER.C6® technology. By employing the PER.C6 human cell line and XD™ technology, DSM achieved titers of 27 grams per liter. In addition, they are expanding capacity and investing in further process-optimization technologies, noted King.

    “We have recently added two 250 L disposable bioreactors to our facility, and we will add 50 L cGMP capacity for our high-yielding XD technology by the end of this year. We plan to make further investments such as 250 L cGMP capacity for our XD technology and also 1,000 L cGMP fed-batch.”

    Cobra Biomanufacturing continues to expand its Oxford facility for the commercial manufacture of GenVec’s TNFerage™ product, which is currently in various clinical trials for pancreatic, rectal cancer, melanoma, and head and neck cancer. “Cobra is currently investing approximately $2.5 million in upgrading our Oxford facility for commercial manufacture of TNFerade in 2009,” Saxby stated.

    Cobra is also investing in disposable bioreactor and bioprocessing technologies at its Keele facility. In July, the firm extended its manufacturing agreement with ViroMed to include a long-term research, development, and technical consultancy agreement for all ViroMed’s products.

  • New Locations and Collaborations

    This year, three CMOs have announced cross-border manufacturing collaborations and expansions. Early in the year, CMC Biologics purchased the Seattle-based operations of ICOS Biologics from Eli Lilly. In August, the firm inked a deal with Symphogen under which CMC will develop processes and manufacture polyclonal antibody product candidates for Symphogen.

    In June 2008, Eden Biodesign announced formation of a U.S. subsidiary, Eden Biodesign. “This new operation will offer cell-line and strain-development services with supporting process and analytical development, and facilitate development of stable, highly productive production lines,” said Roger Lias, president at Eden Biodesign.

    Eden Biodesign also recently announced a collaboration agreement with Human Genome Sciences that “provides HGS with access to our global marketing and business development reach and, in turn, provides our mammalian cell culture clients with the opportunity to access world-class cGMP production capacity at large scales up to 20,000 L working volume,” stated Dr. Lias.

    Also in June, PacificGMP and Pacific Biopharma Group signed a definitive merger agreement and will develop a cGMP joint venture in Taizhou, China. The new joint venture, China Quantitative Biomedicine, will be one of the largest single-use biomanufacturing facilities in the U.S. or China, according to the firms.

    The biopharmaceutical contract manufacturing market continues to experience year-over-year growth. Overall, the industry is on target to meet their growth plans in 2008, although most biopharmaceutical contract manufacturers expect slightly lower growth in 2009. Contract manufacturers continue to invest in new capacity, expand service offerings, and develop new technologies to meet their clients’ needs, including expanded capacity, capabilities, and services.

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