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Oct 1, 2010 (Vol. 30, No. 17)

CMOs Invest Time & Money to Improve Their Operations

Contract Manufacturers Bank on New Initiatives to Boost Capabilities

  • Business Outlook and Opportunities

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    Quality is the top-ranked criteria for CMO selection, according to HighTech Business Decisions' "Biopharmaceutical Contract Manufacturing Report: Expanding Markets, New Capacities and Improved Performance."

    In addition to expanding its quality capabilities, the CMO industry continues to invest in capacity expansions. The CMOs interviewed for this article were generally optimistic about their business prospects.

    Overall, CMOs are expecting revenue growth in the range of 25% to 30% from 2010 to 2011. This growth expectation comes largely from a combination of capacity expansion, increased demand for novel vaccine and biologic manufacturing, and expanded service offerings.

    In April, Cytovance Biologics was awarded a biopharmaceutical development and manufacturing contract by Selexys Pharmaceutical for its Anti-PSGL-1 therapeutic agent. Cytovance is undertaking facility and personnel expansion to meet current and anticipated demand from customers. It has added a 1,000 L bioreactor to augment its 100 L and 500 L mammalian production suite and is expanding the bioanalytical laboratory and process development space.

    Over the next 18 months, Cytovance is planning to expand its microbial manufacturing and aseptic fill-and-finish capabilities as well as add a 5,000 L bioreactor. According to Bill Dull, vp of sales and business development, “this strategy to increase manufacturing capacity and services is a direct result of current customers partnering with us to move beyond clinical-stage production and meet their commercial-scale manufacturing needs.”

    In August, CMC Icos Biologics reported the completion of a new state-of-the-art disposables manufacturing facility at its Seattle site. The addition comes as part of a staged major expansion plan, which will add significant production capacity to its existing facility to accommodate growing demand for cGMP manufacture of biopharmaceuticals.

    “CMC’s expanded service offerings include analytical and formulation services as well as the development of unique solutions for clients through various combinations of our expression platform, cell-line development, proprietary medium, and analytical services, including evenly matched upstream and downstream scales in our new single-use disposable bioreactor facilities,” he added.

    Meridian Life Science reports seeing a great deal of interest especially in novel vaccine preparations like virus-like particles (VPL) made in a baculovirus insect cell expression system, gene therapy vectors, and even traditional vaccine preparations. Recent projects have included a dual VLP vaccine, recombinant Dengue and RSV vaccines, and a live oral rotavirus vaccine.

    As CMOs respond to government and financial pressures by implementing quality and efficiency measures, they see benefits in the bottom line and other fronts. Novel conjugated biologics, though challenging to manufacture, provide yet another opportunity for niche players that can develop an expertise in this new arena. Expanded facility and service offerings are a response to customer demand and will drive revenue growth.

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