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.