Catalent expands its bioreactor capacity

The US biopharma outsourcing services company said the expansion will more than double its present bioreactor capacity by 2009, with the addition of a 1,000 litre bioreactor train in its Middleton, Wisconsin facility. The firm indicated that the capacity expansion is in response to "increased client demand for production to support clinical trials across Asia, Australia, Europe and now the United States​". As the biopharmaceutical industry matures aand more and more biologic drugs are moving through research and development pipelines, new opportunities are being created for contract manufacturers that engage in biopharmaceutical production, such as Catalent. The manufacturing of biopharmaceuticals is an expensive, complex, and highly technical process in comparison to that of small molecules and investment in manufacturing capacity for biopharmaceuticals is a risky decision for most companies as product development timelines are lengthy and have a high probability of failure. Catalent uses its proprietary GPEx technology to assist companies in the development of new biopharmaceuticals. The firm said it does so in a "compliant, timely and cost-effective manner​," as the GPEx system produces stable, high-yielding mammalian cell lines for protein production "more quickly and efficiently than competing technologies​". The company has so far generated over 150 cell lines for production of recombinant proteins and antibodies, one of which is now being used to manufacture a biosimilar product, and others which have been used in clinical trials on three continents. Moreover, Catalent said it has also now supplied two biotech companies with GPEx-produced proteins that are currently being used in the US in clinical trials for the purpose of filing a investigational new drug (IND) application with the Food and Drug Administration (FDA).