DSM and UMN sign manufacturing deal
manufacturing deal with Japanese UMN Pharma based on the firm's
novel recombinant protein manufacturing platform.
Under the terms of the agreement, the contract manufacturer will provide UMN with full process and analytical development services and cGMP manufacturing batches for its recombinant fusion protein, UMN-03, using DSM's PER.C6 cell line platform. UMN-03 is a myostatin-inhibiting fusion protein aimed at the treatment of muscular dystrophy and metabolic diseases such as obesity and type II diabetes mellitus. After finishing the manufacture of the clinical sample, the clinical study will be started in 2008, UMN said. Dutch company DSM has co-exclusive rights, along with another Dutch biotech company, Crucell, to license the high-producing PER.C6 human cell line as a production platform for recombinant proteins and monoclonal antibodies. The PER.C6 technology uses cell culture for the large-scale production of recombinant proteins and monoclonal antibodies, including influenza vaccine, where the virus is grown on specially selected cell lines instead of chicken eggs. The strengths of the PER.C6 technology lie in its safety profile, scalability and productivity under serum-free culture conditions. This cell culture process has the potential to reduce from four weeks to two or three weeks the start-up time for manufacturing and could result in a more predictable manufacturing process. This latest agreement builds further on the PER.C6 license agreement that was signed in March between UMN Pharma, DSM Biologics and Crucell. "The protein market is growing rapidly and may reach $200bn (€157bn) in 15 to 20 years and we believe that PER.C6 has the potential to become the technology of choice for an attractive part of that market," said Leendert Staal, president of DSM pharmaceutical products. The services will be provided out of DSM Biologics' FDA-approved manufacturing facility in Groningen, Netherlands.
