GRONINGEN and LEIDEN, Netherlands and PARSIPPANY, N.J., Sept. 29 /PRNewswire/ -- DSM Biologics and Crucell N.V. (Euronext, Nasdaq: CRXL; Swiss Exchange: CRX) announced today that the high-titer fed-batch process developed at the PERCIVIA PER.C6(R) Development Center, their joint venture in Cambridge, USA was recently scaled up to 250 liters by DSM Biologics scientists at their GMP facility in Groningen, The Netherlands. They successfully achieved 8 grams per liter for an IgG expressed by PER.C6(R) cells using chemically defined cell culture medium in a SUB (single-use bioreactor).
This result confirms a reliable, versatile and commercially feasible production platform to manufacture large amounts of therapeutic proteins with ease and economic affordability. Also, this latest result, using conventional fed-batch process, adds to the previous achievements of 27 grams per liter -- biomass corrected -- using DSM's XD(TM) technology, and demonstrating a reliable performance of the PER.C6(R) cell line under such production conditions.
Marco Cacciuttolo, CEO and President of PERCIVIA, comments that, "This new development further strengthens our commitment to modernize therapeutic protein manufacturing. The successful scale up of the high-titer fed-batch process means that the PER.C6(R) platform can be easily and quickly implemented into commercial facilities with no retrofit requirements. We continue to be very pleased and enthused by the ease of use, the reproducibility, and the overall robustness of the platform."
About PER.C6(R) Technology
Crucell's PER.C6(R) technology platform has been developed for the large-scale manufacture of biopharmaceutical products such as recombinant proteins including monoclonal antibodies. Compared to conventional production technologies, the strengths of PER.C6(R) technology lie in its excellent safety profile, scalability and productivity under serum-free culture conditions.
About XD(TM) techn
|SOURCE DSM Pharmaceutical Products|
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