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The biopharmaceutical market demands reliable and flexible manufacturing technology to meet high volume production, low manufacturing costs, and adherence to the stringent safety requirements set by international regulatory authorities.
The PER.C6® cell line offers a reliable, safe and scalable solution for the production of recombinant therapeutic proteins and monoclonal antibodies. Non-human protein glycosylation, produced by rodent cells or hybridomas has been linked in several instances to accelerated in vivo protein clearance, leading to reduced therapeutic efficacy in humans. The PER.C6® cell line, being of human origin, provides recombinant proteins with human-type glycosylation. These features of the PER.C6® technology bring the development and manufacturing of therapeutic proteins to a higher level.
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Crucell has a panel of unique DNA expression vectors that can be transfected into PER.C6® cells to generate stable and high yielding cell lines. The cell line generation program from DNA to high expressing cell clone takes less than 6 months to allow rapid proof of concept studies. Typical yields of recombinant proteins, including complex fusion proteins, produced on PER.C6® cells are almost tenfold higher than other tested mammalian cell platforms.
Using Crucell’s unique XD process, high yields of biologically functional antibody have been achieved with over 10 gram/liter. The XD process is a new production process that makes use of the unique ability of the PER.C6® cell line to grow to extremely high densities of up to 150 million cells/ml.
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Crucell offers cell line development programs generating high yielding, stable PER.C6® cell lines. This service, which typically takes 3 to 6 months from start to finish, allows companies a quick start in pre-clinical and clinical product development with established PER.C6® cell lines. Products can be manufactured in the PER.C6® cell line under serum-free conditions in formats ranging from roller bottles to perfusion bioreactors. In December 2002, Crucell formed an alliance with DSM Biologics to expand manufacturing services. This alliance offers the total package from cell line generation up through Phase I and II GMP manufacturing at 250 liter scale within 12 months.
In November 2006, the Crucell and DSM Biologics alliance opened the PER.C6® Development Center in Cambridge, Mass. PERCIVIA is involved in research in the use of PER.C6® cells as a technology platform for large-scale production of recombinant therapeutic proteins. PERCIVIA provides technology transfer and technical support to the users of the PER.C6® platform worldwide. For further information, visit www.percivia.com.
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