Abstract
Background For the production of recombinant proteins, a human cell-derived expression technology can offer significant advantages with respect to protein quality, serum halflife and safety. High volumetric productivity with firstclass quality is the ultimate ambition during process development. CEVEC’s proprietary expression system based on human amniocytes offers significant advantages for the production of complex human proteins and antibodies. The key benefits are the stable and high expression of recombinant proteins with human type posttranslational modifications, the robust growth behaviour with competitive high cell densities and the easy handling in serum free suspension. CAP cells meet all regulatory requirements, they are of non-tumour origin and from an ethically accepted source. In order to test the performance of CAP cells for the production of very complex proteins, stable C1-inhibitor expressing CAP cells were developed. C1-inhibitor is a serine protease inhibitor (serpin) and one of the most heavily glycosylated plasma proteins bearing numerous complex Nand O-glycans.
Highlights
For the production of recombinant proteins, a human cell-derived expression technology can offer significant advantages with respect to protein quality, serum halflife and safety
Subsequent process development was carried out with one clone showing the best performance in growth and expression
Glutamine, pyruvate, soy peptone, tryptone plus, tryptone or an inhouse mixture of R3-IGF, transferrin, SyntheChol and progesterone were added to the base medium
Summary
For the production of recombinant proteins, a human cell-derived expression technology can offer significant advantages with respect to protein quality, serum halflife and safety. High volumetric productivity with firstclass quality is the ultimate ambition during process development. CEVEC’s proprietary expression system based on human amniocytes offers significant advantages for the production of complex human proteins and antibodies. The key benefits are the stable and high expression of recombinant proteins with human type posttranslational modifications, the robust growth behaviour with competitive high cell densities and the easy handling in serum free suspension. In order to test the performance of CAP cells for the production of very complex proteins, stable C1-inhibitor expressing CAP cells were developed. C1-inhibitor is a serine protease inhibitor (serpin) and one of the most heavily glycosylated plasma proteins bearing numerous complex N- and O-glycans
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