DSM and Crucell announce record achievement in PER.C6® technology

DSM Biologics and Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) today announce another breakthrough in the production of IgG antibodies using PER.C6® technology. By employing the PER.C6® human cell line and proprietary XD™ technology, a record yield of over 27 grams per liter has been achieved. In March 2008 a yield of 15 grams per liter was reported.

This milestone is the new manufacturing paradigm for mammalian cell culture to produce protein products effectively, where the industry has struggled to date with low yields and unstable platforms. This record surpasses all other production systems including those previously set by PER.C6® technology itself.

The use of PER.C6® technology will clearly impact cost of goods for marketed products and reduce the risk of premature high capital expenditures. Higher yields mean smaller footprints for facilities, reduced risk in drug development, higher utilization of facilities and better chance of success. Drugs that would otherwise not be brought to market because they are too expensive to produce, may now find a vehicle for commercialization. More so, the glycosylation of monoclonal antibodies and proteins, produced using PER.C6® technology, is fully human.

Scientists at the PERCIVIA PER.C6® development center, a joint venture between DSM and Crucell, have shown that they can reproducibly manufacture a record amount of product with over 95% viability and unchanged product quality. This accomplishment was achieved using standard bioreactor equipment and readily available cell culture medium. The result of this effort provides the entire biotechnology industry with a reliable production platform to economically manufacture large amounts of therapeutic proteins with ease.

Marco Cacciuttolo, CEO and President of PERCIVIA, says: “This new achievement surpasses all other reported titer levels to date with any mammalian system and clearly demonstrates the robustness and power of the PER.C6® platform. We are particularly enthused with the user-friendliness of the platform and pleased to be able to provide this to our licensees. We strive to revolutionize the pharmaceutical industry in protein production.”

Marcel Lubben, Vice President, Marketing, Sales and Business Development at DSM Biologics, adds: “We are extremely pleased with this achievement. This milestone coincides with our commitment to provide the most inherently robust manufacturing platform and ensure the utmost product quality for protein manufacturing. Our mission of only the best quality for manufacturing is echoed by the PER.C6® technology platform.”

“The PER.C6® Manufacturing Platform once again demonstrates itself as the most robust commercial system available today combining ease of use, and plug and play essentials, for any standard equipment, with little optimization requirements” states Martina Molsbergen, VP Business Development PER.C6® Licensing, Crucell. “Companies are rapidly embracing the PER.C6® technology as the true commercially viable tool for protein manufacturing. More so, the COGS savings to be realized for companies employing the PER.C6® platform are compelling enough to offset risks in drug development.”