Biotechnology

Recommendation for Leachables Studies - Standardized cell culture test for the early identification of critical films

Today, single-use technology is used routinely in biopharmaceutical development and manufacturing processes. Besides many advantages, the available single-use systems still have limitations. One of the most cited disadvantages is the risk for release of potentially toxic or inhibitory substances, so-called leachables from the plastic bags. The bags are typically made of multi-layer thermoplastic films. Until now, no standardized cell culture test was available to identify critical bag films at an early stage in process development. To meet this need, a sub-team of the DECHEMA temporary working group "Single-Use Technology in Biopharmaceutical Manufacturing" developed a standardized cell culture test that would enable the early identification of non-satisfactory films for cultivation of CHO cell lines in chemically defined culture media.

Report Of The Temporary Working Group: Single-use Technology in Biopharmaceutical Production

En Route to the Knowledge-Based Bio-Economy - Cologne-Paper

Renowned experts from academia and industry were invited to contribute to an expert paper which outlines the perspectives of a KBBE within the next 20 years. The resulting so-called 'Cologne Paper' was published on 30 May 2007 in Cologne on behalf of the German Presidency of the Council of the European Union.