Catalent Pharma Solutions reports that that Cerenis Therapeutics, a biopharmaceutical company, has advanced its lead clinical candidate, CER-001, into Phase III clinical studies across Europe and North America. Cerenis Therapeutics' CER-001 candidate is an engineered complex of recombinant human apoA-I, the major structural protein of high-density lipoprotein (HDL) and phospholipids. The development of CER-001 has used Catalent's proprietary GPEx technology, which creates mammalian cell lines.

To date, six GPEx based antibody and protein products are approved and marketed and 34 therapeutic candidates are currently in the clinic on a global basis. Catalent performs GPEx programs at its biomanufacturing facility in Madison, Wisconsin, which was completed in June 2013. Designed for cGMP production from 10 L up to 1,000 L, and non-GMP production up to 250 L, the site features single-use technologies and unidirectional flow.

Source: Catalent Pharma Solutions