My colleague Trevor Calkins, director of process development and manufacturing, wrote a nice article in the latest (Sept) issue of BioProcess International on the manufacturing and handling of high potency APIs. Trevor is located at our HP-API facility in Madison, WI.
As Trevor points out, HP-APIs are a key component in the manufacture of antibody drug conjugates (ADCs). With the increasing success of Seattle Genetics SGN-35 for Hodgkin's disease and Roche's T-DM1 for the treatment of breast cancer, ADCs are expected to play a larger and largers role in the pipelines of companies developing new oncology drugs. SAFC has invested heavily in two state-of-the art manufacturing facilities for HP-APIs - both in WI - and serves as a key outsourcing option for the manufacturing of HP-APIs and ADCs.
Trevor's article discusses the challenges and capabilites that a manufacturer must have to handle these difficult products. He describes engineering controls and personnel training/protection embodied in the Madison and Verona facilities that allow safe manufacture of these key compounds under GMP conditions - in these multipurpose facilities. (Link to isolator photo inside Madison facility).
Pharma magazine also has coverage on SAFC HPAPI expansion plans.
Posted by Bruce Lehr October 3rd 2010.