Cytovance Biologics currently specializes in the execution of clinical production of antibody and recombinant protein products derived from cell culture at scales up to 1,000L (w/v) from batch, fed-batch and perfusion processes and microbial production up to the 100L scale. The 1,000L and 5,000L bioreactors will complement the existing manufacturing process trains that include 100L, 500L and 1,000L bioreactors, 100L wave system, 20L and 200L Sartorius subs and a 100L microbial manufacturing train. The new bioreactors will be operational by the end of 2013 or early 2014.
Cytovance currently offers semi-automated aseptic vial fill/finish. With the addition of the Chase-Logeman fill/finish system, the increased capabilities will support vial sizes from 2mL to 100mL, batch sizes ranging from a few hundred vials to 20,000 or more and includes 100% weight check. The automated fill/finish service line will meet all FDA and EU regulatory requirements and is scheduled to be fully operational in the third quarter of 2013.
"To meet market and customer demands, we have decided to expand our capabilities in 2013 with the larger bioreactor and fill/finish automation," commented Darren Head, Cytovance President & CEO. "The increase in capabilities will allow Cytovance to provide clinical material to key clients as they move though the clinic and into commercial."
Cytovance continues to provide analytical method development and process development for phase I, II, and III clinical trial materials as well as regulatory expertise to support validation and commercial market launch for therapeutic proteins, recombinant proteins and monoclonal antibodies.