Cytovance Biologics will expand its current mammalian production capabilities to include a 1,000L single-use bioreactor (SUB), a 5,000L stainless steel bioreactor, and an automated fill/finish line. The new bioreactors expand the company’s existing manufacturing process trains, which include 100L, 500L and 1,000L bioreactors, a 100L wave system, 20L and 200L Sartorius SUBs and a 100L microbial manufacturing train. They will be operational by the end of 2013 or early 2014.
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.
“To meet market and customer demands, we have decided to expand our capabilities in 2013 with the larger bioreactor and fill/finish automation,” said Darren Head, Cytovance president and chief executive officer. “The increase in capabilities will allow Cytovance to provide clinical material to key clients as they move though the clinic and into commercial.”