Installs a 1,000L SUB bioreactor, 5,000L stainless steel bioreactor and fill/finish line
Cytovance Biologics, a US-based contract manufacturer of mammalian and microbial biologics, is to expand its mammalian production capabilities to include a 1,000L SUB bioreactor, a 5,000L stainless steel bioreactor and an automated fill/finish line.
The Oklahoma, US-based biopharmaceuticals manufacturer specialises in the 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 new 1,000L and 5,000L bioreactors will complement process trains that include 100L, 500L and 1,000L bioreactors, 100L wave system, 20L and 200L Sartorius subs and a 100L microbial manufacturing train. They will be operational by the end of the year, or early in 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 fill/finish line will meet FDA and EU regulatory requirements and is scheduled to be fully operational in the third quarter of 2013.
‘The increase in capabilities will allow Cytovance to provide clinical material to key clients as they move though the clinic and into commercial,’ said Darren Head, President and CEO of Cytovance.
Cytovance continues to provide analytical method development and process development for Phase I, II and III clinical trial materials. The company also has regulatory expertise to support validation and commercial market launch for therapeutic proteins, recombinant proteins and monoclonal antibodies.