Installation at Copenhagen plant expected to be ready for GMP contract manufacturing by the end of the year
Contract biopharmaceutical manufacturing and development organisation CMC Biologics has completed the installation of a 2,000-litre single-use bioreactor (SUB) at its manufacturing facility in Copenhagen. The Thermo Scientific HyClone SUB will begin shake-down runs and is expected to be ready for GMP contract manufacturing by December 2011.
According to Dr Gustavo F. Mahler, global chief operations officer of CMC Biologics, the expansion of the facility to include the 2,000L SUB will allow the company to meet increasing demand for producing biologicals for Phase III and into market supply.
‘The advantages for CMC Biologics and our customers are clear: reduced project times, reduced risk of cross-contamination resulting in increased process reliability and reduced batch manufacturing costs that will allow CMC Biologics to be even more competitive,’ he said. ‘We have worked closely with Thermo Fisher Scientific to bring this project in on time and on budget.’
‘With CMC Biologics’ leadership in contract biopharmaceutical manufacturing and applying single-use systems, it is not surprising that our first 2,000L SUB in Europe is being installed at their Danish facility,’ stated Brandon Pence, global director of marketing, cell culture and bioproduction, Thermo Fisher Scientific.
A Single-Use Technology Seminar, co-sponsored by Applikon Biotechnology, BioProcess International, CMC Biologics, and Thermo Fisher Scientific, is to be held on 25–26 October 2011 at the Clarion Hotel in Copenhagen, Denmark, and will provide an opportunity to view the 2,000L SUB at CMC Biologics' facility.