COPENHAGEN, Denmark and SEATTLE, Nov. 9, 2011 /PRNewswire/ -- Single-use technologies are widely accepted in the biomanufacturing of biological therapeutics and vaccines. Pharma/biopharmaceutical companies, contract manufacturing organizations, engineering firms, and leading technology suppliers are embracing advances in disposable technologies. Over 120 delegates from the biomanufacturing industry attended a two-day ‘Single-Use Technology Seminar’ in Copenhagen on 25-26th October. The event was co-sponsored by CMC Biologics, Thermo Fisher Scientific, Applikon Biotechnology, and BioProcess International. Process developers, scientists, engineers and operations professionals met to knowledge-share the practical and theoretical aspects of latest single-use systems, including the new 2,000 liter Thermo Scientific HyClone Single-Use Bioreactor (2,000L SUB) for large-scale cGMP manufacturing.
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At a facility tour and reception held at CMC Biologics’ facility in Copenhagen, seminar attendees had an opportunity to view the newly installed disposable bioreactor the first operational HyClone 2,000L SUB in Europe. According to David Wolton, Vice President, Manufacturing, CMC Biologics, “I truly believe that the new 2,000L SUB is an industry game changer. In-market supply using large scale disposable reactors is now within limits, and CMC Biologics is on the forefront cGMP single-use production in both Europe and the United States.”
“This seminar has been a testament to how far the single-use industry has advanced over the last several years,” said Cory Stevenson, Vice President and General Manager of Thermo Fisher Scientific’s BioProcess Production business. “Large biotech companies are increasingly embracing single-use technology in cGMP production, and they are achieving significant cost and time savings on the one hand and comparable cell growth on the other hand.”
The Single-Use Technology Seminar agenda included presentations by industry leaders David Wolton, CMC Biologics; Ruchika Bandekar, MedImmune Ltd.; Sebastiaan Hoekema, Merck Animal Health Boxmeer; Justin Hutchinson, Thermo Fisher Scientific; Christian Loeffelholz, ZurichUniversity of Applied Sciences; Iann Rance, Ph.D., Cytheris; Eric Unrau, CRB Engineering; and Wilfried Wohrer, Baxter Innovations GmbH.
“Limitations, including time-consuming set up and limited volume range, coupled with increasing demand triggered an evaluation of SUBs for material supply,” noted Ruchika Bandekar, Research and Development, MedImmune in her presentation. “The comparison demonstrated consistent performance and product quality across all vessels at all scales, allowing interchangeable use of reactors, resulting in increased throughput, flexibility, and more efficiency in scheduling.”
About CMC Biologics
CMC Biologics (www.cmcbio.com) is a dedicated contract biopharmaceutical manufacturing and development organization with facilities in Copenhagen, Denmark and Seattle, Washington, USA. CMC Biologics specializes in custom services for scale up and cGMP manufacture of protein-based therapeutics for preclinical, clinical trials, and in-market production. The Company’s fully integrated services includes cell line development using its proprietary CHEF1® system, process and formulation development, and comprehensive analytical testing. CMC Biologics has fully segregated microbial fermentation and mammalian cell culture suites and offers stirred tank and perfusion production processes.
SOURCE CMC Biologics
