CMC Biologics has an agreement with CSL Behring for the manufacture of the first intermediate of recombinant factor VIII single-chain drug substance. CMC Biologics' facility in Copenhagen, Denmark was inspected by the FDA as part of the approval for the commercial manufacture of AFSTYLA®.
"We are extremely pleased to help CSL Behring provide this critical treatment option to patients for management of hemophilia A," said Gustavo Mahler, PhD, President & Chief Executive Officer of CMC Biologics. "With marketed products manufactured in both our Seattle and Copenhagen facilities, we provide robust commercial solutions and experience for our clients on both continents. Our commitment to deliver on our client's products is prioritized across the entire organization."
About CMC Biologics
CMC Biologics is leading the industry among CDMOs in reliability, technical excellence, and quality — Right and On Time. With three facilities in the USA and Europe, the Company provides fully integrated biopharmaceutical development and manufacturing solutions to clients globally. The Company has proven expertise in delivering custom solutions for the scale-up and cGMP manufacture of protein-based therapeutics for pre-clinical, clinical, and commercial production. The Company's wide range of integrated services includes cell line development, bioprocess development, formulation development, and comprehensive analytical testing. Clients can also benefit from CMC Biologics' proprietary CHEF1® expression system for mammalian production. CMC Biologics has fully segregated microbial fermentation and mammalian cell culture suites and offers both fed-batch and perfusion production processes. More detailed information can be found at www.cmcbiologics.com.
Robert Broeze, PhD, SVP, Global Business Development, CMC Biologics, +1 (609) 273-3414
AFSTYLA® [Antihemophilic Factor (Recombinant), Single Chain] and any and all CSL Behring's brand, products, services and feature names, logos, and slogans are trademarks or registered trademarks of CSL Behring or its subsidiaries in the United States or other countries. All rights reserved.
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SOURCE CMC Biologics