CMC Biologics and Zymeworks Enter into Agreement for Process Development and Clinical Manufacture of Bi-Specific Antibody Product Candidate - Applied Clinical Trials

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CMC Biologics and Zymeworks Enter into Agreement for Process Development and Clinical Manufacture of Bi-Specific Antibody Product Candidate


CMC Biologics and Zymeworks Enter into Agreement for Process Development and Clinical Manufacture of Bi-Specific Antibody Product Candidate

PR Newswire

SEATTLE and VANCOUVER, British Columbia, Sept. 3, 2014 /PRNewswire/ -- CMC Biologics, Inc., a global leader in process development and contract manufacturing, and Zymeworks Inc., a Canadian biotherapeutics company and a world leader in the development of antibody therapeutics, have entered into a Master Services Agreement for process development, formulation development and cGMP clinical manufacturing of a recombinant human IgG1 bi-specific (heterodimeric) antibody.

CMC Biologics.

"Being selected by Zymeworks, who are known for developing best-in-class and highly effective protein therapeutics, is a natural fit for us and validates our technical excellence and partnering philosophy," said Gustavo Mahler, PhD, Global Chief Operations Officer of CMC Biologics. "Through this agreement, Zymeworks and CMC Biologics will work together to advance the next frontier of bi-specific antibody development platforms and bring novel therapies to patients in need."

"As we advance our lead Azymetric™ oncology program and first therapeutic built on our proprietary ZymeCAD™ platform, choosing a contract partner with a track record of success in development and manufacturing is critical," said Ali Tehrani, PhD, President and CEO of Zymeworks.  "Our collaboration with CMC Biologics helps position us to move our oncology program into clinical trials for the treatment of breast cancer and other solid tumors, as well as subsequent therapeutic candidates targeted towards hematological cancers such as leukemia and lymphoma."

About CMC Biologics
CMC Biologics is leading the industry among CMO's 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 trials and commercial production. The Company's wide range of integrated services includes cell line development, bioprocess development, formulation 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.

About Zymeworks Inc.
Zymeworks is a privately held biotherapeutics company that is developing best-in-class Azymetric™ bi‑specific antibodies and antibody drug conjugates for the treatment of oncology, autoimmunity and inflammatory diseases. The company's novel Azymetric™ and AlbuCORE™ platforms, and its proprietary ZymeCAD™ structure-guided protein engineering technology, enable the development of highly potent bi-specific antibodies and multivalent protein therapeutics targeted across a range of indications. Zymeworks is focused on accelerating its preclinical biotherapeutics pipeline through in-house research and development programs and strategic collaborations. More information on Zymeworks can be found at www.zymeworks.com.

Zymeworks.com

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SOURCE CMC Biologics

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