CMC Biologics and MacroGenics Enter into Process Validation and Clinical Manufacturing Agreement for Commercialization of Next-Generation Oncology Product Candidate

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Jun 17, 2014, 07:00 ET

SEATTLE, June 17, 2014 /PRNewswire/ -- CMC Biologics, Inc., a global leader in process development and contract manufacturing, and MacroGenics, Inc. (Nasdaq:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer and autoimmune diseases, have entered into a Master Services Agreement for process validation activities and clinical manufacturing of another of MacroGenics' oncology product candidates.

"Last month, the companies entered into an initial agreement to further develop the production process for transfer and clinical manufacturing of an immuno-oncology product candidate; and we are thrilled to be selected as the CMO of choice by MacroGenics for development and manufacture of an additional oncology product candidate," said Gustavo Mahler, PhD, Global Chief Operations Officer of CMC Biologics. "This contract further underscores our technical competence in process development and manufacture of projects destined for commercial success."

"We continue to be impressed with CMC Biologics' technical competencies and customer focused project management philosophy," said MacroGenics President and Chief Executive Officer, Scott Koenig, MD, PhD. "Choosing a contract manufacturing partner with demonstrated process characterization and validation capabilities to meet our clinical and commercial timelines is critical to realizing the potential of breakthrough biologics and life-saving medicines."

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.

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