Diosynth Information

Executive Summary Diosynth Biotechnology is a global Contract Manufacturing Organization (CMO) specializing in current Good Manufacturing Practices (cGMP) Biopharmaceutical production. Service to the Biotechnology Industry: 10 plus years in the CMO business Completed over 80 projects Our customers rely on our: Experience manufacturing clinical and commercial products On-time delivery Scientific know-how Our goal is and has always been to help our customers succeed in what matters most…ultimately delivering the drug to the patient. Through our support in CMC development, biotechnology companies have been assured of dedicated manufacturing services that meets industry requirements in speed, quality and yield. We have provided manufacturing solutions for: •Proteins developed in Mammalian cell culture systems •E. coli and Pichia fermentation processes •Baculovirus-based insect cell culture technology …And we have done so for multiple classes of molecules including: •Monoclonal Antibodies (MAbs) •Recombinant enzymes •Hormones •Fusion-proteins From process to product Services include: •Analytical method development, qualification, and validation •Analytical testing •Quality systems •Technology transfer •Fill and finish Putting quality first Our commitment to quality covers all aspects of our business practices. We operate under a Quality Management System that assures that all active pharmaceutical ingredients (APIs) produced meet industry standards and all applicable regulatory requirements of the United States, European Union and Japan. Our facilities have been inspected by the US Food and Drug Administration (FDA) and by the European Agency for Evaluation of Medicinal Products (EMEA). Specialties CMO, Biotech