Introducing itself for the first time at BIO-Europe 2015 in Munich, Shanghai CPGJ uniquely holds the largest monoclonal antibody production capacity in China and has been awarded four national high-tech industrialization enterprises. Shanghai CP GuoJian Pharmaceutical Company looks forward to meeting potential partners for strategic alliances in target markets, especially the Chinese market, for innovative products and opportunity, e.g., CMO based on CPGJ CMC and world class 40,000L bio reactor. It is committed to the advanced management of quality compliance, cost effective operation and IP protection, which benefits every external client in the long term.
Jerry Zhang, Vice President, Shanghai CPGJ Pharma
CPGJ has accumulated more than 12 years of regulatory experience in China for submitting Investigational New Drugs (INDs) and Biologic License Applications (BLAs). We have launched two products in emerging markets, including China. Nine research projects are currently underway in therapeutic areas that include autoimmune diseases and oncology.
Shanghai CP GuoJian Pharmaceutical Company today employs more than 1,200 people. CPGJ has built one of largest research and development centers in China for monoclonal antibodies with more than 200 professional researchers of whom 20% hold post-doctoral or doctoral degrees. The company holds the distinction of being the only national enterprise technology center for antibody drugs in China and provides professional support for the national intellectual property strategy in the field of biopharmaceuticals. Many scientists have been working for MNC in their careers.
Research teams are divided between the CPGJ Biological Research Institute and the Center of Medical & Translational Sciences, giving the company capabilities in all development stages from upstream to downstream, covering fundamental research, discovery, cell engineering, cell line, pilot production, formulation, analysis and intellectual property. Among the professionals in the Center of Medical & Translational Sciences, 45% hold doctoral or master’s degrees with expertise in preclinical safety , clinical pharmacology, translational medicine and registration.
Quality Management at Shanghai CPGJ is both comprehensive and rigorous, and it not only leads domestic industry standards, but is the lead actor in establishing biopharmaceutical industry quality standards in China. The production environment meets the highest standards of Good Manufacturing Practices (GMP) and the company annually has accepted as many as four plant audits and GMP inspections from different countries. The Quality by Design method applied by CPGJ establishes a comprehensive quality management system covering the continuum of product processes that begins from the earliest project approval to the very end of a product life cycle.