Peking University Biologics
Pharmaceuticals - , Shang Hai Shi, China
Peking University Biologics Employees
Peking University Biologics Senior Management
Peking University Biologics Details
Peking University Biologics is a one-stop biopharmaceutical CDMO professional organization with many years of biopharmaceutical scale-up, optimization, and technology transfer experience focusing on biologic drugs from gene development to CMC preparation, IND application, commercial manufacturing, BLA to commercialization. In 2021, we were the first leading biologics CDMO company to obtain the "Drug Manufacturing License" in Anhui Province, awarded the "Anhui Quality Credit AAA Demonstration Enterprise" and awarded the title of Hefei City's "Japan Cooperation and Exchange Base" of the "One Belt, One Road" Alliance for Technology Industry Innovation. As one of the largest biologics CDMO manufacturing sites in China (over 400,000 m2 of the production facility and infrastructure), we also have R&D technical centers in Hong Kong and Xiamen to support China-based biotech and biopharmaceutical companies to enter the international market. Our management team has accumulated years of experience in drug development, GMP production, and regulatory experience (NMPA, FDA, EMA, PMDA, TGA, MedSafe, etc.) to help drug development companies fulfill regulatory requirements.At the same time, we work with CRO companies in New Zealand and Australia for start-up projects from drug development, validation, CMC preparation, IND application, production of clinical samples to conducting Phase I clinical trials in New Zealand and Australia so as to increase the value for customers' projects at low cost and within a short period to achieve international standards (GMP specification) and project internationalization.To increase the cost-effectiveness for customers' projects, Peking University Biologics is your "Biologics Ambassador" to the international biopharmaceutical market!
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