Polypeptide Project Lifecycle Compliance Consulting Services

Project Background：

The client is a renowned enterprise in the biotech sector, specializing in the research, development, and production of polypeptide drugs. With a strong R&D team and advanced production facilities, the company achieved milestone innovations in antimicrobial peptides, antitumor peptides, and synthetic biology. Over the years, the client has provided exceptional technical and product services to outstanding scientists, prestigious research institutions, and enterprises across mainland China, Europe, and the United States. The client's newly built polypeptide facility compliant with China, U.S., and EU standards requires design review, quality system enhancement consulting, and qualification and validation consulting services.

AUSTAR Solution：

AUSTAR provided the client with validation and consulting services compliant with Chinese, U.S., and EU GMP requirements throughout the entire lifecycle of the polypeptide drug project, including:

• Review of detailed design drawing GMP compliance

• Quality system enhancement consulting

• Qualification and validation consulting services (covering utility systems, bulk production workshops, QC laboratories, pilot workshops, and stem cell workshops)

• Process-related validation, including procedural methods, process validation, cleaning validation, packaging validation, etc.

AUSTAR Value & Client Benefits：

• The project meets the requirements of NMPA GMP, EU GMP, and FDA cGMP, referencing standards and guidelines such as ISPE, PDA, ICH, WHO, and ISO.

• As a company transitioning from R&D-focused operations, the client achieved collaborative growth and progress through close teamwork. AUSTAR not only assisted the client in resolving immediate project challenges but also emphasized the transfer of knowledge and skills, enhancing the client's team expertise and capabilities in GMP and validation compliance.