Nucleus Biologics awarded excipient GMP certification for cell culturing products

The excipient GMP certification, in addition to the ISO 13485 certification, underscores Nucleus Biologics’ commitment to delivering the highest quality products that meet the most stringent safety, consistency, and compliance requirements of the biopharmaceutical industry.

Nucleus Biologics is only the second cell culture media manufacturer and the only West Coast USA and custom supplier to be certified to EXCiPACT for PAMs. Achieving this certification validates the company’s robust quality systems, process controls, and dedication to supporting the rapidly growing cell and gene therapy sectors.

EXCiPACT is an internationally recognized certification standard specifically designed for excipient manufacturers. It ensures that facilities adhere to the highest standards of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).

Excipient GMP quality cell culture media, buffers, and reagents are vital components in the development and manufacture of advanced therapeutics.

These products ensure:

• Consistency: Precise and reproducible results to meet regulatory demands.
• Safety: Reduced risk of contamination from raw materials.
• Scalability: Seamless transition from R&D to clinical and commercial production.

For cell and gene therapy developers, excipient GMP certification of Nucleus Biologics’ cell culture media, buffer, and supplement manufacturing provides a critical pathway to de-risking their manufacturing processes while accelerating regulatory approvals and market access.

By achieving EXCiPACT certification, Nucleus Biologics positions itself as a trusted partner for the development of advanced therapeutics. The certification complements its broader mission of delivering precision cell culture solutions that empower scientists to bring life-saving therapies to market faster.

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