Nucleus Biologics Becomes First Custom Cell Culture Media Company to Achieve EXCiPACT Certification for the Manufacture of Excipient GMP Quality Cell Culture Media, Supplements, and Buffers

SAN DIEGO, Jan. 9, 2025 /PRNewswire/ - Nucleus Biologics, a leader in precision cell culture media development, is proud to announce that it has achieved an industry-leading quality milestone. It has received EXCiPACT certification for Pharmaceutical Excipients and Pharmaceutical Auxiliary Materials (PAMs) and ISO 9001 certification from SGS. This Excipient GMP certification will better support the cell culture media, buffers, reagents, and supplements needs for our cell and gene therapy customers. This certification, in addition to our 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.

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). 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.

"Every cell and gene therapy will require excipients in the final drug product. Receiving the EXCiPACT certification demonstrates our commitment to quality and leadership in the industry to meet the highest regulatory standards demanded by our cell and gene therapy customers for our media, buffers, and supplements. We recognize that our customers require unique formulations, with higher quality and lower cost to facilitate patient access to life-saving cell and gene therapies," said David Sheehan, CEO at Nucleus Biologics. "Excipient GMP quality manufacturing enables our customers to manufacture fully custom media, buffers, and supplements as excipients to scale their cell and gene therapy programs with confidence, knowing that their cell culture solutions meet the highest global regulatory standards."

"Nucleus Biologics' quality management system underwent a thorough assessment by SGS ensuring it passed the most rigorous standards to ensure it aligned with key industry stakeholders' expectations for quality in manufacturing", stated Supreeya Sansawat, SGS Vice President, Life Sciences. "They are to be congratulated on this achievement".

The Importance of GMP Manufacturing of Excipients in Cell and Gene Therapies

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.

For more information about Nucleus Biologics and its Excipient GMP solutions, please visit www.nucleusbiologics.com.

About Nucleus Biologics

Nucleus Biologics is the leading provider of custom cell-growth media and buffer solutions, tools, and technologies for cell and gene therapy. Its mission is to speed the time from scientific discovery to cure by delivering innovative, transparent, and GMP products and services. From design to delivery, we offer an entire digital ecosystem of cell culture solutions that seamlessly interface with one another, facilitating easy formulation, configuration, ordering, and electronic batch record enabled manufacture of media and buffers, while addressing the environmental impacts of cell culture fulfillment.

SOURCE Nucleus Biologics