Nucleus Biologics, a cell culture media development provider, 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 cell and gene therapy customers. This certification, in addition to our ISO 13485 certification, supports the highest quality products that meet 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). The certification validates the company’s quality systems, process controls, and dedication to supporting the 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 cell culture media, buffers, and reagents are vital components in the development and manufacture of advanced therapeutics. These products are designed to ensure precise and reproducible results to meet regulatory demands; reduced risk of contamination from raw materials; and seamless transition from R&D to clinical and commercial production.