#USA #San Diego #Nucleus Biologics #EXCiPACT #GMP Quality

Nucleus Biologics Achieves EXCiPACT Certification for Cell Culture Media

Nucleus Biologics, an innovator in precision cell culture media development, has reached a remarkable quality benchmark by securing EXCiPACT certification. This certification emphasizes their commitment to superior manufacturing standards for cell culture media, buffers, and supplements specifically designed for cell and gene therapy applications.

The recent certification enhances Nucleus Biologics’ reputation in the biopharmaceutical industry, as they become one of the select few cell culture media manufacturers globally to obtain this prestigious mark. Along with ISO 9001 certification from SGS, Nucleus is poised to support the evolving needs of biopharmaceutical businesses that rely on high-quality excipients for their therapies.

Why EXCiPACT Certification Matters

EXCiPACT certification is an internationally recognized standard aimed at ensuring that excipient manufacturers consistently maintain good manufacturing practices (GMP). In practical terms, this certification means Nucleus Biologics has undergone rigorous assessments to validate their quality systems and manufacturing process controls. Achieving this status signals their ability to supply cell culture products that meet the highest safety, efficacy, and compliance standards—critical for developers of cell and gene therapies.

As David Sheehan, CEO of Nucleus Biologics, stated, "The excipients included in every cell and gene therapy product necessitate stringent regulatory standards. This certification is a testament to our unwavering commitment to quality in an increasingly competitive market."

Supporting Advanced Therapeutics

The significance of excipient GMP quality media in therapy development cannot be overstated. These products ensure that the results from cell culture processes are consistent, safe, and scalable, facilitating everything from research and development to clinical and commercial production.

For developers focused on cell and gene therapies, working with EXCiPACT certified products ensures a smoother pathway for regulatory approvals and market access. This translates into accelerated timelines for getting life-saving therapies to patients, ultimately impacting public health positively.

As noted by Supreeya Sansawat, Vice President of Life Sciences at SGS, "Nucleus Biologics has demonstrated exceptional quality management practices. This achievement positions them as a reliable partner in the life sciences sector."

A Vision for the Future

With its groundbreaking excipient GMP solutions, Nucleus Biologics aspires to empower researchers and developers alike by enabling them to manufacture fully customized media and supplements. This capability provides reassurance that their cell culture solutions meet or exceed global regulatory standards.

In summary, Nucleus Biologics has laid a robust foundation for innovation in cell culture solutions. By achieving EXCiPACT certification, they are not only solidifying their leadership position in the industry but also paving the way for more effective management of cell and gene therapies. The insights and advancements stemming from this achievement will undoubtedly contribute to the rapid development of groundbreaking therapeutics needed in today’s healthcare landscape.

For those interested in learning more about Nucleus Biologics and their extensive range of excipient GMP solutions, additional information is available at www.nucleusbiologics.com.