International pharmaceutical excipients certification body EXCiPACT has granted MilliporeSigma GMP certification for PAM manufacturing, which applies to the company’s major global cell-culture media (CCM) production sites in Germany, UK, China, and the US.

MilliporeSigma is the first company to receive PAM certification for the 2023 standard outlined in EXCiPACT’s Application of EXCiPACT GMP Standard to Pharmaceutical Auxiliary Materials.

“We are honored to be the first cell culture media manufacturer audited and certified to the new EXCiPACT cGMP Guideline,” said Ivan Donzelot, head of integrated supply chain operations, Life Science business of Merck KGaA, Darmstadt, Germany. “This standard is critical to assure the safety, quality, and efficacy of cell-culture media in the use of drug components and a testament of the value we bring to our life science customers.”

The new standard for CCM was codeveloped by EXCiPACT and Merck KGaA with acknowledged contributions from many other industry stakeholders, including representatives from large companies such as Eli Lilly, Thermo Fisher Scientific, Sanofi, and GSK.

“Our head of regulatory orchestrated a pivotal moment in the project when he convinced the President of EXCiPACT that there was a gap in the industry where customers expected to see GMP being applied but there was no actual guideline,” Eoin Weldon, head of communications UK and Ireland, Life Sciences at Merck, said to BioProcess Insider. “We had three people who volunteered as part of the committee assembled to write the new guidelines. They offered their subject matter expertise to help develop the bioburden-reduction sections of the PAMs guideline.”

EXCiPACT’s standards for pharmaceutical excipient suppliers are widely recognized by the industry, with more than 200 companies being recognized on its websites for having achieved certifications. For example, Merck KGaA has a pair of certificates for its Darmstadt, Germany and Nantong, China sites for  manufacturing excipients. Certified suppliers are required to make their EXCiPACT audit reports available to manufacturers.

“Last year, we announced a €23 million ($25.5 million) expansion of our Lenexa, Kansas site to increase our cell culture media manufacturing capabilities,” said Weldon. “Additionally, we recently broke ground on our new €300 million ($333 million) bioprocessing production center in Daejeon, South Korea, that will provide essential biotech products including cell culture media. This certification demonstrates our continued commitment to meeting current and future demand for high-quality cell culture media and is a testament to the value that we bring our customers.”