Merck Secures Industry First Excipact Certification for Cell Culture Media Manufacturing

Landmark Move Merck Secures Industry First Excipact Certification for Cell Culture Media Manufacturing

2024-09-30 Source: Press release Merck 1 min Reading Time

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Merck has received this certification for Pharmaceutical Auxiliary Materials and it is claimed to be the first company in the industry to receive this certification. Excipact is a widely recognized standard for the manufacturing of non-sterile excipients.

Merck has achieved Excipact cGMP certification for Pharmaceutical Auxiliary Materials at its major global Cell Culture Media production sites. (Source: Merck) — Merck has achieved Excipact cGMP certification for Pharmaceutical Auxiliary Materials at its major global Cell Culture Media production sites.
(Source: Merck)

Darmstadt/Germany – Merck has achieved Excipact cGMP (current Good Manufacturing Practice) certification for Pharmaceutical Auxiliary Materials (PAMs) at its major global Cell Culture Media (CCM) production sites. Excipact is a widely recognized standard for the manufacturing of non-sterile excipients. The company is the first in the industry to receive this certification.

“We are honored to be the first cell culture media manufacturer audited and certified to the new Excipact GMP Guideline. 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 Merck brings to its life science customers,” said Ivan Donzelot, Head of Integrated Supply Chain Operations for the Life Science business of Merck.

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CCM is an essential raw material used in the manufacture of life-saving therapies and in processes as varied as vaccine manufacturing, gene therapy, and monoclonal antibody manufacturing. Because of its central role in biomanufacturing, a consistent supply of high-quality media is required to deliver the necessary concentration and protein quality for therapeutics.

Excipact is a non-profit organization that owns and manages the Certification Scheme available to pharmaceutical excipient manufacturers and distributors worldwide. Together with Merck, it developed the industry-first cGMP standard for Cell Culture Media. The new PAMs cGMP standard for CCM manufacturing was published in May 2023. Certified Merck sites are located in Darmstadt, Germany; Irvine, United Kingdom; Nantong, China; St. Louis, USA and Lenexa, USA.

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