- Merck has received the EXCiPACT cGMP certification for Pharmaceutical Auxiliary Materials (PAMs) at its global Cell Culture Media (CCM) production sites.
- This marks the first time a company in the industry has achieved this certification, covering sites in Germany, the UK, China, and the USA.
Merck, has been awarded the EXCiPACT cGMP (current Good Manufacturing Practice) certification for Pharmaceutical Auxiliary Materials (PAMs) across its global Cell Culture Media (CCM) production sites. This certification is significant as it marks the first time a company in the industry has achieved this level of compliance with the newly established standard.
The EXCiPACT cGMP certification is a globally recognized standard for the manufacturing of non-sterile excipients, which are crucial components in the production of pharmaceuticals. The certification applies to Merck’s sites located in Darmstadt, Germany; Irvine, United Kingdom; Nantong, China; St. Louis, USA; and Lenexa, USA. These sites play a key role in the production of CCM, a vital raw material used in various biomanufacturing processes, including vaccine production, gene therapy, and the manufacturing of monoclonal antibodies.
Merck’s achievement follows the publication of the new PAMs cGMP standard for CCM manufacturing in May 2023. The certification reflects Merck’s commitment to maintaining the highest standards in the production of cell culture media, ensuring the quality, safety, and efficacy of these critical components in drug development and production.
“We are honored to be the first cell culture media manufacturer audited and certified to the new EXCiPACT GMP Guideline,” said Ivan Donzelot, Head of Integrated Supply Chain Operations for Merck’s Life Science business. He emphasized the importance of this standard in assuring the quality of cell culture media used in therapeutic applications, reinforcing Merck’s dedication to its life science customers.
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