Merck, a global leader in science and technology, has earned EXCiPACT cGMP (current Good Manufacturing Practice) certification for Pharmaceutical Auxiliary Materials (PAMs) at its major Cell Culture Media (CCM) production facilities worldwide. This certification, a highly regarded industry standard for the production of non-sterile excipients, makes Merck the first company in the sector to achieve this milestone.
“We are proud to be the first cell culture media manufacturer to undergo and receive certification under the new EXCiPACT GMP Guideline. This standard is essential to ensure the safety, quality, and efficacy of cell culture media used in drug development, and it reflects the value Merck brings to its life science customers,” said Ivan Donzelot, Head of Integrated Supply Chain Operations for Merck’s Life Science division.
Cell Culture Media (CCM) is a vital raw material in the production of life-saving therapies, including vaccines, gene therapies, and monoclonal antibodies. Its critical role in biomanufacturing demands a reliable supply of high-quality media to maintain the required protein concentration and quality in therapeutics.
EXCiPACT, a non-profit organization overseeing certification for pharmaceutical excipient manufacturers and distributors globally, collaborated with Merck to develop the first cGMP standard for Cell Culture Media. The PAMs cGMP standard for CCM manufacturing was introduced in May 2023. Merck’s certified sites are located in Darmstadt, Germany; Irvine, United Kingdom; Nantong, China; St. Louis, USA; and Lenexa, USA.
In addition to Cell Culture Media, Merck’s Life Science division offers a comprehensive range of products and services for biopharma companies, including cell lines, bioreactors, filters, resins, and pharmaceutical raw materials. Its end-to-end solutions are designed to support biopharma manufacturers from process development through to full-scale production, ultimately benefiting patients and advancing global health.
