New Pharmaceutical Auxiliary Materials cGMP standard introduced for cell culture media manufacturing
Merck first in the industry to receive EXCiPACT Certification
Merck’s cell culture media production sites certified in Germany, UK, China, and USA

Merck, a leading science and technology company, 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.

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Cell culture media 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. (Photo: Business Wire)

“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.

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.

Merck provides a full range of innovative solutions to local and global biopharma customers. In addition to CCM, the Life Science business offers an extensive range of products, including cell lines, bioreactors, filters, resins, chromatographic, pharmaceutical raw materials, and excipients. Its end-to-end process solutions are designed to comprehensively support biopharma manufacturers from process development to scale-up, benefiting patients and contributing to the advancement of global health.

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About Merck

Merck, a leading science and technology company, operates across life science, healthcare and electronics. Around 63,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2023, Merck generated sales of € 21 billion in 65 countries.

Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as MilliporeSigma in life science, EMD Serono in healthcare, and EMD Electronics in electronics.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240903134063/en/

Media Relations
Rachel Bloom Baglin
rachel.bloom-baglin@merckgroup.com
Phone: +49 (6151) 72-44461

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