New Standard for Pharmaceutical Auxiliary Materials (PAMs) Set
Merck, a leading global science and technology company, has achieved a pioneering milestone by becoming the first in the industry to receive EXCiPACT certification for its Cell Culture Media (CCM) production sites. This certification is a significant advancement in the field of pharmaceutical auxiliary materials, setting a new standard for current Good Manufacturing Practice (cGMP) in the manufacturing of non-sterile excipients.
Certification Across Multiple Global Sites
The prestigious EXCiPACT certification has been granted to Merck’s major CCM production facilities located in Germany, the UK, China, and the USA. This certification validates Merck’s commitment to maintaining the highest standards of quality, safety, and efficacy in its production processes. The EXCiPACT standard, introduced in May 2023, specifically addresses the cGMP requirements for cell culture media, a crucial component in the production of life-saving therapies.
Importance of Cell Culture Media
Cell culture media are essential raw materials used extensively in the biopharmaceutical industry. They play a critical role in processes such as vaccine production, gene therapy, and the manufacture of monoclonal antibodies. These media provide the necessary environment for cell growth and production, making their quality and consistency vital for the success of biomanufacturing processes. Merck’s achievement of EXCiPACT certification underscores its dedication to delivering high-quality, reliable cell culture media to its customers.
Statement from Merck
Ivan Donzelot, Head of Integrated Supply Chain Operations for Merck’s Life Science business, expressed pride in achieving this certification. “We are honoured to be the first cell culture media manufacturer audited and certified to the new EXCiPACT GMP Guideline. This standard is critical to assuring the safety, quality, and efficacy of cell culture media used in drug components. It also highlights the value Merck brings to its life science customers,” Donzelot stated.
EXCiPACT Certification Scheme
EXCiPACT is a non-profit organisation that manages the Certification Scheme for pharmaceutical excipient manufacturers and distributors globally. The new cGMP standard for Cell Culture Media, created in partnership with Merck, establishes a new industry benchmark for quality and excellence. The certification process entailed comprehensive evaluations to verify adherence to the new standard, further affirming Merck’s superior performance in this domain.
Merck’s Comprehensive Solutions
In addition to its certified CCM, Merck’s Life Science business offers a broad range of innovative products and solutions. These include cell lines, bioreactors, filters, resins, chromatographic materials, pharmaceutical raw materials, and excipients. Merck provides end-to-end process solutions that support biopharma manufacturers throughout process development, scale-up, and production. This all encompassing approach enhances patient outcomes and plays a crucial role in advancing global health.
Progression
Merck’s achievement marks a notable progression in the field of pharmaceutical auxiliary materials. The company remains committed to advancing its manufacturing processes and delivering high-quality products that meet the evolving needs of the biopharmaceutical industry. With this new certification, Merck solidifies its position as a leader in the production of cell culture media and other critical components in the life science sector.
