Contract development manufacturing organization (CDMO) MilliporeSigma – the life sciences division of Merck KGaA – will manufacture GMP-compliant dry powder and liquid CCM to support a wide range of biologic modalities including antibodies, vaccines, and cell and gene therapies (CGTs) at the Nantong site.
The production line was designed flexibly to handle different media formulations and customizations. It will be supported by the CDMO’s Shanghai R&D center team dedicated to media development and bioprocess solutions, ensuring a smooth tech transfer.
“Applying media components from qualified sources only, the Nantong GMP facility allows for a smooth transition from pilot to commercial-scale cell culture production with comprehensive regulatory documentation,” a spokesperson for Millipore told BioProcess Insider.
“Along with tailor-made dry powder CCM products, customized technical and operational assistance will also be provided to support local processes and shorten time to market.”
Previously, the GMP custom CCM products were imported into China from other manufacturing sites. The CDMO has three dry powder cell culture media sites that are in Lenexa (Kansas), Irvine (UK), and Nantong (China).
“We provide a full range of innovative solutions to both Chinese and global biopharma customers,” the spokesperson said.
“We have established a raw material management strategy, [ensuring] high-quality, stable raw material supplies, thereby guaranteeing the quality and batch-to-batch consistency of our CCM. With the establishment of the Nantong manufacturing line, customized technical and operational assistance will be provided to local biopharma manufacturers together with custom CCM products, supporting their processes and shortening time to market.”
In July 2023, the firm invested $76 million at its Nantong facility to provide customers with reagents for quality control and testing. In the same month, Millipore invested $25 million to add 98,000 square feet of manufacturing and lab space to its Kansas facility for cell-culture media production.
In December 2023, the firm completed expansion of its China Biologics Testing Center, adding 1,500 square-meter of laboratory space in Shanghai. The firm then made its largest investment to date in the Asia-Pacific (APAC) region, investing over €300 million ($326 million), to construct a bioprocessing production center in Daejeon, South Korea in March 2024. That was followed by an expansion of its global headquarters in Darmstadt, Germany, and the near doubling of capacity at its Schnelldorf, Germany site in June 2024.
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