MilliporeSigma, a Contract Development Manufacturing Organization (CDMO) and the life sciences sector of Merck KGaA, will produce GMP-compliant dry powder and liquid CCM at the Nantong site to assist with various biologic modalities like antibodies, vaccines, and cell and gene therapies (CGTs).

The assembly line was created to be adaptable for various types of media compositions and modifications. The CDMO's Shanghai R&D center team will provide support for media development and bioprocess solutions to facilitate a seamless 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 sources.

“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.”

In the past, GMP custom CCM products were brought into China from other production locations. The CDMO operates three facilities for dry powder cell culture media located 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.”