According to the agreement, the contract development and manufacturing organizations (CDMOs) will offer a “gene to vial” value chain service with a single contract and project management team, expected to save time and resources for developers.
“Our gene to vial value chain means you can come to AGC Bio and get everything you need for your drug product, from pre-clinical work and process development, through manufacturing, quality, and analytical services, to drug substance release and the aseptic filling of your drug product,” a spokesperson for AGC Bio told BioProcess Insider.
“The BioConnection collaboration is a critical part. They have a historic track-record of success and regulatory expertise in aseptic filling of vials and syringes and liquid products. This helps to enhance AGC Bio’s services and give partners everything they need in one offering.”
For Seattle, Washington-based AGC Bio, this partnership is part of a long-term vision to meet increased demand. In 2023, the CDMO expanded its sites in Heidelberg, Germany, Milan, Italy, and Longmont, Colorado. A biologics facility in Copenhagen, Denmark is also close to completion.
“We are also beginning construction in Yokohama, Japan that will offer global companies a new high-tech facility that can meet their needs. This gives us the flexibility to take on more projects to meet demands at once, now with full drug product services via this new partnership,” the spokesperson told us.
Furthermore, the impact of the BIOSECURE Act on the pharmaceutical industry feels significant, said the firm. Introduced in January 2024, the revised act gives US biopharma firms until 2032 to sever ties with Chinese “companies of concern.”
“Drugmakers of all sizes are reviewing their outsourcing supply chains following proposed US federal legislation that looks to put distance with companies that are being labeled as potential national security concerns. We are giving the industry a comprehensive solution leveraging ‘like for like’ single-use technology using common bioreactors from Cytiva, and Thermo Fisher,” the spokesperson said.
This partnership aims to address the ongoing needs of the industry in the wake of the proposed Act, offering services for development, manufacturing (including freeze-drying) and aseptic filling that use only US and European-based facilities.
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