AGC Biologics to manufacture recombinant protein therapy for Japan’s Teikoku Seiyaku

AGC Biologics, a contract development and manufacturing organization (CDMO) headquartered in Seattle, Washington, has been selected by Teikoku Seiyaku, a Japanese transdermal drug delivery company, to provide microbial contract development and GMP manufacturing services for KTP-001, a recombinant human matrix metalloproteinase-7 being developed to treat lumbar disc herniation.

Under the agreement, initial cell bank creation will take place at AGC Biologics’ microbial center of excellence in Heidelberg, Germany, before transitioning to its Chiba, Japan facility for process development and GMP manufacturing to support clinical trials, according to the announcement.

AGC Biologics said it operates microbial manufacturing facilities across three continents, including sites in Chiba, Japan; Seattle, Washington; Heidelberg, Germany; and Copenhagen, Denmark, which provides supply chain flexibility for drug developers advancing programs from clinical to commercial manufacturing.

“Partnering with AGC Biologics was a clear choice. Their team has a proven track record in microbial manufacturing, and their global presence gives us the flexibility and security we need,” Hiroyuki Kubo, director and executive officer at Teikoku Seiyaku, said in a statement.

“Our role here in Heidelberg is to be a reliable and collaborative partner from the very beginning, applying our microbial development experience to build a robust foundation for this therapy,” Dieter Kramer, general manager of the AGC Biologics Heidelberg site, said in a statement.

The announcement follows several recent developments at AGC Biologics. Earlier this month, the company joined the Orphan Therapeutics Accelerator’s Clinical Development Network as a manufacturing partner to support cell and gene therapy programs for ultra-rare diseases, building on its existing work as a manufacturer of an FDA-approved gene therapy.

AGC Biologics also recently expanded its manufacturing agreement with Novelty Nobility to advance a bispecific antibody candidate through GMP manufacturing at its Chiba facility.