AGC Biologics, your friendly CDMO expert, was selected by Teikoku Seiyaku Co., Ltd., a leader in transdermal drug delivery, to provide microbial contract development and manufacturing services for KTP-001, a recombinant human matrix metalloproteinase-7 (rhMMP-7), to treat lumbar disc herniation. 

“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,” said Dr. Hiroyuki Kubo, Director and Executive Officer at Teikoku Seiyaku. “We value their collaborative spirit and working together will be instrumental in bringing this important new therapy to patients.”

Development and GMP manufacturing for clinical trials

Under the agreement, AGC Biologics will leverage its global network, with initial cell bank creation activities taking place at its Microbial Center of Excellence in Heidelberg, Germany. The project will then transition to the AGC Biologics’ facility in Chiba, Japan, for process development and GMP manufacturing to support clinical trials.

“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,” said Dieter Kramer, General Manager of the AGC Biologics Heidelberg site. “We have a 40-year-long tradition of helping projects advance and are well accustomed to partnering with other sites in our network to provide a steady journey towards GMP manufacturing.”

“We are delighted to support the Teikoku Seiyaku team on such an innovative project. It’s a privilege to support their vision for a therapy that could offer a new, less invasive option for patients,” said Susumu Zen-In, General Manager of the AGC Biologics Chiba site.

A CDMO with a stable, global network

This partnership highlights AGC Biologics’ unique position as the only CDMO offering microbial manufacturing on three continents— Asia (Chiba, Japan), North America (Seattle, USA), and Europe (Heidelberg, Germany and Copenhagen, Denmark). This global network provides supply chain security and flexibility, allowing drug developers to de-risk their journey from clinical to commercial stages in a shifting geopolitical landscape.