AGC Biologics Partners with Teikoku Seiyaku for Novel rhMMP-7 Therapy Manufacturing to Treat Lumbar Disc Herniation
核心洞察
AGC Biologics has been selected by Teikoku Seiyaku to provide microbial contract development and manufacturing services for KTP-001, a recombinant human matrix metalloproteinase-7 (搜索) therapy targeting lumbar disc herniation (搜索).
The partnership leverages AGC Biologics' global network with initial cell bank creation in Heidelberg, Germany, followed by process development and GMP manufacturing in Chiba, Japan for clinical trials.
This collaboration highlights AGC Biologics' unique position as the only CDMO offering microbial manufacturing across three continents, providing supply chain security and flexibility for drug developers.
AGC Biologics has been selected by Teikoku Seiyaku Co., Ltd. to provide microbial contract development and manufacturing services for KTP-001, a recombinant human matrix metalloproteinase-7 (搜索) (rhMMP-7 (搜索)) therapy designed to treat lumbar disc herniation (搜索). The partnership represents a significant step forward in developing a potentially less invasive treatment option for patients with this common spinal condition.
Strategic Manufacturing Partnership
Under the agreement announced on May 26, 2026, AGC Biologics will leverage its global manufacturing network to support the development of KTP-001. Initial cell bank creation activities will take place at AGC Biologics' Microbial Center of Excellence in Heidelberg, Germany, before transitioning to the company's facility in Chiba, Japan, for process development and GMP manufacturing to support clinical trials.
"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."
Global Manufacturing Network Advantage
The partnership highlights AGC Biologics' unique position as the only contract development and manufacturing organization (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.
"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."
Innovative Therapeutic Approach
KTP-001 represents an innovative approach to treating lumbar disc herniation (搜索) through the use of recombinant human matrix metalloproteinase-7 (搜索). Teikoku Seiyaku, founded in 1848 and dedicated to its mission "For a World Without Pain," brings extensive expertise in transdermal absorption technology to the partnership.
"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.
Manufacturing Capacity and Investment
AGC Biologics has been strategically investing to meet future microbial demand. The company has brought a new microbial line online in the U.S. to support reshoring initiatives and is offering innovative capacity reservation models at its Heidelberg site in 10,000 L scale to provide long-term security for late-phase and commercial products. This is in addition to the extensive, established capabilities at its Copenhagen and Chiba sites, ensuring partners have access to robust, global capacity now and in the future.
The global network provides crucial flexibility and de-risks the supply chain by offering geopolitical stability and redundancy of supply. It allows for efficient tech transfer between sites with harmonized quality systems, offers multi-continent production options to meet regional market demands, and ensures business continuity.