- AGC Biologics has been selected by Teikoku Seiyaku to provide microbial development and GMP manufacturing services for KTP-001, a recombinant human matrix metalloproteinase-7 therapy for lumbar disc herniation.
- The program will utilize AGC Biologics’ facilities in Heidelberg, Germany, and Chiba, Japan, for cell bank creation, process development, and clinical trial manufacturing.
AGC Biologics has entered a contract development and manufacturing agreement with Teikoku Seiyaku Co., Ltd. to support development and GMP manufacturing activities for KTP-001, a recombinant human matrix metalloproteinase-7 (rhMMP-7) therapy being developed for lumbar disc herniation.
Under the agreement, initial cell bank creation activities will be conducted at AGC Biologics’ Microbial Center of Excellence in Heidelberg, Germany. The project will then transition to the company’s Chiba, Japan facility for process development and GMP manufacturing to support clinical trials.
Teikoku Seiyaku stated that it selected AGC Biologics based on the company’s microbial manufacturing expertise and global manufacturing network. AGC Biologics noted that the partnership will leverage its microbial manufacturing operations across Europe, Asia, and North America to provide development flexibility and supply chain continuity throughout clinical and potential commercial stages.
“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.”
Dr. Hiroyuki Kubo, Director and Executive Officer at Teikoku Seiyaku
AGC Biologics stated that the agreement further expands its CDMO and contract manufacturing activities in microbial biologics development. The company said its microbial manufacturing network includes facilities in Japan, the United States, Germany, and Denmark, supporting drug developers through clinical and commercial manufacturing stages.