AGC Biologics to develop and manufacture KTP-001 (rhMMP-7) for Teikoku Pharma
- AGC Biologics will provide microbial-based process development and GMP-compliant drug substance manufacturing for KTP-001 (recombinant human MMP‑7).
- KTP-001 is designed for direct intradiscal administration to support spontaneous regression of herniated lumbar disc tissue.
- A cell bank established at AGC Biologics’ Heidelberg site will be transferred to its Chiba site for process development and clinical manufacturing.
- Manufacturing output is intended for clinical trial use and leverages AGC Biologics’ integrated global GMP platform across Japan, the US and Europe.
Agreement scope
AGC Biologics will provide development and manufacturing services for the drug substance of KTP-001, a protein-based therapeutic candidate (recombinant human matrix metalloproteinase-7) under development by Teikoku Pharma for lumbar disc herniation.
Technical plan
The service package covers microbial-based process development and GMP-compliant drug substance manufacturing to produce material for clinical trials.
Site operations
As part of the project, a cell bank established at AGC Biologics’ Heidelberg, Germany site will be transferred to its Chiba, Japan site, where process development and GMP manufacturing for clinical use will be performed.
Strategic context
AGC Biologics operates an integrated global GMP system across Japan, the United States and Europe and continues to expand its CDMO capabilities across modalities to support customers from early-stage development through commercial production.
Source: AGC