🧬 This agreement focuses on GMP production of viral vectors. It will aid advanced therapy development targeting serious diseases.
🔬 Matica will manage technology transfer, process scale-up, and testing, supporting the Biologics License Application submission.
🏭 CEO Paul Kim emphasized their expertise in delivering regulatory-compliant therapeutic products.
Introduction:
Matica Biotechnology, a Contract Development and Manufacturing Organization (CDMO) focused on viral vector production for cell and gene therapies, has announced a strategic partnership with a U.S.-based clinical-stage biotech company to advance the manufacturing of a novel therapy. This collaboration highlights a significant step in the realm of advanced therapeutic development.
- Matica Biotechnology has signed a commercial manufacturing agreement with a U.S. biotech firm, focusing on the production of viral vectors for gene therapy.
- The agreement encompasses technology transfer, process scale-up, analytical testing, and commercial-scale Good Manufacturing Practice (GMP) production services.
- Matica Bio aims to support Biologics License Application (BLA) submissions as well as future commercial supply of the new therapeutic product.
- Paul Kim, CEO of Matica Bio, emphasized the company’s capability to support the entire lifecycle of advanced therapeutic development, ensuring regulatory compliance.
- Matica Bio’s proprietary technologies, including the MatiMaxTM cell line and advanced analytical capabilities, are positioned to meet the challenges of complex cell and gene therapy programs.
Conclusion:
The collaboration between Matica Biotechnology and the U.S. biotech company marks an important advancement in the production of viral vectors for gene therapy. With a comprehensive approach that combines process development and regulatory readiness, Matica Bio is poised to facilitate the successful progression of innovative therapies aimed at addressing unmet medical needs. This partnership underscores the importance of strategic collaborations in the evolving landscape of biopharma development.
