Far Eastern Federal University (FEFU) has announced plans to establish a comprehensive infrastructure for the development and commercialization of biotech products. Within the next two years, the university aims to launch a contract GMP manufacturing site and a certified GLP vivarium, addressing the critical shortage of R&D capabilities in the domestic market.
Key Takeaways:
- Institution: Far Eastern Federal University (FEFU).
- Timeline: Launch expected within 2 years.
- Facilities: Pilot GMP manufacturing plant & GLP vivarium.
- Core Competencies: CDMO services, API production, Preclinical trials for regulatory submission.
Bridging Science and Commercial Market
The new pilot facility is designed to solve scalability issues for biotech innovations. According to Lyudmila Tekutieva, Director of the Advanced Engineering School at FEFU, the initiative aims to create a seamless transition from laboratory research to commercial distribution.
The future GMP site will focus on:
- Process development and scaling for biopharmaceuticals.
- Production of active pharmaceutical ingredients (APIs).
- Contract Development and Manufacturing (CDMO) services for external partners.
- Training students in real-world industrial environments.
GxP Compliance and Regulatory Strategy
A key component of the project is the establishment of a GLP-compliant vivarium. Certification under Good Laboratory Practice (GLP) standards ensures that data generated at the facility will be valid for regulatory filings.
| Product Category | Activity | Regulatory Body Acceptance |
|---|---|---|
| Pharmaceuticals | Preclinical trials | Ministry of Health (Minzdrav) |
| Supplements & Functional Food | Safety & Efficacy testing | Rospotrebnadzor |
The ability to issue legitimate protocols directly from the university hub will significantly accelerate market entry for new molecules and functional products, eliminating the need for redundant third-party testing.
Source: TASS
