GMP Cytokine and Growth Factor Manufacturing Facility for Cell Therapy
Cell and gene therapies represent some of the most revolutionary medical treatments today. At Bio-Techne, our mission is to deliver innovative solutions that enable cell and gene therapies to reach more patients. We have invested in building our new manufacturing facility because we recognize the growing demand for larger quantities of critical cytokines.
Choosing a partner that can grow with you is a crucial component in the pathway to success. R&D Systems, a Bio-Techne brand, has a rich history of producing the most widely used proteins in the world. Our expertise in protein development and manufacturing, combined with stringent quality control and experienced regulatory support, allows us to offer industry-leading GMP proteins for cell therapy manufacturing.
Our new state of the art GMP manufacturing facility was built with cell therapies in mind. It is entirely animal-free and has large-scale bioreactors with room for expansion, backed by experienced manufacturing, quality, and regulatory teams. Watch the video to learn more about our GMP capabilities.
Key Features of Our New Facility
- Entire facility dedicated to manufacturing GMP proteins
- Animal-free facility – No animal components are allowed in the facility
- Capacity – 61,000 sq. ft. to meet your supply requirements now and in the future
- Expandability – Available space to add additional capacity
- ISO 5/7/8 cleanrooms for the entire production process
Certifications and Regulatory Guidelines Followed in the GMP Manufacturing Facility
- USP Chapter <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
- USP Chapter <92>, Growth Factors and Cytokines Used in Cell Therapy Manufacturing
- Ph. Eur. General Chapter 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products
Not finding what you need? Speak with a Cell & Gene Therapy Specialist and let us know exactly what GMP raw materials will fit your process.