GMP Cytokine and Growth Factor Manufacturing 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 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
Current Products Available from the Saint Paul GMP Facility
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.
Frequently Asked Questions about our GMP Facility
Security of Supply & Scalability
Bio-Techne’s new GMP manufacturing facility can ensure the security of supply for GMP proteins due to the expanded manufacturing capacity and enhanced ability to scale. The facility is designed to supply customers with raw materials for commercial manufacture, ensuring the availability of qualified raw materials from clinical stage to therapeutic commercialization.
Transitioning from Pre-Clinical to GMP Grade
This facility is a dedicated animal-free manufacturing space, meaning no animal components are allowed in the facility to minimize risk and ensure product consistency. The pre-clinical and GMP proteins manufactured in this facility undergo the same manufacturing process in animal-free conditions to facilitate your transition from pre-clinical to GMP grade proteins. Manufacturing the different grades in the same manner eases your transition from pre-clinical to GMP by reducing the variability of the product’s performance, ultimately enabling you to get to the clinic sooner.
Bio-Techne has a strict definition of animal-free: No animal-containing materials are used anywhere in the manufacturing process or facility, and no equipment has ever been exposed to animal products. Our animal-free proteins share the same biological activities as those produced for our standard research grade, easing the transition between protein formats. We obtain animal-free Certificates of Origin from raw material suppliers and Certificates of Origin are available for each protein upon request.
Read more about our animal-free manufacturing conditions here.
4. I’m looking for a sizing, vialing, or labelling option that isn’t listed on the website. Can I request a custom option?
Bio-Techne understands that having reagents that fit seamlessly into your process can save money and reduce manufacturing risk. Please contact our Custom Services Team to discuss your needs and whether custom solutions are available. Available options include:
- Liquid fill
- Custom pack sizes
- Vialing based on mass and activity
- RUO to GMP conversion