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
| Protein (Human) | Source | Catalog # GMP Animal-Free | Catalog # Preclinical Animal-Free |
| IL-7 | E.coli | BT-007-GMP | BT-007-AFL |
| IL-10 | E.coli | 1064-GMP | |
| IL-15 | E.coli | BT-015-GMP | BT-015-AFL coming soon |
Bio-Techne believes in the power of partnerships. We have joined with Fresenius Kabi and Wilson Wolf to bring you ScaleReady™, lowering the barriers to entry into the immune cell therapy space for all sizes and stages of manufacturing programs. ScaleReady brings cell and gene therapies to life by offering a significant reduction of complexity and cost while consistently providing superior repeatability and cell quality.
The ScaleReady product portfolio supports scalable immune cell therapy solutions using GMP IL-2, IL-7, IL-15, and IL-21, delivering true platform, process, and product continuity for your immune cell programs. When paired with the Lovo® and Cue® functionally-closed-system automated cell processing systems, Bio-Techne reagents and the G‑Rex® Bioreactor enable high throughput parallel processing of cell therapies within a small footprint.
Analysis of the Activity, Lot-to-Lot Consistency, and Purity of GMP-grade Recombinant Human IL-2
(A) Three independent lots of GMP-grade Recombinant Human IL-2 (R&D Systems, Catalog # BT-002-GMP) were tested for their ability to stimulate proliferation of CTLL-2 mouse cytotoxic T cells. The ED50 for this effect is 0.03-0.25 ng/mL. Each trace on the graph represents data obtained from GMP-grade Recombinant Human IL-2 from a different manufacturing run, demonstrating the lot-to-lot consistency of the protein. (B, C) The purity of the three independent lots of GMP-grade Recombinant Human IL-2 shown in part A were assessed by CE-SDS on Maurice (ProteinSimple, Catalog # 090-000) under reducing (R; part B) and non-reducing (NR; part C) conditions and visualized in Compass for iCE software. The gel views obtained from the Compass software are shown.
Analysis of the Activity, Lot-to-Lot Consistency, and Purity of GMP-grade Recombinant Human IL-7
(A) Three independent lots of GMP-grade Recombinant Human IL-7 (R&D Systems, Catalog # BT-007-GMP) were tested for their ability to stimulate proliferation of PHA-activated human peripheral blood lymphocytes. The ED50 for this effect is 0.1-0.5 ng/mL. Each trace on the graph represents data obtained from GMP-grade Recombinant Human IL-7 from a different manufacturing run, demonstrating the lot-to-lot consistency of the protein. (B, C) The purity of the three independent lots of GMP-grade Recombinant Human IL-7 shown in part A were assessed by CE-SDS on Maurice (ProteinSimple, Catalog # 090-000) under reducing (R; part B) and non-reducing (NR; part C) conditions and visualized in Compass for iCE software. The gel views obtained from the Compass software are shown. The IS band is a 10 kDa Maurice CE-SDS Internal Standard Marker (ProteinSimple, Catalog # 046-144) that was added to each sample to calculate the relative migration time (RMT).
Analysis of the Activity, Lot-to-Lot Consistency, and Purity of GMP-grade Recombinant Human IL-10
(A) Three independent lots of GMP-grade Recombinant Human IL-10 (R&D Systems, Catalog # 1064-GMP) were tested for their ability to stimulate proliferation of MC/9-2 mouse mast cells. The ED50 for this effect is 0.0750-0.750 ng/mL. Each trace on the graph represents data obtained from GMP-grade Recombinant Human IL-10 from a different manufacturing run, demonstrating the lot-to-lot consistency of the protein. (B, C) The purity of the three independent lots of GMP-grade Recombinant Human IL-10 shown in part A were assessed by CE-SDS on Maurice (ProteinSimple, Catalog # 090-000) under reducing (R; part B) and non-reducing (NR; part C) conditions and visualized in Compass for iCE software. The gel views obtained from the Compass software are shown. The IS band is a 10 kDa Maurice CE-SDS Internal Standard Marker (ProteinSimple, Catalog # 046-144) that was added to each sample to calculate the relative migration time (RMT).
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.
We can work with you to provide different lots for testing and share historical activity data, when available. Contact Us to discuss your testing needs.
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.
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