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GMP Cytokine and Growth Factor Manufacturing for Cell Therapy

GMP Protein Production Facility

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.

 

 

 

Bio-Techne's GMP Manufacturing Facilities - Invested In the Next Generation of Therapeutics

Customer Success Stories

Key Features of Our New Facility

GMP Capabilities
  • 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
ScaleReady Logo

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.

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.

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Analysis of the Activity, Lot-to-Lot Consistency, and Purity of GMP-grade Recombinant Human IL-7

Activity, lot-to-lot consistency and purity testing of R&D Systems 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

Activity, lot-to-lot consistency and purity testing of R&D Systems 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