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GMP Proteins for Therapeutic Manufacturing

Immune cell therapies, stem cell therapies, and regenerative medicine, often grouped into the category of advanced therapy medicinal products (ATMPs), offer some of the most revolutionary and exciting new approaches for treating human disease. Because they utilize living cells or tissues as the therapeutic, the manufacturing process is vastly more complex than those of more traditional treatment methods. The use of high-quality media supplements such as growth factors and cytokines is paramount to ensuring safety, efficacy, and minimizing batch-to-batch variability.

R&D Systems 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. We often use the same clone, sequence, and expression system as our research grade materials. This makes the switch to GMP as seamless as possible.

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

Announcing Our New State-of-the-Art GMP Protein Manufacturing Facility

We're committed to meeting the increasing demands of therapeutic cell manufacturing. Our facility supports large-scale production of GMP-grade materials including E. coli-derived recombinant proteins.

Combining Purity, Bioactivity, and Consistency

As growth factors and cytokines are produced in biological systems, they are inherently susceptible to variability. To maximize efficacy and safety, a supplier should have a quality management system in place to ensure lot-to-lot consistency and highly-purified formulations. A highly potent cytokine or growth factor can also lower the amount needed for use and in turn lower costs.

GMP Proteins

Protein (Human) Source Catalog # DMF Filed For GMP
Activin A CHO 338-GMP Yes
BMP-2 CHO 355-GMP  
GDF-8/Myostatin NS0 788-GMP  
GDNF NS0 212-GMP  
HGF NS0 294-GMP  
KGF/FGF-7 E.coli 251-GMP  
Noggin NS0 6057-GMP  
Noggin Fc Tag NS0 3344-GMP  
TGF-β1 CHO 240-GMP  
Wnt-3a CHO 5036-GMP  

What is an Animal-Free Protein?

Production and purification procedures for these GMP proteins use equipment and media that are certified animal-free. Our dedicated controlled-access animal-free laboratories ensure that at no point in production are these products exposed to potential contamination by animal components or byproducts.

Animal-Free GMP and Animal-Free Preclinical Proteins

Protein (Human) Source Catalog # GMP Animal-Free DMF Filed For GMP Catalog # Preclinical Animal-Free
BMP-4 E.coli 314E-GMP   AFL314E
EGF E.coli 236-GMP Yes  
FGF basic (145 aa) E.coli 3718-GMP   AFL3718
Flt-3 Ligand/FLT3L E.coli 308E-GMP Yes AFL308E
GM-CSF E.coli 215-GMP   AFL215
IFN-γ E.coli 285-GMP Yes AFL285
IGF-I E.coli 291-GMP   AFL291
IL-1β E.coli 201-GMP   AFL201
IL-2  E.coli 202-GMP Yes AFL202
IL-3 E.coli 203-GMP   AFL203
IL-4 E.coli 204-GMP Yes AFL204
IL-6 E.coli 206-GMP   AFL206
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 
IL-21 E.coli 8879-GMP Yes AFL8879
LR3 IGF-I E.coli 8335D-GMP    
M-CSF E.coli 216-GMP   AFL216
PDGF-AA E.coli 221-GMP   AFL221
PDGF-BB E.coli 220-GMP   AFL220
SCF/c-kit Ligand E.coli 255B-GMP Yes AFL255
Sonic Hedgehog (C24II) N-Terminus E.coli 1845-GMP   AFL1845
Sonic Hedgehog N-Terminus E.coli 1314-GMP    
Thrombopoietin E.coli 288E-GMP   AFL288 coming soon
TNF-α E.coli 210-GMP   AFL210
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.

Serum-Free and Animal-Free Cell Culture

 

Increase the consistency of your cell cultures as you approach translational studies for regenerative medicine and cell therapy programs. Adopting these media will

  • Reduce variability in media composition
  • Simplify compliance with regulatory guidelines
  • Simplify comparability testing for raw material changes
Adherent cells in culture supported by extracellular matrix

Certificate of Analysis Specifications

Each lot of GMP protein manufactured comes with a Certificate of Analysis (CofA) that documents the quality systems and product specifications. Prior to protein CofA release, a full QA review of all batch and bottling records is performed. Here is what you can expect to find on our CofAs:

  • Source information
  • N-terminal sequencing of the first 10 amino acids
  • Purity Specification
  • Bioactivity assay including testing against a master lot
  • Sterility testing to USP
  • Endotoxin levels
  • Host cell protein specification
  • Host cell DNA specification
  • Stability statement
  • Certifications and Regulatory Guidelines followed, including:
    • ISO 9001:2015, ISO 13485:2016-certified 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

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). 

T Cell-Based Therapies eBook

T Cell-Based Therapies eBook

This new eBook provides an overview of several biological and manufacturing challenges facing the development and production of T cell therapies. It follows with examples of how Bio-Techne products and services can address these challenges at each stage of the process.

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