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.
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.
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|
|FGF basic (145 aa)||E.coli||3718-GMP||AFL3718|
|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|
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
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
(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).
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.