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.
Our GMP ProDots™ Proteins address the time and handling challenges facing the cell therapy industry. They are formulated as pre-aliquoted, dissolvable spheres and are packaged in single-use bags for easy welding into closed-systems for media prep.
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|
*GMP ProDots Proteins closed system formulation available.
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
R&D Systems™ GMP Proteins are intended for use as ancillary materials in GMP manufacturing of investigational or marketed clinical products, such as cell therapy, gene therapy, tissue-engineered products, combination products, or other Advanced Therapy Medicinal Products. They are not therapeutic products or excipients and are not suitable for direct administration to humans.