Good Manufacturing Practices (GMP)-grade Proteins

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. Please see the CofA for product-specific testing and guidelines.

• 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
  • Ph. Eur. General Chapter 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products

GMP Protein FAQs

What is a GMP Protein?

The proteins are manufactured under guidelines that allow for their use as ancillary materials in cell therapy or for further manufacturing processes. GMP proteins also come with extensive documentation and traceability, as well as additional quality control testing. They may or may not be manufactured using animal-free processes depending on the characteristics of the protein.

What is the Difference Between R&D Systems Traditional Proteins and GMP Versions?

Often the sequence, the expression system, and the basic manufacturing SOP for traditional and GMP proteins are the same. This makes the transition from using research-use proteins to GMP as seamless as possible. In addition, compared to traditional proteins, GMP proteins come with extensive documentation for traceability as well as additional quality control testing and quality assurance review.

What Should I Expect from a GMP Protein Manufacturer?

Some basic things to expect include a lot-specific Certificate of Analysis that will detail the identity of the protein and analytical testing that has been done to ensure the material is meeting specifications. A Certificate of Origin may be obtained that provides traceability of the materials used in manufacturing of the protein. This would be key document for those wanting to establish they are working with animal-free raw materials. Drug Master Files (DMFs) may also be submitted to regulatory authorities by the supplier. DMFs provide details about manufacturing process and can be referenced during filing. They also provide a mechanism for submitting proprietary information. A supplier should be very open to audits of their facilities where you can review batch records that provide critical information about lot-to-lot consistency. Lastly, look for a protein manufacturer with a mature quality management system (QMS), including GMP and quality experience, who can be an asset as you move through the manufacturing process.

When Should I Transition to GMP?

Moving to GMP proteins as early as possible, potentially even during research and development work, is the best course. This is especially the case if you are using cytokines or growth factors from a supplier that doesn’t also offer GMP cytokines and growth factors for further manufacturing.

Where are Your GMP Proteins Made?

We manufacture all R&D Systems GMP proteins at our headquarters in Minnesota. We’re committed to providing the best GMP proteins on the market, and we’ve just opened a brand new state-of-the-art manufacturing facility to meet the increasing demands of therapeutic cell manufacturing. Learn about our new GMP manufacturing facility.

Are R&D Systems GMP Proteins Animal-free?

If possible, R&D Systems GMP proteins are made in an entirely animal-free process using E. coli as the source. However, there are some proteins that require production in eukaryotic systems to maintain activity. This may be due to protein folding or post-translational modifications that can only be accomplished by making the protein in a eukaryotic cell line. In all cases, it is clearly stated on the website whether a specific protein is produced in an animal-free process. See our safety page for a detailed definition of our animal-free process. View our Animal-free Proteins.

Are GMP proteins from R&D Systems Pharmaceutical or Therapeutic-grade?

No, our GMP proteins can only be used as raw materials or ancillary reagents for cell culture or other processes involved in ex vivo manufacturing.

Do You Have Drug Master Files?

Drug Master Files (DMFs) are kept on record in the United States at the FDA. These records detail all aspects of the manufacturing, including proprietary processes. They can be accessed to support new submissions. R&D Systems is in the process of submitting DMFs for all GMP cytokines and growth factors. Please contact us for detailed information on your protein of interest.

Do You Run Cell-based Assays to Test GMP Protein Performance?

Each GMP cytokine and growth factor is tested for performance using cell-based bioassays that include proliferation, induced cytokine secretion, cytotoxicity, and others. Details regarding activity testing for a given cytokine are regularly shared during audits of our facilities.

Related Links:

• New! GMP ExCellerate™ iPSC Expansion Medium
• GMP Cytokines and Growth Factors for Therapeutic Manufacturing Brochure
• Key Considerations for Cytokine Supplier Selection for Cell Therapies Article
• Streamlining Transition to GMP at Bio-Techne
• Fluorescent-Labeled Recombinant Proteins
• Cell and Gene Therapy Manufacturing
• GMP Small Molecules
• GMP Capabilities at Bio-Techne
• GMP Quality Policy and Regulatory Support
• Immune Cell Therapy Workflow Wall Poster
• GMP Antibody Services
• Webinar The CAR ToolKit: Progress and Challenges in CAR-T/NK Cell R&D and Manufacture