PeproGMP Recombinant Proteins

Recombinant proteins are often among the key raw materials used in clinical manufacturing of biotherapeutics, so strong supply chain continuity and scaling capabilities are important considerations when choosing a GMP cytokine or other GMP protein supplier.

Thermo Fisher Scientific offers GMP proteins that can help you seamlessly scale your cell production process while meeting all clinical requirements. Gibco PeproGMP cytokines are designed and manufactured to support end-to-end manufacturing of cell therapies and other biotherapeutics.

All PeproTech GMP proteins are manufactured in E. coli using defined media, enzymes, and chemicals that are animal- and human-origin free. GMP recombinant proteins are available for a wide range of applications, including culture and modification of stem cells, immune cells, and organoids.

PeproGMP cytokines are developed and manufactured with quality, scale, and regulatory compliance in mind.

Click on any protein name below to learn more about the PeproGMP cytokine or contact a PeproTech specialist to discuss your needs for GMP proteins.

Thermo Fisher Scientific has a dedicated 65,000 square foot facility for recombinant protein development and manufacture. All PeproTech recombinant proteins are now manufactured at this facility for high quality and consistency.

PeproTech proteins manufacturing facility features:

• Controlled and certified ISO Class 7 and Class 8 cleanrooms for GMP manufacturing
• Dedicated animal-free labs
• Centralized manufacturing to ensure lot-to-lot consistency

Your quality system relies on the quality management systems of your raw material suppliers. PeproTech GMP proteins are backed by robust testing, documentation, and regulatory support to help reduce your risk, quality system burden, and regulatory submission complication.

Extensive quality control tests are performed to verify that PeproGMP cytokines meet rigorous standards for purity, identity, safety, activity and consistency.

Documentation and traceability are critically important for robust quality assurance. Each purchase of PeproGMP cytokines includes access to certificate of analysis, safety data sheets, and certificates of origin for GMP products.

CoA information included:

• Reconstitution instructions
• Specifications:
  • Endotoxin level
  • Protein content
  • N-terminal AA sequence validation
  • Sterility
  • Purity
  • Biological activity
  • Protein identity validation
  • Mycoplasma testing validation
  • Residual E. coli content testing

Consistency in potency is important to your ability to scale your discoveries easily without need for extra validation due to significant differences in source material and to assure that your manufacturing processes will also remain consistent from lot to lot. PeproGMP cytokines are manufactured within the same facility using the same manufacturing expertise as PeproTech RUO and animal-free proteins, just under the more stringent manufacturing guidelines for GMP-grade products and in dedicated GMP-compliant laboratories.

PeproGMP cytokines are tested for biological activity and potency in a cell proliferation assay. These lot-to-lot comparisons demonstrate consistent potency of PeproGMP cytokines across manufacturing lots. 

Western blot and cell proliferation assays demonstrate grade-to-grade consistency, authenticity and purity from all ranges of PeproTech recombinant proteins.

When developing lifesaving and world-changing therapeutics and vaccines, choose a supplier with rigorous quality standards. The Gibco PeproTech QMS includes important elements such as:

• Supplier qualification standards
• Traceability and monitoring of raw materials
• Rigorous QA training program for employees
• Environmental monitoring
• Equipment calibration and maintenance program
• Documentation and records control
• Product stability studies
• Master quality and supply agreements

Upon purchase of a PeproGMP cytokine, you’ll receive access to a dedicated support team to help you as you progress from research to clinical trials and into product manufacturing. Our expertise in regulatory compliance, quality assurance practices and technical support truly provides a “white glove” level of service.

Have regulatory or quality questions about PeproGMP cytokines?
Contact recombinant proteins regulatory support