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.
Available PeproGMP recombinant proteins
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.
PeproTech GMP protein manufacturing capabilities
Thermo Fisher Scientific continues to invest to serve your needs with quality materials for developing cell therapy and vaccines.
- Ongoing investment in manufacturing facilities to ensure supply
- Continuous education to maintain regulatory expertise
- Technical experts to support your processes and goals
Facilities for recombinant protein GMP manufacturing
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
Closed systems for therapeutic-quality cell processing from Thermo Fisher Scientific
PeproGMP quality standards and regulatory compliance
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.
Testing of GMP proteins
Extensive quality control tests are performed to verify that PeproGMP cytokines meet rigorous standards for purity, identity, safety, activity and consistency.
Identity and purity | N-terminal amino acid sequence analysis |
Protein content | UV spectroscopy |
Safety | Residual E. coli DNA testing |
Biological activity | Specific activity determined by product-specific in vitro bioassay, against reference standard and (when applicable) against WHO standards |
Documentation | Certificate of Analysis |
Certification
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
Consistent quality and performance of GMP cytokines
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.
Lot-to-lot consistency
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.
Figure 1. Cell proliferation assay comparing two lots of PeproGMP FGF-Basic demonstrating consistent potency in stimulating growth of 3T3 cells. Representative data.
Figure 2. Cell proliferation assay comparing two lots of PeproGMP IL-2 demonstrating consistent potency in stimulating growth of CTLL-2 cells. Representative data.
Grade-to-grade consistency
Western blot and cell proliferation assays demonstrate grade-to-grade consistency, authenticity and purity from all ranges of PeproTech recombinant proteins.
Figure 3. Western blot comparing molecular weight of the same FGF-Basic protein across all three grades of PeproTech recombinant proteins. There is no observable difference in molecular weight among the RUO, animal-free and GMP grades of protein, indicating that the proteins are structurally very similar.
Figure 4. Cell proliferation assay demonstrating the bioactivity of PeproTech FGF-Basic protein from three different grades (RUO, animal-free and GMP) that were manufactured in separate labs and lots. The three recombinant protein grades and batches exhibit highly similar potency in stimulating cell growth.
Gibco PeproTech quality management system
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
PeproTech GMP recombinant proteins are manufactured for use as ancillary materials by applying applicable principles of GMP and quality control requirements from USP (United States Pharmacopeia) Chapter <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products.
Dedicated recombinant protein quality assurance teams
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
GMP recombinant protein resources
Resources
Recombinant proteins learning center
Learn what recombinant proteins are, what they are used for, and what types are available
About PeproTech proteins
Learn about the PeproTech brand of recombinant proteins
Gibco cell culture basics
Learn about all aspects of cell culture
3D cell culture protocols
See which recombinant proteins are used to generate organoids
Western transfer protocols and recipes
Procedures and buffers for performing western blots
Cytokine and growth factor signaling pathways
Explore the role of proteins and cytokines in various signaling pathways
Support
Recombinant Proteins Support Center
Find Getting Started guides, protocols, troubleshooting, and other resources
Recombinant proteins FAQs
Search the database to find answers to your questions
Contact general support
Get technical or customer support for any recombinant protein; find SDS, CoA, and phone numbers based on a specific product
Contact GMP support
Get in touch with GMP technical and regulatory experts
Related Products
Intended use of the products mentioned on this page vary. For specific intended use statements please refer to the product label.
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