PeproGMP^® Cytokines:

Helping Unlock the Promise of Cellular Therapies and Regenerative Medicines

In response to our clients’ needs, and the requirements of the cell and gene therapy markets, we are pleased to introduce our new state-of-the-art manufacturing facility in Cranbury, NJ.

The rapidly evolving field of regenerative medicine offers exciting opportunities to develop new solutions for an array of diseases, injuries, and genetic disorders. With the recent expansion of our new facility, PeproTech is able to meet the demand of the advancing markets in cell, gene, and tissue therapies. Our 65,000 square foot facility has significantly more square footage for GMP cleanrooms and supports the manufacturing of our bacterial expressed GMP products and expansion into cell culture derived GMP products.

Consistent with U.S. federal requirements and best practices for cell therapy, gene  therapy, and tissue-engineered products for clinical applications, PeproGMP® Cytokines are  manufactured and tested in compliance with relevant US FDA GMP (Good Manufacturing Practices) regulations and the ISO 9001 quality management systems standard, without the use of animal-derived materials.

PeproTech's GMP Products

We are continually adding new GMP products. Please contact [email protected] for our most up-to-date product list.

Quality Management

PeproTech ensures that all aspects of our quality management system—from management of raw materials and equipment to facilities maintenance (environmental monitoring), manufacturing processes, audits, and inspection processes—are in compliance with relevant US FDA GMPs and all applicable regulatory and standards requirements.

The benefits of our rigorous process are clear: PeproGMP® Cytokines offer safety, purity, and simplified use in ex vivo manufacturing processes, as described in USP (United States Pharmacopeia) Chapter <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products. 

All PeproGMP® Products are manufactured using animal-derived component-free materials Controlled-certified ISO7 and ISO8 Cleanrooms Qualification & Validation Program Materials Management (Including supplier qualification, controlled & qualified raw materials) 100% Traceability Personnel Training Program Environmental Monitoring Equipment Calibration & Maintenance Rigorous Quality Control Program Documentation Control & Records Stability Program Controlled Processes QA Review & Support Master Quality & Supply Agreement Aseptic Techniques & Sterile Filtration Management Review Compliant and Recall Procedures

Quality Control

We perform extensive quality control testing to verify that PeproGMP^® Cytokines meet rigorous standards for purity, identity, safety, activity, and lot-to-lot consistency.

Identity and Purity

• N-terminal amino acid sequence analysis
• Molecular weight determination by mass spectrometry
• Reversed-phase HPLC analysis
• SDS-PAGE
• Western blotting

Protein Content

• UV spectroscopy
• SDS-PAGE

Safety Testing

• Residual E. coli DNA testing
• Sterility Testing (USP Standards): beginning, middle and end processes
• Low Endotoxin
• Mycoplasma

Biological Activity

• Specific activity determined by product-specific in vitro bioassay, against reference standard and (when applicable) against WHO standards

Documentation

• Certificate of Analysis (COA)
• Certificate of Origin (COO)
• Safety Data Sheet (SDS)

Q&A