Helping unlock the promise of cellular therapies and regenerative medicines
The rapidly evolving field of regenerative medicine offers exciting opportunities to develop new solutions for an unlimited array of diseases, injuries, and genetic disorders. Modern advances in immunology, developmental biology, genetics, and cell biology are driving research in this emerging area–and opening up a huge new potential market for related therapies.
As cell therapies transition from the lab to patients’ bedsides, ensuring the highest levels of quality and safety is a significant and critical challenge. PeproTech’s PeproGMP® Cytokines help researchers meet that challenge. Consistent with 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 US FDA GMP (Good Manufacturing Practices) regulations and the ISO 9001 quality management systems standard, without the use of animal-derived materials.
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.
- ISO7-certified cleanrooms and controlled laboratories
- Qualification and validation program
- Materials management
- Personnel training program
- Environmental monitoring
- Equipment calibration and maintenance
- Rigorous quality control program
- Documentation control and records
- Stability Program
- Controlled Processes
- QA review and Support
To learn more about PeproGMP® cytokines visit our website at www.peprotech.com/gmp.