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.
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.
PeproTech products have been manufactured to be GMP-compliant products, wherein GMP compliance is consistent with provisions of the United States Food and Drug Administration (FDA). Products sold by PeproTech, however, do not have approval or clearance by any worldwide regulatory authority, including the FDA. PeproTech products which are, or may be, used to manufacture human or veterinary drug products, food additives, diagnostic reagents, medical devices, dietary supplements, or cosmetics as defined or described by the United States Federal Food, Drug and Cosmetic Act (FDDCA) are not intended for direct human use. The products are intended for in vitro or ex vivo use only. Unless otherwise indicated, all products are distributed and sold for use in the manufacture or production of a therapeutic product or for chemical purposes only. Thus, PeproTech products are not intended for direct human exposure by any route, including but not limited to intravenous injection, oral ingestion, topical application, or inhalation. All products sold by PeproTech are to be used by qualified professionals only.
Purchasers of PeproTech products agree to comply with all provisions of applicable federal, state and local statutes, rules, regulations, ordinances, and orders in any use they may make of PeproTech products. Products sold by PeproTech do not have clearance or approval of any regulatory authority, including the FDA. Because PeproTech products are intended for research use or use in the manufacture of products intended for use in humans, the products may require listing on the United States Environmental Protection Agency (EPA) Toxic Substances Control Act (TSCA) Inventory. Purchasers assume the responsibility to ensure that any PeproTech product purchased are approved under TSCA, if applicable, and to ensure that the products are in compliance with any relevant TSCA provisions. Purchasers assume similar responsibilities to ensure that any products they purchase are in compliance with other relevant regulatory authority provisions.