VitaCyte’s Regulatory Position
Overview: VitaCyte LLC manufactures CIzyme™ purified tissue dissociation enzyme products for research use only. VitaCyte is aware that advances in cell transplantation procedures may lead to the use of these products to prepare cells for routine clinical or clinical research procedures. The guidance for use of research reagents in clinical or experimental procedures is governed by existing laws and regulations. Responsibility for applying this product in any clinical procedure lies solely with the end user and Institution.
Intended Use & Limitations: CIzyme™ purified tissue dissociation enzymes are not intended for use in diagnostic or therapeutic procedures. These products are not manufactured under U.S. Good Manufacturing Practices nor are individual lots tested for sterility or pyrogenicity. The CIzyme™ Collagenase products are purified from culture supernatants from C. histolyticum cultures that contain porcine gelatin and porcine pancreatic enzyme derived from U.S. and Canadian sources. No bovine derived animal products are used in any step used to prepare the purified collagenase enzymes. CIzyme™ Thermolysin is purified from culture media containing bovine casein from milk used for human consumption. Purified thermolysin is further purified by column chromatography to reduce any residual contaminants and to improve the consistency of the final product. CIzyme™ BP Protease uses no animal proteins at any step of the fermentation or purification process.
Requirement prior to shipping product: VitaCyte requires that all customers complete an acknowledgment form to confirm that the end user confirms they understand the intended use and limitations of VitaCyte’s products. The product will ship product once VitaCyte receives the completed form. Download a copy of the Acknowledgement Form