Regulatory Position & Legal Statement
VitaCyte’s Regulatory Position
Intended Use and Limitations: VitaCyte LLC manufactures CIzyme™ purified tissue dissociation enzyme products for a variety of applications. Currently, manufacturing reagents are not generally prepared in compliance with current Good Manufacturing Practices and are therefore, for research use only. However, VitaCyte has established a quality system for the manufacture, testing and storage of tissue dissociating enzymes. CIzyme™ products are manufactured in accordance with the principles for clinical trial material outlined in the International Conference on Harmonisation (ICH) document ICH Q7a “Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients”. The document control system in place is in alignment with FDA guidance for Phase I material as described in 21 CFR Parts 210 and 211. In addition, document controls are in place to minimize the chances of cross-contamination. Guidance for use of reagents in clinical cell transplantation procedures is governed by local Institutional Review Boards and regional Health Authorities.
Animal Derived Components: The CIzyme™ Collagenase and Clostripain 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. Partially 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.
VitaCtye Privacy Statement
In general, you can visit VitaCyte on the Internet without telling us who you are and without giving any personal information about yourself. There are times, however, when we may need information from you. How we treat that information is described in this Privacy Statement.
You may choose to give us personal information in a variety of situations. For example, you may want to give us information, such as your name and address or e-mail address, to correspond with you or to process an order. You may give us your credit card details to make a purchase. We intend to let you know how we will use such information before we collect it from you; if you tell us that you do not want us to use this information to make further contact with you beyond fulfilling your requests, we will respect your wishes. If you give us personal information about somebody else, such as a work colleague or a spouse, we will assume that you have that person’s permission to do so.
Please be aware that in certain circumstances, it is possible that personal information may be subject to disclosure pursuant to judicial or other government subpoenas, warrants, or orders.