Are your enzymes approved for clinical use?

To be determined.

VitaCyte’s products are labeled for research use only or as GMP Grade. All products are manufactured in accordance with the principles for clinical trial material outlined in the International Conference on Harmonization (ICH) document ICH Q7A,  “Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients”. The GMP Grade products are bottled and lyophilized under more tightly controlled conditions. Our internal document control system 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. Presently, the FDA or EMA have not defined any requirements for use of enzymes as ancillary products in therapeutic cell isolation.