Regulatory and Source Materials

Regulatory Environment

Cell isolation reagents are defined by the regulatory agency as ancillary reagents. Until specific regulations for ancillary reagents are articulated, VitaCyte products are being used in clinical trials in both the US and Europe. Local institutional review boards have also approved the use of VitaCyte purified enzymes for the isolation of different cell types including the Clinical Islet Transplantation trial (IND# BB-IND 9336). 

VitaCyte remains keenly interested in the positions and attitudes the FDA takes on cell therapy. We are actively developing a quality system that will enable products to be manufactured in compliance with future GMP regulations.

Animal Source Materials

VitaCyte recognizes the concern of using animal sourced materials in therapeutic applications. No bovine material is used at any point of the manufacturing process for our collagenases,* thus avoiding the risk of BSE. The only animal sourced material used in the preparation of collagenase is porcine gelatin used in the fermentation of C. histolyticum. Gelatin is necessary to achieve the level of collagenase expression necessary for the preparation of VitaCyte enzymes. The risk of TSE from porcine sources is quite minimal.

VitaCyte is developing recombinant collagenases using engineered prokaryotic cell lines to circumvent the concerns of porcine sourced materials and provide a completely animal-free version. Bovine casein for human consumption is the only animal product used in the preparation of Thermolysin. No animal sources materials are used in the manufacture of BP Protease.

With purchase, we provide a statement of animal origin certificate for each product that discusses the risk of adventitious agents. You can also download certificates of origin from the Product Documentation page, found under Resources in the main menu.

See also our Regulatory Statement.