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 has implemented and maintains a quality management system modeled after the Guidance Document Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients published by the FDA and ICH in September 2016. The document control system in place is in alignment with FDA guidance for Phase 1 clinical trial material as described in 21 CFR Parts 210 and 211 and is compliant with GMP manufacturing standards. Acceptance criteria for users of VitaCyte products are encouraged to consider the tiered risk assessment model described in USP General Chapter <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products.

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. No animal sources materials are used in the manufacture of BP Protease or AF Thermolysin.

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.