High Quality Product
The manufacturing process is designed to consistently produce a high quality product. Genzyme utilizes multiple unique and proprietary methods and assays throughout the manufacturing process. Lot segregation and closed culture conditions are in place to prevent cross-contamination between individual patient cell lots.
Assessments help ensure that each individual patient lot is tested for safety and quality and that the manufacturing process remains aseptic.
CARTICEL Assurance Assays
Each patient's cells are characterized to ensure that they meet Genzyme's quality manufacturing standards for future implantation:
- Viabliity assay:
- Each individual CARTICEL lot is tested to ensure that there are enough live chondrocytes for implantation.
- Identity assay:
- Our proprietary identity assay distinguishes chondrocyte cells from non-chondrocyte cells.
- Biopsy processing stage:
- Visual inspection for sterility.
- Cell culturing stage:
- Monitor cell growth, morphology, continued sterility inspection.
- Final CARTICEL product release specification stage:
- In order for CARTICEL to be released for implantation, it must undergo rigorous assessments including viability, sterility, endotoxin and morphology testing and the novel identity release assay.
- Potency assay: IN DEVELOPMENT
- Genzyme further innovates by continuing to develop an additional assay to determine the chondrogenic potential of the cells.
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Have Questions?
Check out our FAQs for answers—or contact a Carticel Care® Coordinator at 800-453-6948, Option #2, for more detailed information.
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