QED Technology: Quality Ensured by Design.
With Carticel, our QED Technology is behind every step of the process. It’s all designed to consistently produce the highest-quality product possible. To ensure this quality, Vericel utilizes multiple unique and proprietary methods and assays throughout the manufacturing process.
Carticel Quality Assurance
- Lot segregation and closed culture conditions are in place to prevent cross-contamination between individual patient cell lots.
- Biopsy processing and cell culturing stages:
Continuous monitoring of cell growth, morphology, and sterility.
- Final Carticel product release specification stage:
In order for Carticel to be released for implantation, it must undergo rigorous assessments including viability, identity, sterility, endotoxin, and morphology testing.
- Viability assay:
Each individual Carticel lot is tested to ensure that nearly all of the millions of chondrocytes are indeed live and therefore will be biologically active once implanted.
- Identity assay:
Our proprietary identity assay distinguishes chondrocyte cells from non-chondrocyte cells. This ensures that we are providing as close to only chondrocytes as possible.
- Potency assay: IN DEVELOPMENT
Vericel further innovates by continuing to develop an additional assay to determine the chondrogenic potential of the cells.