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Quality assurance

Building trust through quality and safety

Special instrument set for extraction and transplantation
Working in conjunction with B. Braun/Aesculap, we have developed special instruments for extracting biopsies and for the transplantation of autologous chondrocytes.  These make the OP procedure both easier and more standardized. The instruments can be provided on a loan basis without additional cost, and serviced and maintained by B. Braun/Aesculap®.
Manufacture
From the beginning of the process to the point where they are ready to ship, manufacture of all NOVOCART® products takes place in state-of-the-art, GMP-compliant cleanroom facilities equipped with isolators that meet the requirements of cleanroom class A. All steps in the process are standardized, and are continually checked and documented. By using only tested homologous serum and barring animal-derived ingredients from the culture procedure, we are in a position to practically exclude the possibility of immunological reactions or the transfer of infections of animal origin. We use neither antibiotics nor antimycotics. In addition, we conduct repeated sterility checks.
Production period
The manufacture of NOVOCART® 3D and  NOVOCART® Inject takes exactly three weeks from the point at which the biopsy is extracted. With NOVOCART® Disc, the cultivated disc cells are transplanted three months after operative removal of the disc prolapse. The relatively long period between extraction and transplantation must be adhered to in order to ensure that the fibrous ring (annulus fibrosus) surrounding the ring is fully healed.

Quality checks and records
The high quality of the cells and molecular biology of the transplant are checked using state-of-the-art analysis techniques (e.g. quantitative PCR) immediately prior to the return of the product to the user. Detailed log sheets with concluding test reports on the sterility tests, cellular and microbiological analyses are prepared for each transplant. Along with the product, the user receives a concluding test report which, in addition to information as to the sterility tests conducted, contains detailed information about cell vitality and the quantitative expression analyses performed.
The binding “Resolution on quality assurance measures to be applied for autologous chondrocytes in the knee joint”, issued by Germany’s Joint Federal Committee (GBA) in line with section 137c of the country’s Social Act (SGB) is fully taken into account in respect of our products. ACT with NOVOCART3D is this a reimbursable procedure under Germany’s statutory health insurance scheme (GKV).

Our research team has been recognized with the Scientific Award of the Association for Orthopaedic Research (AFOR) for the cellular and microbiological principles of the culture procedure developed by TETEC for retaining the differentiated phenotype of chondrocytes.