BioSeed®-C as an Autologous Chondrocyte Implant has been regulated as an ATMP (Advanced-Therapy Medicinal Products) in Europe with the requirement of a central marketing approval by the EMA (European Medicines Agency).
The German Authorities have implemented a transitional phase for local, German approval in order to help Germany based companies to prepare and to achieve EMA approval later.
BioTissue has the allowance for BioSeed®-C being marketed in Germany by the competent Federal Authority (Paul Ehrlich Institute). With this allowance BioSeed®-C can be marketed in Germany only.
BioTissue´s GMP Laboratory has a “class D” cleanroom environment and all preparatory steps of the actual manufacturing are taken place under “class A” cleanroom conditions in so-called “isolators”. Clean room environments are ensured by qualified pressure cascade and laminar flow and the most important parameters, as pressure, temperature, laminar flow, number of particles and microbes are continuously controlled and documented as required by the EU GMP Guidelines.
In the first step, single cells will be separated out of the cartilage biopsy by enzymatic digestion. Approximately 100.000 cells can be attained out of an average biopsy. In order to achieve suitable cell numbers for the treatment of cartilage defects with a suitable size of BioSeed®-C implants, cells must undergo an intensive phase of proliferation. This stage takes place in culture flask for approximately two weeks. During this two weeks nutrition media of the cells has to be exchanged in every second day and in case of confluent colonisation of the culture flasks, cells have to be split into more culture flasks. After achieving suitable cell numbers of many ten millions of cells, cells will be disseminated into the two component scaffold, described above, in order to trigger their re-differentiation to joint hyaline cartilage in the three-dimensional culture environment.
After approximately five further days of culture, BioSeed®-C implants are packaged into sterile bags, containing a suitable transport media ensuring sufficient nutrition for the cells during transportation to the hospital. The completed BioSeed®-C implants will be released by the responsible person (Qualified Person regarding to Pharmaceutical Law), after approving the fulfilment of all specifications regarding sterility, cell account, nutrition activity, etc.
During the entire culture period of 4 to 5 weeks, different clean room environments, equipment, culture media, reagents, disposables, etc., are controlled microbiologically.