GLP -pre-clinical development according to the principles of "Good Laboratory Practice"
Bone marrow-derived stem cell products for cardiovascular application fall under the regulatory frame of ATMPs. Thus the same regulatory requirements of medicinal products are in principle effective for pre-clinical evaluations. However, the authorities acknowledge that these standard requirements are not automatically applicable because of the unique and very diverse structural and biological properties of ATMP.
Accordingly, there are so far no uniquely defined requirements regarding the quality standards according to GLP. In addition, appropriate models and corresponding certified laboratories do not exist sufficiently. In close connection with the responsible authorities the RTC currently develops, selects, and evaluates parameters and procedures for proving the quality and safety of stem cell products and -if possible- the RTC will establish standardized tests according to the requirements of the “Good Laboratory Practice”
For this purpose, corresponding laboratories and instruments are being qualified, if necessary calibrated and the required evaluation plans are being compiled. The involved staff receives special training for all organisational and experimental processes. In the near future, we plan to conduct all documentation in digital form. Our GLP-test procedures are being applied to our own investigations And will be in the future offered as service to external parties.
The GLP consensus documents of the OECD (Organisation for Economic Co-operation and Development) give direction to the establishment and implementation of the principles of GLP. In Germany, the OECD consensus documents-based EU-directives have been implemented into the German Chemicals Act (ChemG, 6. Article , § 19a-d as well as addendum 1 of § 19a Article 1)) in 1990.
Annex 1 ChemG