Feasibility phase

Cell culture media play an important role in the production of cellular drugs and in basic research. How ever, the traditional use of fetal calf serum as a growth supplement harbours numerous problems: These include its unknown exact composition, its ethically questionable extraction (blood taken from the hearts of unborn calves) and the risk of infection. Human platelet lysate (HPL), obtained from blood platelets from blood donors, offers a promising alternative.

Freeze-Dried HPL for Ethical and Efficient Cell Cultures

Until now, however, it has had to be stored and transported in liquid or frozen form, which is energy-intensiveand technically inconvenient. The LyoThroReg team has developed a method to overcome these limitations. The project team uses expired platelet concentrates from blood donors and combines multiple batches to ensure less variation in the final product. Subsequent freeze-drying reduces the weight and storage temperature of HPL while maintaining the quality and efficacy for the cell culture. Due to the growth factors it contains, freeze-dried HPL can also be used directly as a clinical drug for cartilage regeneration in musculoskeletal diseases. LyoThroReg aims to bring freeze-dried HPL to market maturity as a sustainable and ethically safe serum supplement in biomedical research and cell therapy.

Conceptual phase

Calf serum (FCS) is used in the cultivation of cells in basic biomedical research and the production of modern therapeutics. FCS is obtained through the slaughter of unborn calves and is increasingly criticised and regarded as unethical. Human platelet lysate (HPL) is a promising, sustainable and ethically sound alternative to FCS. It is made from platelet (thrombocyte) concentrates (frozen) from donor blood, which have become unusable for patient care due to their short shelf life of four days. They must then be discarded. However, components that promote cell proliferation remain active for longer and can be extracted. The reuse of frozen food as HPL therefore makes sense ethically and economically in many respects.

In the LyoThroReg project, the previously optimised production method of HPL is being further developed into so-called lyophilised HPL (L-HPL) under the aspect of pharmaceutical standards and prepared for production scale. The potential applications for L-HPL and strategies for recycling and marketing will additionally be analysed in detail during the exploratory phase.

The aim is to bring sustainable and ethically harmless serum sales to market maturity and application in basic biomedical research, in the production of cell therapeutics and possibly as a novel regenerative therapeutic agent.

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