Cell therapy grade laminin for allogeneic stem cell therapy

Purpose and goal:

Inherited retinal diseases constitute a serious medical burden and there are today no curative treatments. While gene therapeutic intervention can only target a single specific genotype, regenerative therapy using stem cell derived retinal cells could provide a curative treatment option that is independent of the patient’s genotype. Project CTG-LAST aims to develop and produce a stable source of cell therapy grade laminin-523 as critical ancillary material in retinal cell therapy development.

Expected results and effects:

Alder Therapeutics will have secured supply of a key ancillary reagent required for the development of its retinal progenitor cell-therapy development program. BioLamina will be able to commercialize one additional laminin product for research purposes and potentially other indications. FyoniBio will have established a new manufacturing process for a complex human recombinant protein which can be referenced and sold as a service to other third-party clients in the future.

Approach and implementation:

Successful completion of the proposed collaboration project requires combining the expertise and know-how of Alder Therapeutics (Sweden), BioLamina (Sweden) and FyoniBio (Germany). Alder has access to proprietary retinal stem cell differentiation protocols for testing the efficacy of the recombinant LN-523 product. BioLamina owns proprietary know-how for the development, manufacturing, and quality testing of laminin cell culture substrates while FyoniBio has the necessary cell lines and masters the process and analytical development of complex protein manufacturing.