Bio Elpida is the CMO specialised in the development of cell therapy products and innovative therapy products
The expertise of the company encompasses all the steps from R&D
and pharmaceutical development to GMP manufacturing
of cell therapy products based on innovative approaches for:
The goal of Bio Elpida is to become the European expert
and to bring all its expertise so that these new clinical approaches become a reality for biotechnologies and cell therapy companies and patients.
Cell Therapy is part of a new approach defined by EMEA as "Advanced Therapeutic Medicinal Product
", which could be an alternative or a complementary treatment to existing and more traditional therapies.
Cell therapy involves cells and tissues to heal and/or repair part of the human body. Regenerative medicine is part of the cell therapy and aims at achieving effective, long-term treatments for chronic diseases involving tissue and/or organ damages.
There are different ways to performing cell therapy:
- Autologous cell therapy
Autologous cell therapy uses the patient's own cells. A biopsy is taken, the cells are manipulated and expanded in the lab, and then returned to the patient. Conducting autologous cell therapy on a commercial-scale involves "scaling out" rather than scaling up; it is similar to existing procedures, such as blood transfusion, and may fit as a "bedside" procedure in the healthcare system.
- Allogeneic cell therapy
Allogeneic cell therapy uses donor cells sourced from genetically dissimilar individuals and used as a source of therapy. Allogeneic cell therapy is more akin to conventional (bio) pharmaceuticals.
- Cell therapy using cultured cells
Cultured cells therapy uses defined cell lines or expanded cell lines of the patient cells.
Although promising results have been observed in some clinical trials and a lot is expected from this new field, it is at its infancy and stronger progresses still need to be achieved. For example, cell based drug developers need to learn how to grow cells and implement the relevant immuno-assays on a commercial-scale with a quality meeting regulatory requirements.