Bioinova, a.s.

COMPANY PROFILE

Main focus of the company is the bench-to-bedside RnD of advanced therapy medicinal products (ATMPs) based on stem cells from different somatic and extra-foetal tissues for regenerative medicine and tissue engineering. As a certified manufacturer of ATMPs under GMP, Bioinova has state-of-art manufacturing facilities for aseptic processes (cleanrooms class A/B). for regenerative medicine and tissue engineering. Bioinova also performs clinical trials with cell therapy products. Within the green smart cities sector, Bioinova contributes to improving the quality of life of the population and supporting the environment. Bioinova is also active in molecular diagnostics and develops novel in vitro diagnostic tools.

PRODUCTS & SERVICES

Bioinova, s.r.o. offers products in the evaluation regime of medicinal products, or products intended for clinical trials such as

• BiCure® ortho MSCp (MSCs in autologous plasma in combination with a 3D scaffold for orthopaedic indications)
• BiCure® ophtalmo MSCs (MSCs for retinal diseases)
• BiCureSol® (clinical grade solution for cell storage and transportation)
• Bi-CoVTM set (set for biological material sampling and RAN isolation)
• BiCureS

Services include, for example

• Consulting services in SVP activities
• Tests for sterility - by the method of direct vaccination according to the valid Pharmacopoeia (Articles 2.6.1 and 2.6.27) with the possibility of using an alternative determination on the Bact/ALERT device, including relevant validations
• Phenotyping of cells by flow cytometry
• Contract manufacturing of medicinal products of modern therapy (LPMT) for clinical trials