Bioinova
Czech Biotechnology Company
We are a Czech biotechnology company based in Prague primarily dedicated to research and development of novel stem cell-based therapies.
We develop advanced therapy medicinal products (ATMPs) based on stem and other cells obtained and cultured from bone marrow as well as adipose and other tissues. Bioinova is a certified producer of ATMPs. The safety and efficacy of our products are evaluated in preclinical studies and own clinical trials. We combine and test our products with commercially available as well as own biomaterials (including nanomaterials) to further enhance their efficacy and to open new avenues in the field of regenerative medicine and tissue engineering. We also commercially use the cell products in fields that do not require clinical trials.
Our production is conducted in facilities for aseptic processes class A/B and our team consists of highly qualified experts with experience from worldwide leading research institutions.
Goals
Our priority is to provide the patients with innovative, safe, efficient and affordable therapeutic methods in various areas of regenerative medicine and tissue engineering.
To achieve that, we combine great ideas with high-tech equipment, hard work and strong partners.
Our goal is to flexibly respond to scientific advancement and to shape the future of tissue regeneration and applied biomedical engineering fields.
History
Bioinova was founded in 2008 as a spin-off company of the Institute of Experimental Medicine of the Czech Academy of Sciences to increase the application potential of the innovations and the technology transfer efficiency to clinical practice.
In 2010, Bioinova has been approved by the State Institute for Drug Control (SITC) for aseptic production of medicinal products based on mesenchymal stem cells from bone marrow for clinical trials. The production is performed in clean rooms class A/B in compliance with Good Manufacturing Practice (GMP) guidelines.
Investors had gradually entered the company and in 2016, Bioinova became completely private while it has initiated its own research and development. Bioinova has established numerous scientific and industrial collaborations with leading academic institutions, hospitals and high-tech companies in the Czech Republic as well as abroad in terms of biomedical research, translational medicine and clinical practice.
GMP Certificate
Issued by State Institute for Drug Control according to Article 63 (4) of Regulation (EU) No 536/2014 in 2022.
Change of Tissue Establishment Operation in 2019
State Institute for Drug Control, in accordance with § 20 paragraph 1 of the Law on human tissues and cells, changes the authorization of the Tissue Establishment operation; issued on March 16, 2018, doc. number: sukls142047/2018.
