Through the research and development of biological and biosimilar medicines, Bionovis works with the goal of producing highly complex drugs and expanding access to treatments for the entire population.
Developing a biopharmaceutical requires extensive research and significant investment. Unlike synthetic medicines, the active ingredient in a biological medicine is a substance derived from living cells.
Selection of the cell or organism that will be genetically adapted to produce the desired therapeutic protein.
Identification of the gene responsible for producing the target protein. This gene is then inserted into the host organism, combining with its DNA.
Creation of a uniform set of cells that contain recombinant DNA.
The process begins by thawing the stored cells and cultivating them on increasingly larger scales until reaching the ideal volume in the bioreactor. During this stage, the cells are optimized to produce and release the desired therapeutic proteins.
After production, the protein is isolated and purified from the culture medium using advanced filtration and chromatography techniques.
With the support of Bionovis’ quality control laboratory, each product is formulated, bottled, and tested to ensure compliance with the rigorous standards established by ANVISA and other global regulatory authorities.
It is important to emphasize that, in the development process of biopharmaceutical, non-clinical studies — both in vitro and in vivo — are essential to ensure the safety and efficacy of the medicine [2]. Due to the complex nature of protein molecules, biological medicines cannot be copied identically, but they can be replicated as equivalents, known as biosimilars.
In over more than a decade of operation, we have built partnerships with major global leaders in the pharmaceutical sector and public laboratories, such as: Bio-Manguinhos/FIOCRUZ, Fresenius Kabi, Johnson & Johnson, Merck, Samsung Bioepis and Sandoz. Through these partnerships, we receive the complete technology for the production of innovative biopharmaceuticals and biosimilars.
In addition, we have signed partnerships for commercialization in the private market, with INTAS, mAbxience and Samsung Bioepis.
Bionovis is a pioneer in the production and commercialization of biological and biosimilar medicines.
Our pursuit of scientific innovations and highly complex medicines aims to build a healthier Brazil — and a healthier world — for everyone.
© 2025 Bionovis. Companhia Brasileira de Biotecnologia Farmacêutica.
