Research and Development

Through research and development of biologicals and biosimilars, Bionovis works with the objective of producing highly complex medicines 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.

See below the processes and phases of development and manufacturing of a biopharmaceutical [1]:

Host organism selection

Choice of the cell or organism that will be genetically adapted to produce the desired therapeutic protein.

Gene acquisition and introduction

Capture of the gene responsible for the production of the target protein. Subsequently, this gene is inserted into the host organism, combining with its DNA.

Establishment of cellular banking

Development of a uniform set of cells that contain recombinant DNA.

Cultivation and production

The process begins by thawing the stored cells, cultivating them on increasing scales until reaching the ideal volume in the bioreactor. During this step, cells are optimized to produce and release the desired therapeutic proteins.

Extraction and purification

After production, the protein is isolated and purified from the cultivation medium using advanced filtration and chromatography techniques.

Formulation and packaging

With the support of Bionovis’ quality control laboratory, each product is formulated, bottled and tested to ensure it meets the rigorous standards established by ANVISA and other global regulatory authorities.

It is important to highlight that in the process of developing a biopharmaceutical, non-clinical studies, both in vitro and in vivo, are essential to guarantee the safety and efficacy of the medicine [2]. Due to the intricate nature of protein molecules, biologic medicines cannot be copied identically, but can be replicated as equivalents, known as biosimilars.

National and international partners

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 Innovative Medicine, 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.