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.
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.
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.
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.
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]:
See below the processes and phases of development and manufacturing of a biopharmaceutical [1]:
Host organism selection
Host organism selection
Host organism selection
Choice of the cell or organism that will be genetically adapted to produce the desired therapeutic protein.
Choice of the cell or organism that will be genetically adapted to produce the desired therapeutic protein.
Choice of the cell or organism that will be genetically adapted to produce the desired therapeutic protein.
Gene acquisition and introduction
Gene acquisition and introduction
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.
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
Establishment of cellular banking
Establishment of cellular banking
Development of a uniform set of cells that contain recombinant DNA.
Development of a uniform set of cells that contain recombinant DNA.
Cultivation and production
Cultivation and production
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.
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
Extraction and purification
Extraction and purification
After production, the protein is isolated and purified from the cultivation medium using advanced filtration and chromatography techniques.
After production, the protein is isolated and purified from the cultivation medium using advanced filtration and chromatography techniques.
Formulation and packaging
Formulation and packaging
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.
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.
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.
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.
Reference notes
[1] EUPATI. Biologic Medicines. EUPATI. [Online] 2015/07/15. https://www.eupati.eu/types-of-medicines/biologic-medicines
[2] EMA. ICH S6 (R1) Preclinical safety evaluation of biotechnology-derived pharmaceuticals. [Online] 1997/09/30.
https://www.ema.europa.eu/en/ich-s6-r1-preclinical-safety-evaluation-biotechnology-derived-pharmaceuticals
Reference notes
[1] EUPATI. Biologic Medicines. EUPATI. [Online] 2015/07/15. https://www.eupati.eu/types-of-medicines/biologic-medicines
[2] EMA. ICH S6 (R1) Preclinical safety evaluation of biotechnology-derived pharmaceuticals. [Online] 1997/09/30.
https://www.ema.europa.eu/en/ich-s6-r1-preclinical-safety-evaluation-biotechnology-derived-pharmaceuticals
National and international partners
National and international partners
National and international partners
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 and mAbxience.
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 and mAbxience.
Bionovis is a pioneer in the production and commercialization of biological and biosimilar medicines.
Our search for scientific innovations and highly complex medicines aims to build a healthier Brazil and world for everyone.
About us
Transparency and Equal Pay Report for Women and Men
Institutional
GPDPL
Customer Service
0800 388 5000
© 2024 Bionovis. Companhia Brasileira de Biotecnologia Farmacêutica.
Bionovis is a pioneer in the production and commercialization of biological and biosimilar medicines.
Our search for scientific innovations and highly complex medicines aims to build a healthier Brazil and world for everyone.
About us
Transparency and Equal Pay Report for Women and Men
Institutional
GPDPL
Customer Service
0800 388 5000
© 2024 Bionovis. Companhia Brasileira de Biotecnologia Farmacêutica.
Bionovis is a pioneer in the production and commercialization of biological and biosimilar medicines.
Our search for scientific innovations and highly complex medicines aims to build a healthier Brazil and world for everyone.
About us
Transparency and Equal Pay Report for Women and Men
Institutional
GPDPL
Customer Service
0800 388 5000
© 2024 Bionovis. Companhia Brasileira de Biotecnologia Farmacêutica.
Bionovis is a pioneer in the production and commercialization of biological and biosimilar medicines.
Our search for scientific innovations and highly complex medicines aims to build a healthier Brazil and world for everyone.
About us
Transparency and Equal Pay Report for Women and Men
Institutional
GPDPL
Customer Service
0800 388 5000
© 2024 Bionovis. Companhia Brasileira de Biotecnologia Farmacêutica.