THE COMPANY
Blau Farmacêutica is one of the main Brazilian laboratories and one of the leaders in the hospital segment (retail), with a continental footprint, producing highly complex and essential drugs for hospital routine. Blau specializes in Oncology, Nephrology, Infectology, among others.
Founded over 36 years ago, the company has a strong investment profile in Research, Development and Innovation, with robust platforms, whether for biotechnological or synthetic drugs, always seeking innovation in its developments, aiming to provide doctors and patients with the most modern, efficient and safe medicines.
RESEARCH, DEVELOPMENT AND INNOVATION CENTER
Aiming to expand its position in the pharmaceutical market, Blau constantly invests in Inventta, which is its Research, Development and Innovation Center for Synthetic Drugs, Biological Drugs and APIs and Biotechnological Drugs, which allows for excellence in obtaining results and a healthy and sustainable growth for the company.
Said center combines scientific knowledge and modern technological structure, with laboratories dedicated to highly complex formulations, such as sensitizing and non-sensitizing solid products, lyophilized drugs, solutions and suspensions for injections, semi-solids, among other pharmaceutical forms.
This center has high analytical processing capacity, used in all phases of drug development and a proteomics area for biological characterization of active pharmaceutical ingredients.
Inventta has highly qualified professionals, allocated in the following areas:
- Innovation and Patents
- Preformulation
- DMF (Drug Master File)
- Proteomics
- Analytical Development
- Microbiological Development, including Potency Tests in Cellular Models
- Formulation Development
- Bioprocess Development for Biotechnological API
- Development of Packaging Materials
- Technical Support for Portfolio Products
- Technical Documentation
Blau Farmacêutica’s R&D team currently has over 160 researchers, with an average of 30 professionals holding master's and/or PhD degrees, in several specialties.
Project governance is carried out by the PMO (Project Management Office) team, which coordinates the integration of teams in managing projects and completing deliverables, supporting the company in strategic decisions to achieve planned targets.
This structure has been delivering great results for the company, with the ongoing development of new products and a growing number of new drugs in the Portfolio. In the last three years, we have launched 27 new highly complex molecules on the Brazilian market, totaling 39 concentrations, including generic, biosimilar and private label drugs. In the same period, we launched 25 products, corresponding to 31 concentrations. We have a consistent plan every year to launch new products developed at Inventta for the Brazilian and Latin American markets.
BIOLOGICAL AND BIOTECHNOLOGICAL PRODUCTS
Blau has been selling biological products in the domestic market for approximately 30 years and was the pioneering company in the production of biotechnological drugs in Brazil. Following the current trend in the development of treatments based on drugs obtained from biotechnology techniques, Blau has developed an exclusive platform for the development and production of said drugs and has been operating in this segment for over 10 years.
Blau also invests in including molecules that provide diverse, cutting-edge treatments in its pipeline.
The process of developing biotechnological inputs (recombinant human proteins) by obtaining genetically modified prokaryotic and eukaryotic cell lines is carried out in Blau Farmacêutica’s research and development laboratories.
The Biotech R&D team develops bioprocesses, including cell culture in mammalian cells and fermentation of prokaryotic cells, in addition to purification to obtain recombinant human proteins, which are carried out in a development environment and subsequently scaled up for the industrial area in a modern plant with bioreactors (upstream) and preparative chromatography systems (downstream). The steps of industrial development and scaling require strict controls of processes and products using state-of-the-art analytical instruments and cutting-edge technology, in addition to internationally known partners. The technical documentation of the development processes and biological pharmaceutical inputs are developed in such a way as to comply with all regulations and requirements of Regulatory Agencies in Brazil, Europe and the USA, with the provision of DMFs.
Blau’s pipeline of biological and biotechnology products is focused on the development of next-generation biotechnology biosimilar products, including monoclonal antibodies. This process is highly complex and demands technology, work, effort and investment over a period that can vary from 7 to 10 years, to complete the development of the API and the biosimilar drug.
Blau is one of the few companies capable of developing the full chain of a biotechnological drug, from the development and production of the API to the finished product.
The development flow involves the physical-chemical, biochemical and functional characterization of the molecule, as well as the quality and comparability attributes regarding the comparability of biological products and is conducted with a high technical and scientific level, aiming to meet all the requirements of domestic and foreign regulatory agencies.
Blau is also investing in the development of monoclonal antibodies, extremely specific drugs with high added value, which normally exist on the Brazilian market as licensed products. In recent decades, there has been a significant increase in clinical studies for potential applications of monoclonal antibodies for the treatment of several types of cancer and autoimmune diseases, evidencing a trend for this class of drugs as the main therapeutic agent. The company will be one of the few corporations to produce monoclonal antibody’s IFA and biosimilar drugs on national soil.
With advances in basic and clinical research in the search for new therapeutic targets for oncology and autoimmune diseases, monoclonal antibodies have been consolidating themselves as an important class of drugs. An important highlight of this class of drugs is their high affinity with their targets, causing fewer side effects, a characteristic that represents a great advantage over traditional treatments, such as radiotherapy and chemotherapy in the treatment of cancers.
The launch of these drugs will be a milestone in the history of Blau and Brazil, which will have a national manufacturer developing and producing APIs and biosimilar drugs locally. This initiative will give the population greater access to advanced drugs and reinforce Blau’s willingness to become a benchmark in the production of biosimilars in Latin America.
The developments carried out by Blau consider all possible alternatives, so that there is the least impact on the environment, following the company’s ESG policy, fulfilling its role of environmental responsibility in society.
All products are developed in compliance with the regulations required in Brazil and other countries to which the company exports its products.
