R&D

The Company
Blau Pharmaceuticals is one of Brazil’s main laboratories, and one of the leaders in the hospital sector (in retail), with direct operations in Latin America’s main countries and markets.

It manufactures high complexity and essential hospital drugs and is specialized in Oncology, Nephrology, Infectiology, among others.

With headquarters and production plants in São Paulo - Brazil and subsidiaries in Uruguay, Argentina, Chile, Colombia and Peru, as well as partnerships in other countries such as Ecuador and Bolivia, it showcases thereby a broad range of operation in the Central American region.

Established for over 30 years, Blau Pharmaceuticals has a strong R&D investment profile, with robust platforms, both for biotechnological and synthetic products, always pursuing innovation in its developments, aiming at providing patients with the most modern, efficient and safe medicines that can be offered.

The Development
In order to maintain and expand its position in the pharmaceutical market, and ahead of its main competitors, Blau has invested heavily in the construction of a new structure for Research and Development of Synthetic and Biotechnological Products, with a wide area dedicated to the development of formulations of semisolids, oral liquids, injectables, freeze-dried powders and sensitizing and non-sensitizing solids. It also has an analytical structure able to supporting the entire process of galenic development, from project design to its release.

The Blau Farmaceutica's Product Development and Research Center has highly trained professionals in the following areas: • Preformulation
• Technical Documentation
• DMF (Drug Master File)
• Analytical Development
• Development of Synthetic Products
• Development of Biotech Products
• Development of Packaging Materials
• Technical Support for Portfolio Products
• PMO (Project Management Office)

Training, Qualification and Regulation
With the purpose of developing specialists and raising the level of qualification of the teams, we have an external and internal training program that encourages and fosters the exchange and multiplication of knowledge.

The entire team is engaged and aligned with the mission, vision and values of the company, in the sense of providing new products that provide and ensure the health, quality of life and longevity of people; thus, we encourage team spirit, ownership and execution of tasks with quality, efficiency, boldness and integrity.

All phases of the project are conducted according to Good Manufacturing Practices, from supplier evaluation, document preparation, to the production of pilot batches. The labor protection and safety rules are closely complied with, ensuring the well-being and health of all employees.

In the prospection of materials for the composition of the products, Blau considers all the alternatives, so that the smallest possible impact to the environment occurs, fulfilling its role of environmental responsibility in society.

All products are developed in compliance with the regulations required in Brazil and also in other countries, where the company exports its products, such as: Uruguay, Argentina, Peru, Colombia, Ecuador, Costa Rica and others, ensuring that Blau is aligned with its goal of becoming the Leading pharmaceutical company in the Latin American market.

Focus on Performance
We work jointly with the New Business and Market Intelligence areas that have information and expertise to map market needs and opportunities for partnerships, in order to build the company´s pipeline.

Blau Farmaceutica's pipeline is strongly focused on the development of products that can complete the wide basket of products for the treatment of diseases in the areas of oncology, microbial infections and other therapeutic classes, such as antibiotics, antifungal, antiviral, among others. The choice of molecules aims to provide patients and doctors with new treatment alternatives that contribute to ensure accessibility, health and well-being for as many people as possible.

Blau has a plant dedicated to the production of oncological medications, and great expertise in this field, which inserts a higher number of products of this line in the pipeline under development.

Blau invests in new processes and technologies of Preformulation, which ensures a higher level of assertiveness in the development and the fulfillment of the schedules, that are characterised as lean and challenging.

The company counts on specialized equipment in the prediction and design of freeze-drying processes in the development phase, including the bench lyophilizer and the freeze-drying microscope.

The team of support professionals seeks to continuously improve this portfolio, ensuring the life cycle of products already established and known by Medical Physicians, within the most demanding quality standards established by the market and sanitary authorities

Trends
We have tools to monitor the publications and updates of regulatory agencies, such as ANVISA and others, which keeps the teams constantly updated, because we seek to closely follow the regulatory agencies, aiming at expand and raise the level of technical discussions, ensuring the quality of registration processes and following regulatory trends.

Biological and Biotechnological Products
In line with the current global trend of development and offering of treatments based on medicines obtained from biotechnology techniques, Blau has created a unique platform for the development and production of these medicines and operates in this field for more than 10 years, having been the pioneer in the production of biotechnological medicines in Brazil

Blau invests in the inclusion of molecules in its Pipeline which will provide various treatments for rare and neglected diseases, that reach a broad and specific population group.

The area responsible for the development of active pharmaceutical ingredients (IFA) and Biological and Biotechnological products, has a team of highly skilled professionals, comprised by holders of master’s degree and doctorates, with extensive experience in developing molecules and high-complexity products.

The development process of biotechnological inputs (human recombinant proteins), by obtaining lines of genetically modified eukaryotic and prokaryotic cells is carried out in the research and development laboratories of Blau Farmacêutica. The fermentation of cells to produce recombinant human proteins is performed in a State-Of-the-Art plant with bioreactors (upstream), and preparative chromatographic systems for purification (downstream), which offer strict process and product controls, using state-of-the-art analytical instruments, use of state-of-the-art technologies and internationally known partners that guarantee the quality of biotechnological products.

The technical documentation of development processes and biological pharmaceutical inputs are being built to comply with all regulations of Regulatory Agencies, such as ANVISA, FDA and EMA and with the availability of DMFs, in accordance with these requirements.

In the line of Biological and Biotechnological products, Blau is focused on the development of Biosimilar products. This development process is extremely complex, and demands technology, work, effort and investment in a period ranging from 7 to 9 years of total dedication.

The project also requires great training and technical updating from the team engaged, and includes steps such as obtaining prokaryotic and eukaryotic cells, which will produce the medications, the characterization of the biosimilar product and clinical research.

In the case of biological products, the molecules are much larger and complex, when compared to synthetic medications, which adds a degree of complexity to the process, in relation to the physical chemical features of these products, as well as the quality attributes, compared to the biocomparator medications. These developments are carried out with a high technical and scientific level, and aim at the application for registration of biosimilar medications with the regulatory agencies, such as ANVISA and other international agencies.



Português Inglês Espanhol Espanhol
+
+