Blau Farmacêutica
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INVENTTA RD&I;

Blau Farmacêutica is one of the main Brazilian laboratories and one of the leaders in the hospital segment (in retail), with Footprint in Latin America, producing highly complex medications and hospital essentials. It is specialized in Oncology, Nephrology, Infectology, among others. Founded more than 30 years ago, it presents a profile of strong investment in Research and Development, with solid platforms for both Biotechnological and synthetic products, always seeking innovation in its developments and aiming to provide patients with the most modern, efficient and safe medications.

 

For expanding its position in the pharmaceutical market, Blau made high investments in a new structure for the Research and Development of Synthetic and Biotechnological Products, which was called Inventta. The Blau Farmacêutica’s Innovation, Research and Development Center allows the constancy in obtaining results and ensuring healthy and sustainable growth of the company. This center adds technology, with modern structure and equipment. The Pharmacotechnical Development has dedicated laboratories, developing new formulations of sensitizing and non-sensitizing solid products, semisolids, oral and injectable liquids, lyophilized powders and highly complex products. Its analytical structure can support the entire Pharmacotechnical Development process, from the design of the project to its launch.

It presents a dedicated Pre-Formulation area and an equipment park with modern analytical techniques. Inventta has an installed capacity for simultaneous work of 60 different projects, and in different phases, with the possibility of increasing 15 new projects each year, as well as the capacity to make 15 new dossiers available annually for regulatory submission to ANVISA. 

Inventta has highly trained professionals, distributed in the following areas:

• Pre-formulation
• Technical Documentation
• DMF (Drug Master File)
• Analytical Development
• Development of Synthetic Products
• Development of Biotechnological Products
• Development of Packaging Materials
• Technical Support for Portfolio Products
• PMO (Project Management Office)

Blau Farmacêutica’s R&D team has received a strong increase and currently includes more than 120 professionals, including masters and doctors in many specialties.

Training, Qualification and Regulation

Aiming to develop specialists and raise the level of qualification of the teams, it maintains external and internal training programs promoting the exchange and multiplication of knowledge. The entire team is integrated and aligned with the company’s mission, vision, and values.

All phases of the projects are carried out in compliance with the Good Manufacturing Practices, from the assessment of suppliers, preparation of documents, to the manufacture of pilot batches, in addition to keeping the work safety and protection laws strictly implemented that ensure the well-being and health of all employees.

The developments carried out by Blau consider all possible alternatives so that the environment is impacted in the least possible way, meeting 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.

 

Working together with the New Business, Marketing and Market Intelligence areas provides information and the ability to map market needs and partnership opportunities to build your pipeline.Blau Farmacêutica’s pipeline is directed towards the development of

products that will complete the wide range of existing items and the treatment of diseases in the areas of oncology, microbial infections and other therapeutic classes, such as, for example, antibiotics, antifungals, antivirals, among others. The choice of molecules aims to provide patients and doctors with alternative treatments that contribute in order to ensure accessibility, health and well-being to the greatest number of people. 

Blau has a plant dedicated to the production of oncological medications and great expertise in this segment, which inserts a greater number of products of this line in the pipeline under development, also investing in new pre-formulation processes and technologies, which ensures a higher level of assertiveness in the development and compliance with the schedules, which are lean and challenging. It also has specialized equipment in the prediction and definition of lyophilization processes in the development phase, including bench lyophilizer and lyophilization microscope.

The team of support professionals seeks continuous improvement of the portfolio, ensuring the life cycle of products already established within the most demanding quality standards in the market and health authorities.

 

The use of tools for monitoring publications and updates from regulatory bodies, such as ANVISA and others, keeps the teams constantly updated, seeking to be as close as possible to them, aiming to expand and raise the level of technical discussions, ensuring the quality of the processes of registration and following regulatory trends.

 

Blau has been selling biological products for approximately 30 years in the national market and was the pioneer company in the manufacture of biotechnological medications 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 these medications and has been operating in this segment for over 10 years.

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

The area responsible for the development of active pharmaceutical ingredients (API) and biological and biotechnological products has a team of highly qualified professionals that is composed of masters and doctors, all with extensive experience in the development of highly complex molecules and products. 

The process of developing biotechnological ingredients (recombinant human proteins) through obtaining genetically modified prokaryotic and eukaryotic cell lines is carried out in the Blau Farmacêutica’s research and development laboratories. The cell culture and fermentation and purification processes to obtain human recombinant proteins are carried out at different productive scales until their industrial scale in a modern plant with bioreactors (upstream) and preparative chromatography systems (downstream). The stages of industrial development and scheduling demand strict controls of processes and products using state-of-the-art analytical instruments and the latest technology, in addition to internationally known partners. The technical documentation of the development processes and biological pharmaceutical ingredients are built in order to comply with all regulations and requirements of Regulatory Agencies in Brazil, Europe and the USA, with the availability of DMFs.

Blau’s biological and biotechnological product line has its focus on the development of related biotechnological products.  This process is highly complex and requires technology, work, effort and investment in a period that can vary between 7 and 9 years of total dedication. The projects require great training and technical updating of the team involved and include phases, such as obtaining recombinant strains of prokaryotic and eukaryotic cells, which will produce the medications, taking into account the characterization of these products and clinical research. In case of biological products, the operational and technological challenges in the production of molecules of high complexity and high molecular weight are related to the use of live production systems, with specific propagation and maintenance requirements. The development flow involves the physical-chemical, biochemical and functional characterization of the molecule, as well as the attributes of quality and comparability in relation to comparator biological products and are carried out with a high technical and scientific level, aiming to meet all requirements of national regulatory agencies and international.