TECHNOLOGICAL DEVELOPMENT

We develop bioproducts using genetic engineering and biotechnology techniques, and we work on the continuous improvement of the products marketed by the Center for Genetic Engineering and Biotechnology. The technological development process includes the establishment of technologies in laboratories, with all the required quality parameters, governed by an integrated project management methodology, which guarantees adequate planning of the objectives and a systematic review of their progress. To do this, we combine good manufacturing practices (GMP) and good laboratory practices (GLP) and maintain a documented quality system that provides the highest quality and safety of the products and technologies that we are developing. Among the activities we carry out are:

• Development and optimization of fermentation processes
• Production of pilot batches
• Reengineering of existing fermentation processes
• Process integration for improvements of productivity
• Modeling and simulation of downstream processes
• Optimization and analysis of experiments using the QbD methodology
• Methods of cell disruption of microorganisms
• Methods for primary purification, including precipitation and liquid-liquid extraction
• Preventive and therapeutic development of combined vaccines
• Pegylation of biomolecules
• Encapsulation in microspheres of proteins and peptides
• Establishment of analytical methodology for the stability of intermediate studies and final products
• Development of technological packages for technology transfer, request for approval of clinical trials and registration of new products
• Assurance of compliance use of good laboratory and production practices during technology development and pilot batch production.