The Technological Development Division (TDD) of CGEB has the mission to develop Bio-products using techniques of genetic engineering and biotechnology. He also works on the continuous improvement of products marketed by Heber Biotec. The whole process of development includes the establishment of technologies in laboratories with all the required quality parameters. It is governed by a methodology of integrated management of the projects, which guarantees an adequate planning of the objectives and a systematic review of its progress.
Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLPs) are combined and maintained in a documented quality system that provides the highest quality and safety of the products and technologies being developed.
To guarantee its mission, DTD has the support of specialized laboratories in microbiology, fermentation of microorganisms, purification of biomolecules, formulation, analytical methods and a pilot plant for the production of small scale batches. It also has a well trained staff, made up of scientists and technologists with experience in different aspects of modern biotechnology including: genetic modification of microorganisms, fermentation of bacteria and yeasts, cell cultures of higher organisms, purification of proteins and other molecules, formulation and Stability tests and development of analytical techniques.
The main activities that are developed in the area:
- Development and optimization of fermentation processes
- Production of pilot batches
- Reengineering of existing fermentation processes
- Integration of processes for productivity improvements
- 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 an analytical methodology for the stability of intermediate and final product studies.
- Development of technological packages for the transfer of technology, request for approval of clinical trials and registration of new products.
- Ensuring compliance with Good Laboratory and Production Practices during technology development and production of pilot lots.