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Development of vaccines and biopharmaceutical products


Vaccines and biopharmaceutical products are typically proteins, viruses or viral particles which require complex production systems, in most cases involving application of recombinant DNA technology. Some of these bioproducts, which are less complex in terms of post-transcription transformation (glycolyation, phosphorylation, disulphate bridges, and amidation, etc.) can be produced in yeasts or even bacteria (E. coli). However, for may other recombinant products, the quality and effectiveness of the biopharmaceutical or vaccine is only ensured if these post-transcription transformations are carried out in higher eukaryotic systems such as animal cells (mammal, human and insect).

Considering the complexity and instability of biopharmaceuticals, the production process must be designed, modeled and optimized jointly, considering the stages of culture, extraction and purification, unlike the procedures for producing other bioproducts such as antibiotics or vitamins.

IPT has accumulated experience and the necessary infrastructure to develop production processes for vaccines and biopharmaceutical products for human or veterinary use, using animal cells, in addition to products originating from microbial systems.

IPT has several cultivation systems for developing processes with animal cells (mammals and insects), from simple options whose scaling occurs through a large number of units (spinners, sollers and trays, etc.) to bioreactors (CSTR and air-lift), with volumes varying from 0.5 to 10 liters, which can be operated in discontinuous mode, fed-batch or perfusion, with free-floating cells or microcarrier cells, using animal protein-free media, as required by regulatory agencies. The analytical structure allows for monitoring of the main state variables (cells, nutrients, product and growth or production inhibitors), using chromatographic, immunochemical, electrophoretic, and other techniques specific for the products in question.


 
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