Aplicación de métodos bioquímicos en la caracterización de antígenos vacunales, alergenos y otras biomoléculas de origen bacteriano.

Requirements of regulatory organisations for the industry are necessaries in the first stages of the investigation and development processes of biotechnological products, about validation of analytical methods that demonstrate the identity, strength, quality and purity of the products. In this work, we standardised some physical, chemical and immunochemical methods for the characterisation of molecules as antigens, allergens and some fungicide molecules. Materials and methods. Chromatography methods: a) Gel filtration in Superose 12, Sephacryl S-100, Sephacryl S-1000, Sepharose CL-4B for the determination of size of outer membrane proteins (OMP) from Vibrio cholerae, Pseudomona, Shigella, Leptospira ssp and some antigens of vaccine conjugates. Thin Layer Chromatography (TLC) for the separation of chromophore compounds from Pseudomona and for the evaluation of metabolism carbohydrates. b) Electrophoresis method in polyacylamide gels in Phast System for the antigens identity of OMP and for the evaluation of identity and amount of the allergen proteins from Dermatophagoides siboney. c) Immunochemical method. Dot Blot for the identity of antigens in vaccine conjugates. Methods were classified according to the applications recommended by OMS: Specificity, Accuracy, Precision, Linearity, Range, Robustness. Results and Conclusions. Results are adequate according with the references for that methods. It will permits security and confidence for the characterisation of molecules.