RESUMEN
The antigenicity of alum-adsorbed diphtheria toxoid (DTd) was determined in combination vaccines, containing DTd, tetanus toxoid and inactivated poliovirus. A panel of monoclonal antibodies was used, covering five epitopes, distributed over the antigen. The resulting antigenic fingerprint of DTd demonstrates consistency of adsorption at antigen level in final product combination vaccines. The antigenic quality of DTd alone, adsorbed to aluminium phosphate, was also determined and compared with pre-adsorbed toxoid (starting material as well as toxoid desorbed from aluminium phosphate). Some epitopes became less accessible after adsorption, while others became relatively better exposed. Some epitopes disappeared almost completely upon adsorption, but were re-established after desorption of the antigen. The results indicate that DTd is adsorbed to aluminium phosphate in a preferred orientation and not randomly.
Asunto(s)
Compuestos de Aluminio/química , Anticuerpos Antibacterianos/química , Anticuerpos Monoclonales de Origen Murino/química , Antígenos Bacterianos/química , Toxoide Diftérico/química , Fosfatos/química , Inmunogenicidad VacunalRESUMEN
The successful development of vaccines is a lengthy process, requiring input from different expertises, such as research and development, quality control, quality assurance, production, regulatory affairs, and marketing and sales. A cornerstone in vaccine development is the availability of a panel of high-quality assays that can reduce the risk of failure in clinical trials and licensure. This review highlights the quality-control issues and approaches in vaccine development from different viewpoints: discovery, process development, assay development, clinical development and the postlicensing phase.
