Resumo

SORIA OSORIO, Raúl; MENESES-ACOSTA, Angélica  e  PANIAGUA SOLIS, Jorge F.. Space Design during the development of biopharmaceuticals. Rev. mex. cienc. farm [online]. 2011, vol.42, n.1, pp.58-64. ISSN 1870-0195.

The development of the biopharmaceuticals processes is showing transition due to a great amount of regulations and to the extent of applications generated by the biotechnology. Hence, the introduction of the design space concept in the biopharmaceuticals development has brought a greater significance in the last few years after the International Conference of Harmonization issued in 2009, the second version of the ICH Q8 (R2) Guide that contains the concept general specifications. This Guide provides current directives for the elaboration of the pharmaceutical development stages reports in order to promote, among the biopharmaceuticals manufacturers, the inclusion of comprehensive studies for drug substance, drug product and manufacturing process based on a risk analysis in order to assure the products quality in a systematized basis.

Palavras-chave : space design; biopharmaceuticals; harmonisation.