Platform Manufacturing of Biopharmaceuticals: Putting Accumulated Data and Experience to Work

01 Feb 2013

Technology and process platforms are now used extensively in the biopharmaceutical industry, both throughoutthe various phases of product development and in the facilities used tomanufacture clinical and commercial biopharmaceutical products. This document provides background information on the practical application oftechnology manufacturing platforms within the biopharmaceutical industry. While examples and references are primarilymade to proteins,the principles and approachesmay equally be applied to other biopharmaceutical product classessuch as conjugatemolecular vaccines, live viral vaccines and so on. The value of data and knowledge gathered fromplatform manufacturing or platform‐based process developmentis explored, and the advantages of the application and use of platforms, both to drug sponsors and the drug regulatory agencies, are considered.