Platform Manufacturing of Biopharmaceuticals: Putting Accumulated Data and Experience to Work
Technology and process platforms are now used extensively in the biopharmaceutical industry, both throughout the various phases of product development and in the facilities used to manufacture clinical and commercial biopharmaceutical products.
This document provides background information on the practical application of technology manufacturing platforms within the biopharmaceutical industry. While examples and references are primarily made to proteins, the principles and approaches may equally be applied to other biopharmaceutical product classes such as conjugate molecular vaccines, live viral vaccines and so on. The value of data and knowledge gathered from platform manufacturing or platform-based process development is explored, and the advantages of the application and use of platforms, both to drug sponsors and the drug regulatory agencies, are considered.