Introduction

The manufacture of pharmaceutical substances is one of the most highly regulated and rigorously controlled of manufacturing processes. In order to gain a manufacturing licence, the producer must prove to the regulatory authorities that not only is the product itself safe and effective, but that all aspects of the proposed manufacturing process comply with the highest safety and quality standards.

This chapter aims to overview the manufacturing process of therapeutic proteins. It concerns itself with two major themes: (1) sources of biopharmaceuticals and (2) upstream processing. The additional elements of biopharmaceutical manufacturing, i.e. downstream processing and product analysis, are discussed in Chapters 6 and 7 respectively.

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