How implementation of Quality by Design and advances in Biochemical Engineering are enabling efficient bioprocess development and manufacture
✍ Scribed by Sunil Chhatre; Suzanne S. Farid; Jonathan Coffman; Paul Bird; Anthony R. Newcombe; Nigel J. Titchener-Hooker
- Publisher
- Wiley (John Wiley & Sons)
- Year
- 2011
- Tongue
- English
- Weight
- 86 KB
- Volume
- 86
- Category
- Article
- ISSN
- 0268-2575
No coin nor oath required. For personal study only.
✦ Synopsis
In recent years, Quality by Design (QbD) has gained significant prominence in the pharmaceutical industry as an efficient way of designing and controlling processes used to make therapeutic products. At its heart, QbD seeks to identify an operating envelope within which production consistently satisfies a target product quality profile and thereby achieves the desired level of safety and efficacy. Such an approach is assisted by a range of Biochemical Engineering techniques which increase process and product understanding. This perspective describes how the principles of Quality by Design and developments in the field of Biochemical Engineering are providing the pharmaceutical sector with a toolbox of methods that enable efficient bioprocess development and manufacture.