## Abstract Implementing realβtime product quality control meets one or both of the key goals outlined in FDA's PAT guidance: βvariability is managed by the processβ and βproduct quality attributes can be accurately and reliably predicted over the design space established for materials used, proces
Process analytical technology (PAT) for biopharmaceutical products: Part I. concepts and applications
β Scribed by E.K. Read; J.T. Park; R.B. Shah; B.S. Riley; K.A. Brorson; A.S. Rathore
- Publisher
- John Wiley and Sons
- Year
- 2010
- Tongue
- English
- Weight
- 194 KB
- Volume
- 105
- Category
- Article
- ISSN
- 0006-3592
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## Abstract Process analytical technology (PAT) has been gaining a lot of momentum in the biopharmaceutical community due to the potential for continuous realβtime quality assurance resulting in improved operational control and compliance. Two of the key goals that have been outlined for PAT are βv