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PAT applied in biopharmaceutical process development and manufacturing : an enabling tool for quality-by-design /
"This book summarizes the state of the art in process analytical technologies applied to various aspects of biopharmaceutical process development and manufacturing. The text summarizes regulatory perspectives, FDA/EMEA guidelines, and new expectations. In addition, it explores new technology, e...
| Clasificación: | Libro Electrónico |
|---|---|
| Otros Autores: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Boca Raton, Fla. :
CRC Press,
©2012.
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| Colección: | Biotechnology and bioprocessing series ;
33. |
| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- Ch. 1. Scientific and regulatory overview of process analytical technology in bioprocess / Rakhi B. Shah [and others]
- ch. 2. Strategic vision for integrated process analytical technology and advanced control in biologics manufacturing / Melissa M. St. Amand [and others]
- ch. 3. Multivariate techniques in biopharmaceutical process development / Jeremy S. Conner
- ch. 4. Analysis, monitoring, control, and optimization of batch processes : multivariate dynamic data modeling / Theodora Kourti
- ch. 5. Multivariate data analysis in biopharmaceuticals / Joydeep Ganguly [and others]
- ch. 6. Process analytical technology advances and applications in recombinant protein cell culture processes / Ana Veronica Carvalhal and Victor M. Saucedo
- ch. 7. Process analytical technology applied to raw materials / Erik Skibsted
- ch. 8. Process analysis technology for enhanced verification of bioprocess system cleaning / Peter K. Watler [and others]
- ch. 9. Cell culture process analytical technology multiplexing near-infrared / Mariana L. Fazenda, Linda M. Harvey, and Brian McNeil
- ch. 10. Process analytical technology for bioseparation unit operations / Anurag S. Rathore, Vishal Ghare, and Rahul Bhambure
- ch. 11. Process analytical technology use in biofuels manufacturing / Pedro Felizardo, José C. Menezes, and M. Joana Neiva-Correia
- ch. 12. Application of microreactors for innovative bioprocess development and manufacturing / Seth T. Rodgers and A. Peter Russo
- ch. 13. Real-time monitoring and controlling of lyophilization process parameters through process analytical technology tools / Feroz Jameel and William J. Kessler
- ch. 14. Process analytical technology's role in operational excellence / Fetanet Ceylan Erzen and Manbir Sodhi
- ch. 15. Conclusions, current status, and future vision of process analytical technology in biologics / Duncan Low and Ray Chrisman.