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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.
|
| Colección: | Biotechnology and bioprocessing series ;
33. |
| Temas: | |
| Acceso en línea: | Texto completo |
MARC
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| 245 | 0 | 0 | |a PAT applied in biopharmaceutical process development and manufacturing : |b an enabling tool for quality-by-design / |c edited by Cenk Undey [and others]. |
| 260 | |a Boca Raton, Fla. : |b CRC Press, |c ©2012. | ||
| 300 | |a 1 online resource. | ||
| 336 | |a text |b txt |2 rdacontent | ||
| 337 | |a computer |b c |2 rdamedia | ||
| 338 | |a online resource |b cr |2 rdacarrier | ||
| 490 | 1 | |a Biotechnology and bioprocessing series ; |v 33 | |
| 520 | |a "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, especially in the area of real-time monitoring for end-point control as well as new sensor and analytical technologies. It details established and emerging measurement technologies, including future needs and challenges that require further research. The authors also present successful industrial-scale deployment case studies and strategies from the biopharmaceutical industry and discuss future trends." | ||
| 504 | |a Includes bibliographical references and index. | ||
| 505 | 0 | |a 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. | |
| 590 | |a ProQuest Ebook Central |b Ebook Central Academic Complete | ||
| 650 | 0 | |a Pharmaceutical biotechnology. | |
| 650 | 0 | |a Biopharmaceutics. | |
| 650 | 0 | |a Drug development. | |
| 650 | 0 | |a Drugs. | |
| 650 | 1 | 2 | |a Pharmaceutical Preparations |
| 650 | 1 | 2 | |a Biopharmaceutics |x methods |
| 650 | 2 | 2 | |a Drug Compounding |
| 650 | 2 | 2 | |a Technology, Pharmaceutical |x standards |
| 650 | 2 | |a Biopharmaceutics | |
| 650 | 6 | |a Biotechnologie pharmaceutique. | |
| 650 | 6 | |a Biopharmacie. | |
| 650 | 6 | |a Médicaments |x Développement. | |
| 650 | 6 | |a Médicaments. | |
| 650 | 7 | |a MEDICAL |x Drug Guides. |2 bisacsh | |
| 650 | 7 | |a MEDICAL |x Nursing |x Pharmacology. |2 bisacsh | |
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| 650 | 7 | |a Pharmaceutical biotechnology |2 fast | |
| 650 | 7 | |a Pharmazeutische Technologie. |2 idszbz | |
| 650 | 7 | |a Pharmazeutische Biologie. |2 idszbz | |
| 650 | 7 | |a Arzneimittel. |2 idszbz | |
| 650 | 7 | |a Forschung und Entwicklung. |2 idszbz | |
| 700 | 1 | |a Undey, Cenk. | |
| 758 | |i has work: |a PAT applied in biopharmaceutical process development and manufacturing (Text) |1 https://id.oclc.org/worldcat/entity/E39PCFVfYJV34RV4D7tjHPVKkC |4 https://id.oclc.org/worldcat/ontology/hasWork | ||
| 776 | 0 | 8 | |i Print version: |t PAT applied in biopharmaceutical process development and manufacturing. |d Boca Raton, Fla. : CRC Press, ©2012 |z 9781439829455 |z 1439829454 |w (DLC) 2011031862 |w (OCoLC)746489188 |
| 830 | 0 | |a Biotechnology and bioprocessing series ; |v 33. | |
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