Advances in PAT for Parenteral Drug Manufacturing - Pharmaceutical Technology

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Advances in PAT for Parenteral Drug Manufacturing
Applying quality-by-design and process analytical technology facilitates process understanding and control of various operations in lyophilization.


Pharmaceutical Technology
Volume 37, Issue 3, pp. 38-43

Other approaches

Researchers recently implemented and evaluated an optical-fiber system as a process-monitoring tool during lyophilization. The study recorded temperature profiles of mannitol, sucrose, and trehalose using various prototypes of optical fiber sensors (OFSs) (14). The data were compared to data obtained with conventional thermocouples or Pirani/capacitance manometry with respect to the endpoint of primary drying. The researchers reported that the data obtained with the OFS in contact with product were in good agreement with data obtained by thermocouples or Pirani/capacitance manometry. The OFSs showed higher sensitivity, faster response, and better resolution compared to thermocouples (14). Another study examined the use of a soft sensor for in-line monitoring of the primary drying step of a freeze-drying process in vials (15).

References

1. FDA, Pharmaceutical CGMPs for the 21st Century—Risk-Based Approach: Final Report (Rockville, MD, 2004).

2. FDA, Guidance for Industry: PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance (Rockville, MD, 2004).

3. FDA, Progress Report on Process Analytical Technology, http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/QuestionsandAnswer-sonCurrentGoodManufacturingPrac-ticescGMPforDrugs/ucm072006.htm, accessed Feb. 13, 2013.

4. P. Van Arnum, Pharm. Technol. 36 (9), 38-40 (2012).

5. F. Jameel and W.J. Kessler, "Real-time Monitoring and Controlling of Lyophillization Process Parameters Through Process Analytical Technology Tools," in PAT Applied in Biopharmaceutical Process Development and Manufacturing: An Enabling Tool for Quality by Design, C. Undey et al., Eds. (CRC Press, Taylor & France, Boca Raton, FL, 2012), pp. 241-243.

6. R.B. Shah et al., "Scientific and Regulatory Overview of Process Analytical Technology in BioProcesses," in PAT Applied in Biopharmaceutical Process Development and Manufacturing: An Enabling Tool for Quality by Design, C. Undey et al., Eds. (CRC Press, Taylor & France, Boca Raton, FL 2012), p. 5.

7. D. Sesholtz and L. Mather, "'Smart Freeze Drying," Innovation in Pharm. Technol., http://www.biopharma.co.uk/wp-content/uploads/2010/07/Smart_Freezedrying_article_2007, accessed Feb. 13, 2013.

8. . Shon, "Optimization of Primary Freeze-Drying Cycle Times," Innovation in Pharm. Technol., http://www.iptonline.com/pdf_viewarticle.asp?cat=7&article=887, accessed Feb. 13, 2013.

9. .C. Schneid and H. Giessler, AAPS PhamSciTech. 9 (3), 729-739 (2008).

10. .R.M. De Beer et al., J. Pharm. Sci. 98 (9),3430-3446 (2009).

11. .R.M. De Beer et al., Talanta 83 (5), 1623-1633 (2011).

12. S.C. Schneid et al., AAPS PharmSciTech. 12 (1), 379-387 (2011).

13. .C. Schneid et al., J. Pharm. Sci. 98 (9), 3406-3418 (2009).

14. J.C. Kasper et al., Eur. J. Pharm. Biopharm. online, DOI 10.1016/j.ejpb.2012.10.009, 15 Nov. 2012.

15. S. Bosca, A.A. Barresi and D. Fissore, Pharm. Dev. Technol., online, DOI 10.3109/10837450.2012.757786, Jan. 22, 2013.


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