Advances in PAT for Parenteral Drug Manufacturing - Applying QbD and PAT facilitates process understanding in lyophilization. - BioPharm International

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Advances in PAT for Parenteral Drug Manufacturing
Applying QbD and PAT facilitates process understanding in lyophilization.


BioPharm International
Volume 26, Issue 3, pp. 18-22

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 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/QuestionsandAnswerson CurrentGoodManufacturing PracticescGMPforDrugs/ucm072006.htm, accessed Feb. 13, 2013.

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

5. F. Jameel and W.J. Kessler, "Realtime 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. M. 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. S.C. Schneid and H. Giessler, AAPS PhamSciTech. 9 (3), 729-739 (2008).

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

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

14. J.C. Kasper et a l., 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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