Fecha registrada: October 18 2018

Duration: 32 minutes 50 seconds

Significant advances have been made in analytical technology for the characterization and identification of particles present in pharmaceutical products.  With these advances comes a tremendous amount of new data with which to characterize biologics, devices, and small molecules.  In parallel with these technological advances, the regulatory agencies have shown increased interest in more in-depth characterization of therapeutic products.  Careful interpretation of data and deeper understanding of the method limitations is of utmost importance when using complementary methods to characterize particle profiles of therapeutic products for regulatory submissions. This presentation demonstrates how multiple particle techniques can be used to adequately characterize therapeutic products and their particle populations.
Table of contents
1. Untitled
00:19
2. Untitled
01:40
3. Untitled
00:16
4. Developing safe, effective and consistent drug products requires controls around critical quality attributes
01:11
5. Particle Characterization
01:28
6. Light Obscuration
00:05
7. Increased Expectations for Particle Characterization
01:29
8. Particle Techniques = High Resolution Detection of Degradants
03:20
9. Particle Techniques = High Resolution Detection of Degradants
01:06
10. Untitled
00:47
11. Light Obscuration vs MFI
00:36
12. Light Obscuration vs MFI
00:52
13. Untitled
00:47
14. Untitled
01:11
15. Untitled
00:05
16. Untitled
00:43
17. Early Evaluation of Particles with Simulated Administration Studies is HIGHLY Recommended!!
01:26
18. Untitled
00:33
19. Untitled
00:22
20. Untitled
02:06
21. Untitled
00:36
22. Untitled
00:43
23. Untitled
01:06
24. Untitled
01:09
25. Untitled
00:05
26. Untitled
01:13
27. Summary
05:29
28. KBI Particle Characterization Core Facility
00:45
29. Thank you for your attentioncraig.sagar@malvernpanalytical.comparticles@kbibiopharma.com
01:22