Date recorded: July 30 2015

Duration: 41 minutes 34 seconds

Product quality and safety concerns have driven the enumeration of particulate species in injectable products. Guidelines, such as USP<787>, <788>, and <790>, describe methods for collecting accurate particle count and size data in the sub-visible and visible ranges, and call for the use of microscopic techniques, among others. However, absolute identification of particulates is not currently required, even though such information can be inherently critical to root cause analysis. Hybrid automated microscopic-spectroscopic systems are capable of providing both particulate enumeration and identification well into the sub-visible range, extending the potential of routine counting to include explicit chemistry. This webinar will discuss improvements in sample presentation for both suspended and filtered samples, and provide application examples of biotherapeutic relevance using these new methods.

Table of contents
1. Welcome
01:22
2. Improved approaches for particulate characterization in biotherapeutics
00:57
3. Particulate Characterization – What particulates?
02:29
4. Protein Aggregates – General
01:41
5. Protein Aggregates – General Characteristics
01:41
6. Protein Aggregates (& Foreign Matter) – Importance
01:02
7. Protein Aggregates – What techniques are in use?
02:33
8. Morphologi G3SE-ID
01:26
9. Morphologi G3-ID- Identification of Sub-visible Particles in Suspended Bioformulations
01:11
10. Novel approach – thin path wet cell
00:06
11. Thin-Path Wet Cell* – Details
02:13
12. Test Sample – IVIg Suspension
01:37
13. Particle Count Results – IVIg Suspension
00:41
14. Particle Count Results – IVIg Suspension
00:21
15. Particle Identification Results – IVIg Suspension
03:08
16. Particle Identification Results – IVIg Suspension
01:00
17. Novel approach – Glass membrane filter
00:10
18. Glass Membrane Filter* – Details
02:07
19. Test Sample – IV Bolus with IVIg Suspension
01:17
20. Particle Count Results – IV and IVIg on Filter
01:09
21. Particle Identification Results – Filtered IV and IVIg
00:53
22. Particle Identification Results – Filtered IV and IVIg
01:40
23. Particle Identification Results – Filtered IV and IVIg
01:04
24. Wet Cell and Filter – Comparison Summary
01:44
25. Conclusions
01:21
26. Thank you for your attention
05:43
27. Contact Information
00:58