| 00:00:00 | Welcome |
| 00:01:22 | Improved approaches for particulate characterization in biotherapeutics |
| 00:02:19 | Particulate Characterization – What particulates? |
| 00:04:48 | Protein Aggregates – General |
| 00:06:29 | Protein Aggregates – General Characteristics |
| 00:08:10 | Protein Aggregates (& Foreign Matter) – Importance |
| 00:09:12 | Protein Aggregates – What techniques are in use? |
| 00:11:45 | Morphologi G3SE-ID |
| 00:13:11 | Morphologi G3-ID- Identification of Sub-visible Particles in Suspended Bioformulations |
| 00:14:22 | Novel approach – thin path wet cell |
| 00:14:28 | Thin-Path Wet Cell* – Details |
| 00:16:41 | Test Sample – IVIg Suspension |
| 00:18:18 | Particle Count Results – IVIg Suspension |
| 00:18:59 | Particle Count Results – IVIg Suspension |
| 00:19:20 | Particle Identification Results – IVIg Suspension |
| 00:22:28 | Particle Identification Results – IVIg Suspension |
| 00:23:28 | Novel approach – Glass membrane filter |
| 00:23:38 | Glass Membrane Filter* – Details |
| 00:25:45 | Test Sample – IV Bolus with IVIg Suspension |
| 00:27:02 | Particle Count Results – IV and IVIg on Filter |
| 00:28:11 | Particle Identification Results – Filtered IV and IVIg |
| 00:29:04 | Particle Identification Results – Filtered IV and IVIg |
| 00:30:44 | Particle Identification Results – Filtered IV and IVIg |
| 00:31:48 | Wet Cell and Filter – Comparison Summary |
| 00:33:32 | Conclusions |
| 00:34:53 | Thank you for your attention |
| 00:40:36 | Contact Information |
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.