날짜 기록: November 29 2016

Duration: 42 minutes 03 seconds

In recent years, the delivery of biological drugs via prefilled syringe-style devices has rapidly become more prevalent, in direct response to consumer demand. However, there are some challenges associated with this delivery method. One such challenge is understanding and characterizing the formation of particulates in the subvisible and submicron range within the final drug product.

These particulates can result from manufacturing and fill issues, exposure of the product to temperature or mechanical stress, or reaction of the drug to excipients and contaminants, as a few examples. Since silicone oil is widely-used as a lubricant for syringe plungers and for coating the barrels of syringes, it is commonly found in droplet form as a contaminant in injectable formulations.

In some cases, it is thought that silicone oil droplets may act as a nucleus to promote the formation of protein aggregates in drug products, potentially increasing unwanted immunogenicity.

This presentation provides a comprehensive review of current and recently-developed technologies which can be used for the assessment of particular content in therapeutic formulations.
Table of contents
1. Welcome
00:11
2. A comprehensive guide for technologies to assess particle content in injectable drugs
00:04
3. Introduction
00:48
4. Abstract
00:48
5. What do you mean by ‘particles’?
01:10
6. What do you mean by ‘particles’?
00:24
7. What do you mean particles?
00:30
8. What do I need to measure?
02:29
9. What has the FDA said?
01:14
10. So what can I use to measure my particles?
01:54
11. So what can I use to measure my particles?
00:26
12. Light Obscuration
01:17
13. Flow Image Analysis
01:26
14. Malvern Technologies for Subvisible Particles
01:05
15. Malvern technologies for subvisible particles
02:00
16. Malvern technologies for subvisible particles
01:36
17. Archimedes – an exclusive technology to count and separate subvisible particles based on their density
01:21
18. Archimedes application example
00:48
19. Archimedes - Distinguishing protein from silicone oil
01:56
20. Identification of Subvisible Particles
01:27
21. Morphologi G3SE-ID
01:50
22. Identification of Subvisible Particles in Suspended Bioformulations
02:04
23. Identification of Subvisible Particles in Suspended Bioformulations
00:05
24. Application example
01:04
25. Counting & identification of particles captured on filter membranes
02:42
26. Identification of Particles Whislt in Solution
01:54
27. Submicron Particle Charaterization
01:25
28. NanoSight – submicron particle characterization
00:05
29. Protein aggregation
01:11
30. Concentration – protein aggregation
00:57
31. Heat-induced protein aggregation:
00:52
32. Why should I use all of these techniques?
00:56
33. Why should I use all these techniques?
00:39
34. Why should I use all these techniques?
01:01
35. Thank you for your attentionAny questions?
02:05
36. Contact Information
00:19