날짜 기록: August 04 2015

Duration: 57 minutes 39 seconds

Understanding the relationship between formulation stability and protein aggregation is a critical during bio therapeutic development. As a consequence, a number of new technologies, are now available which offer detailed insights into protein behaviour, allowing the evaluation of product stability and process impact. This course will discuss current understanding of Aggregation Pathways, Adverse Immunogenicity and Innovative Techniques to Assess the Quality and Stability of Biopharmaceutical Formulations.

Table of contents
1. New technologies to improve the understanding of bioformulation stability
02:33
2. Aggregation of Therapeutic Proteins: Cause, Control, Adverse Immunogenicity and Roles of Nanoparticles
00:31
3. Acknowledgments
00:07
4. Outline
00:29
5. Causes of Protein Aggregation
00:43
6. Control of Aggregation in Solution: Maximize Conformational and Colloidal Stability
01:38
7. Effects of Conformational and Colloidal Stability on GCSF Aggregation
02:12
8. Particles going along for the ride
00:53
9. New Insights Into Causes of Aggregation from Quantifying Sub-visible Particles
00:19
10. Role of Nano- and Microparticles on IVIG Particle Formation during Agitation
00:17
11. Microparticle Concentrations after Initial Agitation and Subsequent Centrifugations
00:19
12. Nanoparticle Concentrations after Initial Agitation and Subsequent Centrifugation
00:15
13. Microparticles during agitation
00:49
14. Nanoparticle Concentrations during Agitation
00:31
15. Subvisible Particles are Critical Species on the Protein Aggregation Pathway
00:25
16. Why do subvisible protein particles so often look like the ones of the left?
00:37
17. Causes of Protein Particles: Interfaces
00:39
18. Gelation of a mAb at silicone oil-water interface
00:42
19. Experimental setup for gel rupture at the silicone oil-water interface
00:15
20. Gel rupture leads to loss of soluble protein
00:28
21. Presence of surfactants resulted in reduced aggregation
00:12
22. Presence of surfactants led to a decrease in the protein particle mass detected by RMM
00:39
23. Adverse Immunogenicity: When Miracle Drugs Fail
01:08
24. Immunogenicity: Particles as Adjuvants
00:16
25. Effects of route of administration on immunogenicity of rmGH
00:21
26. Particles in rmGH Samples: Only nanoparticles in ultracentrifuged sample
00:45
27. Ultracentrifuged rmGH (week 6): Nanoparticles cause Immunogenicity
00:32
28. Mishandling of Products by Pharmacies, Clinics and Patients
00:19
29. Stresses to Protein Therapeutics even during “Proper” Handling for IV Infusion
00:35
30. Mimicking the infusion setup…
00:15
31. IVIg in Saline – particle counts > 1µm
00:31
32. IVIg in Saline – total nanoparticle counts
00:15
33. IVIg-0.22um- filter FlowCam Images; Large particles downstream from filter
00:18
34. Removing tube downstream from filters reduces large subvisible particles formed
00:40
35. Polycarbonate Particles in IV Saline: G3 ID Raman Microspectroscopy
00:44
36. Conclusions
00:42
37. Advanced Technologies to Improve the Understanding of BioFormulation Stability
01:00
38. Content
00:16
39. Stability of Biotherapeutics
00:01
40. Industry Drivers
00:30
41. Stability Screening – Thermal Stability
01:12
42. Stability Screening – Thermal Stability
00:33
43. Understanding Protein Stability
00:51
44. Helix- Providing Further Understanding
00:24
45. Helix- Providing Further Understanding
00:24
46. Helix- Providing Further Understanding
00:46
47. Helix- Providing Further Understanding
01:26
48. Comparison of mAb with mmAb: Thermal Stability
01:41
49. Comparison of mAb with mmAb: Kinetics
01:20
50. Sub-visible Particles
00:21
51. Immunogenicity
00:32
52. NanoSight Technology
00:53
53. NanoSight – High Resolution SVP Characterisation
00:32
54. Characterizing Sub-visible Particles
01:09
55. Characterizing Sub-visible Particles
00:56
56. Archimedes: Distinguishing Protein and Silicone
00:57
57. Particle Identification
00:13
58. Particles in Protein Formulations
00:28
59. Characterizing/Identifying Contaminants
00:23
60. Characterizing/Identifying Contaminants
00:39
61. Characterizing/Identifying Contaminants
00:17
62. Characterizing/Identifying Contaminants
00:29
63. Sub-visible Particles
00:18
64. Sub-visible Particles
00:25
65. Closing Remarks
00:50
66. Thank you for your attentionAny questions?
00:21
67. Effects of Conformational and Colloidal Stability on GCSF Aggregation
00:31
68. Particles going along for the ride
00:54
69. Thank you for your attentionAny questions?
12:31
70. Contact Information
00:42