Fecha registrada: March 14 2017

Duration: 47 minutes 14 seconds

Differential scanning calorimetry (DSC) is a robust and powerful physical method for characterizing the thermal stability of proteins. During the life history of a commercial therapeutic protein product, DSC analysis is uniquely valuable from early discovery research to commercial product management. Areas in which DSC is used include: comparing stability of potential drug candidates; conducting preformulation and formulation screening studies; biophysical characterization of drug product for regulatory filings; comparability studies after a manufacturing change; and comparing a biosimilar to an innovator drug product. DSC analysis of a protein also can provide insightful data in investigations of the roles of specific domains in the instability and aggregation of multidomain proteins.

In this webinar, some examples of these applications will be described. In addition, results from studies on the effects of heating rate will presented, which demonstrate that faster heating results in both increased sample throughput and increased method sensitivity. Finally, data will be presented from a recent biophysical comparison of antibody drug conjugates to the parent antibody. These results documented that important differences in thermal stability could readily be resolved and quantified with DSC; whereas during heating studies with various spectroscopic techniques no differences were discernable.
Table of contents
1. Welcome
00:14
2. Introduction
01:37
3. Differential scanning calorimetry: Robust and powerful physical characterization of therapeutic protein products
00:38
4. Outline
00:56
5. Applications of DSC in the Development of Therapeutic Protein Products
01:19
6. Untitled
01:38
7. DSC Measures Effects of Both Conformational and Colloidal Stabilities
01:59
8. Applications of DSC in the Development of Therapeutic Protein Products
00:12
9. Untitled
01:32
10. Untitled
01:32
11. Applications of DSC in the Development of Therapeutic Protein Products
00:18
12. Untitled
01:20
13. Untitled
01:24
14. Applications of DSC in the Development of Therapeutic Protein Products
00:12
15. Untitled
01:00
16. Applications of DSC in the Development of Therapeutic Protein Products
00:04
17. Untitled
01:03
18. Applications of DSC in the Development of Therapeutic Protein Products
00:07
19. Untitled
02:13
20. Applications of DSC in the Development of Therapeutic Protein Products
00:09
21. Untitled
03:48
22. Neupogen and Zarxio dialyzed into Neupogen formulation
00:11
23. Untitled
00:18
24. Neupogen and Zarxio dialyzed into Neupogen formulation
00:16
25. Applications of DSC in the Development of Therapeutic Protein Products
00:15
26. Antibody-Drug Conjugates: A New Class Of Therapeutic Agents
00:45
27. Types of Reactions for Synthesizing Trastuzumab-ADC’s (T-DM1)
01:06
28. Thermal Stability using Differential Scanning Calorimetry
01:25
29. Data are examples of the highly reproducible results with DSC
01:42
30. Heating with fluorescence spectroscopy
00:50
31. Heating with Far-UV CD spectroscopy
00:31
32. Increasing DSC sample throughput with relatively fast heating rates
01:33
33. Effect of pH on Avastin Stability
01:30
34. Effect of pH on Avastin Stability Observed at all Scan Rates
01:01
35. Differential Scanning Calorimetry: Scan Rate Dependence on apparent Tm of Herceptin®, Kadcyla® and Syn-ADC
00:17
36. Untitled
00:50
37. Plot of 1 𝑇 𝑚 vs ln 𝑣 𝑇 𝑚 2 and Energies of Activation
00:53
38. High Throughput Analysis with Automated DSC
02:12
39. High Throughput Analysis with Automated DSC
00:30
40. 2017 Colorado Protein Stability Conference
01:51
41. Thank you for your attentionAny questions?
05:17
42. Contact Information
00:46