Datum der Aufzeichnung: 26 September 2014

Duration: 44 minutes 08 seconds

Differential scanning calorimetry (DSC) is a technique that is broadly used in the biotherapeutic industry to measure protein stability. It can be used to measure both the intrinsic stability of a protein and the extrinsic stabilization by excipients and other non-active ingredients. The technique can be fully automated allowing for up to 50 runs a day. In this presentation a number of examples of how the technique is applied in pre/formulations, process development and manufacturing of protein drugs is outlined.

Table of contents
1. Solving stability problems in preformulations and process development using DSC
01:24
2. Solving stability problems in preformulations and process development using DSC
00:33
3. MicroCal DSC systems
00:25
4. Why Microcalorimetry?
01:04
5. DSC experimental principleProtein unfolding followed through heat changes
03:58
6. Compare native, altered and mutant formsMicroCal DSC the universal stability monitor
01:36
7. With differential scanning calorimetry you can…
00:39
8. DSC applications in biotherapeutic development
00:08
9. MicroCal VP-Capillary DSC in preformulation development
00:35
10. The use of DSC to aid in the selection of antibody mutants Courtesy Biogen Idec
00:10
11. Most stable antibody constructs identified
01:14
12. The use of DSC for stability screening during pre-formulation developmentCourtesy Diosynth BiotechnologyKatherine Bowers
00:12
13. Pre-formulation decisions using Tm and T1/2
01:58
14. Pre-formulation decisions using Tm and T1/2
00:38
15. The use of DSC to predict long term stabilityCourtesy J. Wen
00:17
16. Correlation of DSC and SEC data for pH screening
01:41
17. How does DSC compare?
01:00
18. MicroCal VP-Capillary DSC system in process development
01:10
19. DSC identifies the most stable elution condition from Protein A columnCourtesy of P. Acharya
00:03
20. The problem
01:23
21. The solution: Identify stabilizing elution conditions using DSC
01:19
22. Benefits of increasing antibody eluate stability
01:12
23. DSC identifies conditions for increased stability after viral inactivation stepCourtesy of Genzyme
00:25
24. Guiding antibody production
01:45
25. Assessment of biocomparability at different manufacturing sitesCourtesy Amgen
00:07
26. Easily assess biocomparability with DSC
00:55
27. MicroCal DSC systems in biotherapeutic development Summary
01:32
28. MicroCal VP-Capillary DSC
00:42
29. MicroCal VP-Capillary DSC software 2.0
01:20
30. Thank You!
00:37
31. Contact Information
14:06