Solve stability problems in preformulation and process development using DSC

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00:00:00 Solving stability problems in preformulations and process development using DSC
00:01:24 Solving stability problems in preformulations and process development using DSC
00:01:57 MicroCal DSC systems
00:02:22 Why Microcalorimetry?
00:03:26 DSC experimental principleProtein unfolding followed through heat changes
00:07:24 Compare native, altered and mutant formsMicroCal DSC the universal stability monitor
00:09:00 With differential scanning calorimetry you can…
00:09:39 DSC applications in biotherapeutic development
00:09:47 MicroCal VP-Capillary DSC in preformulation development
00:10:22 The use of DSC to aid in the selection of antibody mutants Courtesy Biogen Idec
00:10:32 Most stable antibody constructs identified
00:11:46 The use of DSC for stability screening during pre-formulation developmentCourtesy Diosynth BiotechnologyKatherine Bowers
00:11:58 Pre-formulation decisions using Tm and T1/2
00:13:56 Pre-formulation decisions using Tm and T1/2
00:14:34 The use of DSC to predict long term stabilityCourtesy J. Wen
00:14:51 Correlation of DSC and SEC data for pH screening
00:16:32 How does DSC compare?
00:17:32 MicroCal VP-Capillary DSC system in process development
00:18:42 DSC identifies the most stable elution condition from Protein A columnCourtesy of P. Acharya
00:18:45 The problem
00:20:08 The solution: Identify stabilizing elution conditions using DSC
00:21:27 Benefits of increasing antibody eluate stability
00:22:39 DSC identifies conditions for increased stability after viral inactivation stepCourtesy of Genzyme
00:23:04 Guiding antibody production
00:24:49 Assessment of biocomparability at different manufacturing sitesCourtesy Amgen
00:24:56 Easily assess biocomparability with DSC
00:25:51 MicroCal DSC systems in biotherapeutic development Summary
00:27:23 MicroCal VP-Capillary DSC
00:28:05 MicroCal VP-Capillary DSC software 2.0
00:29:25 Thank You!
00:30:02 Contact Information

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.