| 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.