How stable is stable?

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00:00:00 How stable is stable?
00:00:05 Introduction
00:01:42 Combining Biophysical Techniques and Advanced Kinetics to Support Formulation Development and Stability of Biologics
00:02:01 DSC and NTA
00:02:44 Lab automation architecture
00:04:07 High Throughput Screening
00:05:19 DSC
00:06:28 DSC
00:07:03 DSC
00:07:36 DSC
00:08:40 Kinetic stability of proteins
00:09:25 Kinetic stability of proteins
00:10:07 Kinetic stability of proteins
00:11:15 Kinetic stability of proteins
00:11:58 Kinetic stability of proteins
00:12:40 Kinetic stability of proteins
00:13:42 Untitled
00:14:37 Aggregates and particles in vaccines and biotherapeutics
00:15:45 Virus based vaccine, number of particles in vials
00:16:31 Viral particles as colloids
00:16:51 Nanoparticle Tracking Analysis (NTA)
00:17:20 Nanoparticle Tracking Analysis (NTA) using NS300
00:17:29 Nanoparticle Tracking Analysis (NTA) using NS300
00:18:23 Rabies virus particles characterized by NTA
00:19:07 Rabies virus particles characterized by NTA
00:19:12 Rabies virus particles characterized by NTA
00:20:22 Quantification and size distribution of PVRV-NG potent and subpotent batches obtained by heat treatment
00:21:05 PVRV-NG bulk forced degradation study Protocol
00:21:33 PVRV-NG bulk forced degradation study Kinetic of size distribution profile
00:22:08 PVRV-NG bulk forced degradation studyInverse correlation between antigenicity & size polydispersity
00:22:43 PVRV-NG bulk forced degradation studyStability modeling
00:23:22 PVRV-NG bulk forced degradation studyStability modeling
00:24:21 Stability modeling approach to predict shelf-life of bioproducts
00:25:45 Stability modeling- Major applications
00:25:50 Untitled
00:27:32 Untitled
00:28:25 Questions?
00:28:38 Thank you

Proteins are fragile macromolecules and it is important to use the relevant analytical tools for their formulation development. This webinar will describe how a number of technologies were employed by a team at Sanofi Pasteur to understand and predict the stability of their vaccine formulations. The first technique explored was differential scanning calorimetry (DSC) which is able to determine the thermodynamic and kinetic stability of proteins. The TM value is considered an indicator of protein thermal stability, but it doesn't provide information on the kinetic process. As proteins which are kinetically stable exhibit high free energy barriers, we advantageously used this parameter as an indicator of protein long-term stability. Free energy barriers separating the native state from the non-functional forms were obtained using heating rate dependance of DSC profiles.

Nanoparticle tracking analysis (NTA) was then conveniently used for counting and sizing viral particles. During a forced degradation study of vaccines, increase in particle size polydispersity by NTA and loss of antigenicity by ELISA was concomitently observed. Thus, the concordance between NTA and conventional ELISA method was demonstrated. 

Finally, combining advanced kinetics and modern statistical analyses, a general procedure was developed to predict the shelf-life of biologics from forced degradation data. This stability modeling approach was successfully applied for protein stability predictions, expiry date estimations, and to evaluate the impact of temperature excursions (cold chain breaks).


Didier Clenet, Senior Scientist - Formulation and Stability Platform, Bioprocess Research and Development, Sanofi Pasteur. Didier joined the R&D Formulation & Stability platform of Sanofi-Pasteur in 2011. His work is focused on high throughput screening of formulations, the structure-activity relationship of biotherapeutics and vaccines, and stability prediction using advanced kinetics.

Over more than 15 years in Sanofi R&D, Didier has been dedicated to the physical and biophysical characterization of active ingredients, freeze-dried products and monoclonal antibodies (mAbs and ADCs). His research interests are structural characterization and aggregation state determination using a variety of biophysical techniques (light scattering, flow-imaging, DSC and thermokinetics, fluorescence and infra-red spectroscopy). Didier implemented the Biophysical Lab and a lab-automation platform for bioproduct formulations. He also coaches young scientists and teaches courses in several Universities.

Pour en savoir plus

Who should attend?

Formulation scientists, Stability scientists, Vaccine scientists, Lab Managers, R&D Scientists.

What will you learn?

This webinar will provide an understanding of how a variety of orthogonal technologies can be used together to provide a robust characterization of vaccine formulation stability