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Ann Clin Trials Vaccines Res. 2017 | Volume 1 Issue 2
Global Vaccines & Vaccination Summit & B2B
November 01-02, 2017 | Toronto, Canada
Stability modeling to predict vaccine shelf-life and evaluate impact of temperature excursions from
the “cold chain”
Didier Clenet
Sanofi Pasteur, France
T
he stability of vaccines is of great interest industries and
government institutions. Accelerated stability studies are
designed to determine the rate of vaccine degradation over
time as a result of exposure to temperatures higher than
those recommended for product storage. However, commonly
applied stability predictions based on application of zero- or
first-order kinetics are very often too simplified for description
of the degradation of biological products, which frequently
undergo complex and multistep degradation reactions. We used
an advanced kinetic approach mixing with statistical analysis
to fit the forced degradation ELISA data by computed kinetic
parameters, and finally, to predict valuable the long-term
stability of vaccine containing several variants in a freeze-dried
form. The modeling approach is based on the selection of the
most appropriate kinetic equations which fit the degradation
rate of compounds subjected to elevated temperatures,
accelerating the rate of the reaction. According to 6 months
data obtained at elevated storage temperatures, “two-step”
models were identified to conveniently describe antigenicity of
variants. We have predicted 2 years antigenicity, in agreement
with real long-term stability data. The stability modeling
procedure was also successfully applied for the prediction of
antigenicity during several temperature excursions, thereby
demonstrating the accuracy of the kinetic models. To the best
of our knowledge, this is the first procedure mixing a global
kinetic approach and modern statistical analyses to accurately
determine a vaccine degradation rate able to predict shelf-life
of bio-products stored in refrigerated condition and suffered
temperature excursions from the cold chain.
Speaker Biography
Didier Clenet has joined R&D Formulation and Stability platform of Sanofi-Pasteur
in 2011. He focuses his work on high throughput screening formulations, stability
prediction using advanced kinetics, vaccine activity structure relationship, particulate
matter in vaccines and adjuvants process optimization and physio-chemical
characterization. For more than 15 years in Sanofi R&D, he was dedicated on physical
and biophysical characterization of active ingredients, freeze-dried products and
monoclonal antibodies (mAbs, ADC). He developed novel X-ray diffraction and thermal
analysis tools to study polymorphism and amorphous state in solid materials. 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). He implemented Biophysical
lab and a lab-automation platform for bioproduct formulations. He is coaching to
young scientists and performed courses in several Universities.
e:
didier.clenet@sanofi.com