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Forced degradation studies: an essential tool for the formulation development of vaccines

Authors Hasija M, Li L, Rahman N, Ausar SF

Received 22 December 2012

Accepted for publication 8 February 2013

Published 13 June 2013 Volume 2013:3 Pages 11—33

DOI https://doi.org/10.2147/VDT.S41998

Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 4


Manvi Hasija, Lillian Li, Nausheen Rahman, Salvador F Ausar

BioProcess Research and Development, Sanofi Pasteur, Toronto, ON, Canada

Abstract: Forced degradation studies are typically conducted during the early development phase of vaccine candidates to obtain information on potential degradation pathways, support analytical methods development, and identify potential vaccine stabilizers and optimal conditions for long-term storage. The regulatory guidelines for forced degradation regarding biologics have few to no procedural instructions on how to approach forced degradation studies. In this review, we provide an overview of methods used to study forced degradation in vaccines, mechanisms of degradation, analytical methodology, forced degradation examples conducted for vaccine products, and a summary of stabilizers that are used to influence the results of new vaccine candidates.

Keywords: vaccine, formulation, stability, pathways of degradation, stabilizers

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