By Pamela Hamill, Ph.D.; Amy Glekas, Ph.D.; Greg Pirozzi, Ph.D.- BioReliance

Published in: Outsourced Pharma Newsletter 3/4/24, Louis Garguilo, Chief Editor, Outsourced Pharma <info@OutsourcedPharma.comoriginal Millipore Sigma_WP9709EN Ver. 1.0 43886 09/2022

Published on: March 4, 2024

Conducting stability studies is a critical aspect of the drug development process, as the information gained determines key clinical development decisions and becomes an essential component of the submission package required by regulatory authorities globally. For any biological therapy, there is a set of attributes that is critical to maintaining the product’s safety and efficacy; the purpose of stability studies is to analyze these attributes at predetermined timepoints during the study to understand how they may be impacted by storage in different environmental conditions. Through understanding the links between storage and product degradation that may give rise to loss of biological activity, possible toxicity or unwanted immunogenicity that pose potential risk to patient health, stability studies generate the data necessary to specify the storage conditions required to maintain product quality and safety and justify the shelf life and expiration dates for your biological product.

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