Current Industry Best Practice on in-use Stability and Compatibility Studies for Biological Products

Evaluating the in-use stability of a biological product including its compatibility with administration components allows to define handling instructions and potential hold times that retain product quality during dose preparation and administration. The intended drug product usage may involve the d...

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Veröffentlicht in:Journal of pharmaceutical sciences 2023-09, Vol.112 (9), p.2332-2346
Hauptverfasser: Blümel, Markus, Liu, Jing, de Jong, Isabella, Weiser, Sarah, Fast, Jonas, Litowski, Jennifer, Shuman, Melissa, Mehta, Shyam B., Amery, Leanne, Tan, David Cheng Thiam, Jia, Feng, Shekhawat, Dushyant, Dagallier, Camille, Emamzadeh, Mina, Medina, Annette, Santos, Camilla, Gasser, Florian, Urban, Christian
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container_end_page 2346
container_issue 9
container_start_page 2332
container_title Journal of pharmaceutical sciences
container_volume 112
creator Blümel, Markus
Liu, Jing
de Jong, Isabella
Weiser, Sarah
Fast, Jonas
Litowski, Jennifer
Shuman, Melissa
Mehta, Shyam B.
Amery, Leanne
Tan, David Cheng Thiam
Jia, Feng
Shekhawat, Dushyant
Dagallier, Camille
Emamzadeh, Mina
Medina, Annette
Santos, Camilla
Gasser, Florian
Urban, Christian
description Evaluating the in-use stability of a biological product including its compatibility with administration components allows to define handling instructions and potential hold times that retain product quality during dose preparation and administration. The intended drug product usage may involve the dilution of drug formulation into admixtures for infusion and exposure to new interfaces of administration components like intravenous (iv) bags, syringes, and tubing. In-use studies assess the potential impact on product quality by simulating drug handling throughout the defined in-use period. Considering the wide range of in-use conditions and administration components available globally, only limited guidance is available from regulators on expected in-use stability data. A working group reviewed and consolidated industry approaches to assess physicochemical stability of traditional protein-based biological products during clinical development and for commercial use. The insights compiled in this review article can be leveraged across the industry and encompass topics such as representative drug product material and administration components, testing conditions, quality attributes evaluated and respective acceptance criteria, applied quality standards, and regulatory requirements. These practices may help companies in the study design, and they may inform discussions with global regulators.
doi_str_mv 10.1016/j.xphs.2023.05.002
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subjects Analytical chemistry
Polymeric drug delivery system(s)
Protein delivery
Regulatory science
title Current Industry Best Practice on in-use Stability and Compatibility Studies for Biological Products
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