All clinical in-use testing of biotherapeutics aims to develop a stable and safe drug product (DP) and is a regulatory requirement under ICH Q1A guidelines for filing a registration application during early- and late-stage/commercial development.
Testing includes stability and compatibility studies of the materials and diluents used during the in-use period of the DP comprising of the preparation, storage, and simulated administration, which may vary depending on the route of administration and the type of molecule(s) evaluated.
This testing helps ensure patient safety by identifying potential risks due to exposure of not-previously assessed contact materials, diluents or holding times at differing temperatures.
The studies must also demonstrate the stability of the DP after reconstitution and /or dilution, as well as within the proposed administration dosage ranges to ensure that patients receive an accurate dose of DP at an appropriate product quality.
Data obtained from clinical in-use testing should show that the administration procedure of a DP is safe, viable and accurate during clinical and commercial use. This information can be used to support a registration application, such as an Investigational New Drug (IND), Investigational Medicinal Product Dossier (IMPD) or market authorisation filing.
In this article, we discuss the more demanding aspects surrounding clinical in-use testing of biotherapeutic DPs for parenteral delivery while reviewing potential strategies to address these issues. We include technical considerations a biopharma company must handle. Additionally, we illustrate how partnering with Lonza may help to address some of the challenges associated with clinical in-use testing workflows.
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