Avance Biosciences is pleased to announce the release of our latest technote: Clarifying Suitability Testing: A Common Source of Misunderstanding in Regulated Assay Work. This resource addresses a frequent challenge faced by clients during assay validation—the proper application and timing of suitability testing. Misunderstandings around method suitability, matrix effect evaluation, and system suitability testing (SST) can lead to redundant testing, non-compliant SOPs, and misinterpretation of regulatory guidance.
The technote provides a structured overview of each type of suitability testing, explaining how they are defined in regulatory contexts and how they should be applied in practice. Through clear examples, it distinguishes between method suitability, matrix effect evaluation, and SST, showing where these approaches overlap and where they remain distinct. The guidance helps prevent unnecessary testing, strengthens SOP design, and ensures compliance with FDA, EMA, and ICH M10 requirements.
Whether you are working with ELISA, qPCR, MSD, or cell-based assays, this technote demonstrates practical strategies for incorporating positive controls, evaluating matrix effects, and maintaining system suitability. It is an essential resource for sponsors, laboratory scientists, and quality teams aiming to align assay workflows with regulatory expectations efficiently.
Download the technote today and gain clarity on best practices for suitability testing in regulated analytical and bioanalytical assays.
Access the technote: Avance Biosciences Technotes
For questions, contact us at sales@avancebio.com or call (832) 968-8698.
When you partner with Avance Biosciences™, you gain a CRO partner that is creative, collaborative and dedicated to sound science with a focus on the regulatory requirements our partners require. Contact our technical staff to discuss how we can support you in your project!
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