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Advaxia streamlines method optimization from pre-GMP to clinical production.
Our laboratory possesses industry-leading equipment, software and scientists who specialize in method development, qualification and validation across all the following areas:
Our product-oriented approach enables our team to proceed rapidly from the pre-GMP phase to full-scale production of clinical batches for testing and distribution.
Method Development and Optimization
We use product-development protocols to prove that an assay is fit for its purpose.
Advaxia’s team takes a data-driven approach to the development of assay methods, starting with a deep-dive analysis of the overall methodology, along with experimental data from earlier procedures. We then develop an analytical pipeline for testing specific product characteristics against established acceptance criteria, and select analytical instrumentation and methodology tailored to the procedure’s purpose and scope. We are experienced in evaluating parameters such as linearity, limits of detection (LOD) and quantitation limits (LOQ), range, accuracy and precision, ruggedness, and specificity
Our team of experts is fully equipped and trained to perform:
Phase Appropriate Method Qualification
We confirm that analytical procedures are suitable and compliant with ICH guidelines.
In this integral stage of analytical development, our scientists leverage results from method validation data to assess the quality, reliability and consistency of analytical results, confirming that the test is well-suited to its intended use, and complies with the protocols of the International Council for Harmonization (ICH) guidelines Q2 (R1).
We have significant analytical development and QC testing capability for product release: currently over thirty analytical methods.
Additionally, we have capabilities to support full ICH stability programs at different conditions (long term, stressed and in use) in addition to full product release.