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Dr. Dominique Gouty
Posted by Dr. Dominique Gouty BioAgilytix Insight, Industry Update

Key Takeaways from the 11th Workshop on Recent Issues in Bioanalysis

Key Takeaways from the 11th Workshop on Recent Issues in Bioanalysis

Scientists from BioAgilytix, myself included, recently attended the 11th WRIB in Los Angeles, CA. I thoroughly enjoyed meeting so many new contacts and taking part in presentations and discussions concerning the most innovative topics in bioanalysis, biomarkers, and immunogenicity. Throughout the workshop it became very clear to me that gatherings like WRIB are vital in staying on the same page about bioanalytical best practices. I was able to learn from my peers and update myself on the latest regulatory guidance, evolving and new methods for large molecule studies, and much more. The following are a few of the topics that our team found to be most interesting at WRIB this year:

Anti-drug Antibodies Validation: Guiding a Way Forward
Many of the biopharmaceutical candidates that we work with on a daily basis have the potential to induce anti-drug antibodies (ADA). Because ADAs can impact patient safety and drug efficacy in a major way, sensitive ADA detection is vital in any drug development program. ADA validation was a topic covered thoroughly at the 11th WRIB Conference. A new takeaway for us was the increasing expectation for ADA validation to contribute to selectivity for the confirmatory steps of assay development. Discussions also highlighted conflicting guidance on ADA assay sensitivity and the clinical relevance of ADA data, with the suggestion that assays may need to focus on more clinically relevant ADA (e.g., persistent ADA).

Ligand Binding Assay Validation: To Mass Spec Or Not?
Our team took part in quite a few conversations relating to the validation of Ligand Binding Assays (LBA). Overall consensus seemed to be that, while hybrid LBA/LCMS affords some interesting possibilities, regulators have yet to review a project like this with scrutiny. So while regulators seemed open to the idea if it could be executed in an effective way, it was noted that there would be significant regulatory risk in relying solely on such an approach at this time.

In another discussion about the correction of dilution variability by use of an internal standard in ELISA methods, there was a general agreement that this would be very helpful in a GMP setting, both for potency testing and for troubleshooting. However, the consensus reached was this method is likely to unfortunately add too much complexity to the process to justify its use in routine LBA bioanalysis.

Biomarker Validation: Giving Purpose through Context
During WRIB it was presented that the “context of use” should drive “fit for purpose” biomarker validation needed for the intended use, and that the appropriate validation parameters should be largely determined by “fit for purpose” and the drug development stage.

Many of us who were a part of the discussion have found the recommendations from Jean Lee’s paper for biomarker validation to be helpful. This paper speaks to the approach that when validating biomarkers, you need only to validate those parameters which are relevant for that particular stage of drug development, and to answer the scientific question(s) that must be asked at that phase to effectively progress the biomarker on. The validation parameters will become increasingly more stringent as you move beyond the exploratory phases, but the “fit for purpose” approach enables more rapid decision-making on the biomarker’s viability in the early stages of development. If and when the biomarker will be used for things like diagnostics or determining patient dosing level, then using official CLSI documents may be more appropriate.

After the 11th WRIB our team is excited to get back to work and to begin applying what we’ve learned from our peers. Every time I take part in a large gathering of bioanalytical scientists I am inspired to continue to innovate and produce high-quality science for our clients and the patients they serve.

If you have any questions about how BioAgilytix handles issues in bioanalysis please feel free to reach out to me personally!

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