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Dr. Corinna Fiorotti
Posted by Dr. Corinna Fiorotti BioAgilytix Insight, Industry Update

In Review: Evaluating the New ICH M10 Guideline Draft

In Review: Evaluating the New ICH M10 Guideline Draft

As a member of Bioanalysis Zone’s recent panel on the new ICH M10 guideline draft, I had the opportunity to have a great discussion with my industry colleagues on the guidance’s recommendations for bioanalytical method validation, aimed at improving the quality and consistency of bioanalytical data supporting biological drug development. These types of conversations are important to have to understand the regulatory thinking behind new changes from the current guidance and to grow consensus around the interpretation of the new guideline’s recommendations. While this draft is not final and still undergoing edits and input, below are some of my initial impressions:

The 2019 ICH M10 Guideline Draft is Direct & Prescriptive
Overall, I find the new ICH M10 guideline on bioanalytical method validation to be very well written. The authors and contributors are very direct and clearly specify the exact validation criteria expected for bioanalytical assays submitted to support regulatory submissions—down to the numbers of runs, replicates, and days needed to perform them. When my fellow panel members asked if I thought there was any risk of a misinterpretation of the guideline, I could only say no. Perhaps there are some extenuating cases in which there could be a minor misinterpretation, but for the most part, I don’t anticipate much disparity in interpretation among the bioanalytical community.

Will the ICH M10 Guideline Draft Influence SOPs?
In terms of how the new guideline will influence bioanalytical sponsors and Standard Operating Procedures (SOPs), it’s likely that sponsors are already starting to look at the draft in order to prepare for the final guidance. Important questions sponsors are starting to ask themselves likely include: How do our SOPs align with the draft now? Where are the disparities, and what do we need to do to get them up to the appropriate level and bring them in line with any new recommendations? But, it is important to keep in mind that this is just a draft—we will only see its full impact on sponsors when the final guidance is released.

Standard Report Templates Still Are Not Efficient, Feasible, or Practical
Some bioanalytical sponsors are very specific in what they want to see in their report, and so it’s important to collaborate with sponsors when determining what data and information will be included in their final reports. While a standard report template would make this process easier and faster, they still are not efficient, feasible or practical, which is why the ICH M10 guideline draft doesn’t include one. I think it would be particularly difficult to harmonize a standard template among all of the newer modalities that we are now seeing in the field, such as CAR-T therapies, gene therapies, tri-specific antibodies, bicyclic peptides (bicycles), scaffolds, etc. I do not believe a standard template could obtain all of the data that would be necessary for all of the different assets that are now coming through the industry. Standardizing a report template is a great idea, but I think it would be substantially difficult to make one.

Gain more insight by watching the full-length Business of Bioanalysis panel discussion on the new ICH M10 guideline on bioanalytical method validation from the scientists at BioAgilytix. I’d also be happy to continue to conversation with you personally if you have thoughts or questions on this topic or other large molecule needs. Feel free to reach out to me directly at

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