Multi-laboratory comparisons of manual patch clamp hERG data generated using standardized protocols and following ICH S7B Q&A 2.1 best practices

HESI Global, in partnership with the U.S. Food and Drug Administration (FDA) through the FDA’s Broad Agency Announcement (BAA) program, has published a new peer-reviewed study evaluating manual patch clamp hERG data generated using harmonized protocols and regulatory best practices.

The manuscript, titled “Multi-laboratory comparisons of manual patch clamp hERG data generated using standardized protocols and following ICH S7B Q&A 2.1 best practices” by Alvarez Baron et al., is now available open access in Nature Scientific Reports (2025).

🔗 Read the full article

The hERG potassium channel is a critical tool in cardiac safety assessments, as inhibition of this channel is associated with the potential for drug-induced arrhythmias. This study presents results from a multi-site comparison of manual patch clamp data and evaluates the application of ICH S7B Q&A 2.1 recommendations. The findings offer important insights into the reproducibility, performance, and variability of this assay across laboratories and platforms.

Importantly, all hERG data used in this publication are publicly available via the Open Science Framework:

📂 https://osf.io/a6k5t/

This effort aligns with HESI Global’s mission to collaboratively generate science that informs safer, more effective public health decisions. It also supports broader regulatory confidence in in vitro cardiac safety assessments by improving transparency and access to standardized datasets.

Learn more about the HESI Global Cardiac Safety Committee here.