Month: July 2026
Five Recurring Deficiencies in Biologic Assay Submissions
Every biologic program passes through regulatory review, and the bioanalytical package is among the most scrutinized components of any submission. Agencies including the FDA and EMA consistently issue questions, information requests, and deficiency letters tied to assay validation, immunogenicity characterization, and data integrity. What follows is not a catalog of individual enforcement actions but a…
Validating Bioanalytical Assays Under ICH M10
A Practical Walkthrough for Biologics Sponsors For years, sponsors developing biologic therapeutics navigated a patchwork of regional expectations for bioanalytical method validation. A study designed to satisfy FDA bioanalytical method validation (BMV) guidance did not always map cleanly onto EMA expectations, and submissions intended for multiple regions often required duplicated or reconciled validation work. The…