Abstract 

Live biotherapeutic products (LBPs) are a unique group of biologics in which the active substances are live microorganisms. The intended use of the LBP, whether for wellness or disease treatment, dictates the regulatory pathway.

In the absence of specific and harmonised guidelines, sponsors need to rely on early interaction with regulatory authorities to clarify expectations and align on development programmes. The successful advancement of LBPs depends on sponsors being proactive, scientifically rigorous and having a detailed regulatory strategy to de-risk the quality, safety and efficacy challenges faced in LBP development.

This article summarises the current US and EU regulatory landscape for LBPs and provides practical, risk-based considerations across chemistry, manufacturing and controls (CMC), nonclinical and clinical development to help sponsors plan development programmes and align early with regulators.