Unique Quality, Manufacturing And Nonclinical Considerations For Clinical Trial Entry

Live biotherapeutic products (LBPs) represent an emerging frontier in therapeutic development, harnessing living microorganisms to prevent, treat, or cure disease. However, their unique nature introduces complex challenges in Chemistry, Manufacturing, and Controls (CMC) that differ markedly from traditional pharmaceuticals and biologics. Unlike chemically synthesized drugs or monoclonal antibodies, LBPs require precise cultivation, formulation, and preservation of living organisms, all while ensuring consistency, potency, and safety.

Regulatory expectations, while still evolving, emphasize strain characterization, manufacturing reproducibility, and rigorous contamination control throughout the product lifecycle. Sponsors developing LBPs must implement robust process development strategies that integrate microbiological expertise with pharmaceutical quality systems. As regulatory agencies such as the FDA and EMA refine their guidance for LBPs, early and proactive CMC planning becomes essential for de-risking development and accelerating timelines. Companies that can successfully navigate these technical and regulatory hurdles will be well-positioned to unlock the therapeutic potential of the human microbiome and pioneer a new class of medicines.