Live Biotherapeutic Products: Unique Quality, Manufacturing, And Nonclinical Considerations For Clinical Trial Entry

Live biotherapeutic products (LBPs) are emerging as a dynamic area of drug development, driven by clearer regulatory frameworks in the US and EU, advances in oral delivery, deeper insights into microbiome-related diseases, and growing investment in scalable manufacturing. Their development, however, demands tailored strategies that address both manufacturing and nonclinical complexities. This whitepaper outlines critical factors influencing LBP quality and production, emphasizing the stringent chemical, manufacturing, and control (CMC) standards needed to meet regulatory expectations.

Key manufacturing hurdles include scaling production, managing batch-to-batch consistency, and accommodating variations in strain characteristics and growth yields. On the nonclinical side, LBPs differ significantly from traditional drugs, requiring customized assessments of safety, efficacy, and microbial translocation on a case-by-case basis. As microbiome-based therapeutics gain momentum, mastering the intricate requirements of LBP development is essential for minimizing risks and expediting progress. This resource offers practical guidance for navigating these challenges, enabling developers to streamline global market entry and optimize product success.