Live biotherapeutic products (LBPs) are gaining momentum in the drug development space, emphasising the need to establish comprehensive and structured plans for their development. Growth in LBP production can be attributed to well-defined regulatory pathways in regions such as the US and EU, advancements in oral therapies, increased understanding of disease areas associated with the microbiome, and investment efforts to improve scalability of their manufacture.
This whitepaper highlights key considerations for the manufacturing and quality of LBPs, as well as the unique nonclinical evaluations required to permit their use in humans. Chemical, manufacture and control (CMC) requirements for LBPs require strict adherence to regulatory guidelines to ensure quality and safety, with the main challenges stemming from manufacturing including process upscaling, batch-to-batch variability, and differences in the growth yields and strain characteristics. Moreover, unlike conventional medicines, the nonclinical evaluation of an LBP can be complex and requires a case-by-case approach, encompassing efficacy, safety and translocation assessment.
As investment continues to grow in microbiome-based therapeutics, understanding the nuanced development path of LBPs is crucial. This whitepaper serves as an essential guide to mitigating risks and accelerating timelines, particularly for companies targeting global markets.