Methods for Characterization and Release Testing of Live Biotherapeutic Products

Live biotherapeutic products are characterized by their diversity, which presents challenges for accurate analytical characterization. Comprehensive analysis is necessary to understand microbial composition, functional mechanisms of action, efficacy, and safety. Regulatory considerations and guidelines further add complexity to the characterization and release testing process.

This white paper explores methods for the characterization and release testing of microbiome therapeutics and live biotherapeutic products. It highlights the limitations of traditional methods and discusses the challenges associated with the complexity of these products. The paper presents various alternative approaches including genomic-based methods (metagenomic sequencing, proteomic and metabolomic techniques) and functional assays. Additionally, it discusses the advantages, limitations, and regulatory considerations of these alternative methods.

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