Live biotherapeutic products are characterized by their diversity, which present 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. Read more >
BA Sciences is a cGMP-compliant, FDA/DEA registered, ISO/IEC-17025:2017 accredited analytical laboratory with locations in Salem, NH and Morrisville, NC, providing testing services to Pharmaceutical, Biopharmaceutical & Medical Device companies worldwide. Our focus is to provide undeniably accurate data ensuring patient/consumer safety through critical sampling, staffing, and testing services.
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