The development of microbiome-based therapies has taken a significant step forward with Creative Biolabs' launch of an advanced microbial service platform. This initiative aims to standardize the analytical frameworks essential for the safety, efficacy, and consistency of live biotherapeutic products (LBPs), a critical need in the burgeoning field of microbiome-based drug development.
According to an expert from Creative Biolabs, the lack of a structured analytical strategy has led to repetitive studies, causing delays and increased costs before clinical testing. The company's new platform integrates comprehensive strain identification, contaminant analysis, and stability evaluation, among other services, to mitigate these challenges. Techniques such as 16S rRNA sequencing and whole genome sequencing are employed for strain validation, ensuring a robust foundation for downstream efficacy research.
Contaminant detection and purity assessment are also prioritized, given the vulnerability of live microbial formulations to contamination. The platform utilizes advanced methods like qPCR and digital PCR for continuous batch-to-batch purity verification. Furthermore, formulation science and stability studies are supported through cryoprotectant screening and enteric coat evaluation, crucial for the development of biosimilar products.
Creative Biolabs has further enriched its offerings with a portfolio of probiotic reference materials, including DNA standards and engineered expression strains, to enhance methodological validation and testing reproducibility. This comprehensive approach not only addresses current bottlenecks in LBP development but also paves the way for more predictable and controlled advancements in this emerging therapeutic class.
