We help industry adopt rapid sterility testing methods by guiding the validation and regulatory integration of advanced technologies—including next-generation sequencing (NGS) and other molecular methods—into biomanufacturing workflows. Our expertise ensures these tools are effectively implemented to enhance quality assurance, accelerate time to release, and meet the evolving demands of modern biomanufacturing.
We provide expert support in developing Chemistry, Manufacturing, and Controls (CMC) strategies for Live Biotherapeutic Products (LBPs), a particularly challenging area due to the novelty and complexity of these products. Our deep microbiological expertise and understanding of evolving regulatory expectations help ensure product quality, consistency, and compliance from development through commercialization.
We support probiotic manufacturers in establishing robust quality control strategies that ensure strain identity, viability, and purity throughout the production process. By leveraging advanced molecular methods and industry standards, we help clients navigate the unique challenges of live microbial products to deliver safe, consistent, and effective probiotics.
We assist developers of NGS-based infectious disease diagnostics in designing, validating, and implementing assays that meet both scientific and regulatory standards. Our expertise ensures accurate pathogen detection, robust bioinformatic pipelines, and smooth regulatory navigation in this rapidly evolving field.
We help companies develop and refine direct-to-consumer microbiome testing services by ensuring scientific rigor, regulatory compliance, and clear consumer communication. From assay design to data interpretation and reporting, we bring deep expertise in microbiome science and standards development to support credible, impactful consumer products.
We offer specialized support in the development of customized microbial reference materials to ensure accuracy, consistency, and comparability across analytical workflows. By tailoring standards to your specific application—whether for diagnostics, quality control, or regulatory submissions—we help strengthen confidence in your data and accelerate method validation.
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