Avance Biosciences developed and compared NGS and ddPCR-based potency assay platforms for a client’s LNP gene-editing drug product, screening candidate cell lines and dose ranges to establish a reproducible, cross-validated readout method.
Avance Biosciences developed a cell-based NGS assay to characterize on- and off-target gene-editing activity for a client’s LNP drug product, comparing editing at both loci across single-dose and repeated low-dose exposure to support its nonclinical characterization program.
This case study details how Avance Biosciences validated a multi-color flow cytometry identity assay for cGMP cell therapy drug substance release, confirming specificity and precision across five surface markers. The method met predefined acceptance criteria across three analysts and multiple days under a pre-approved validation protocol.
This case study details how Avance Biosciences qualified an LC-MS/MS potency assay for a lentiviral gene therapy vector, measuring percent metabolite reduction in transduced patient-derived cells. The method met precision, assay performance, and system suitability criteria across two analysts and two days under a pre-approved cGMP protocol...
This case study explores a dual-platform potency assay strategy for multivalent LNP-mRNA vaccines, combining ELISA and flow cytometry to assess both mRNA expression and delivery performance. It highlights key analytical challenges and provides practical insights to support robust, scalable, and regulatory-ready potency testing.
Download our technote, Clarifying Suitability Testing: A Common Source of Misunderstanding in Regulated Assay Work, to better understand the distinct roles of method suitability, matrix effect evaluation, and system suitability testing (SST) in regulated analytical workflows. This resource explains how these tests differ, where they overlap, and how they should be applied to meet FDA, EMA, and ICH requirements...
Download our technote, Successful Development of Cell-based Potency Assays, to explore the essential role of potency assays in evaluating the biological activity of complex therapeutics, including cell and gene therapy products. This comprehensive guide draws on our extensive experience designing and validating custom potency assays, offering practical insights into assay formats, MOA selection, and relative potency determination...
Dive into the comparison of quantitative PCR (qPCR) and digital droplet PCR (ddPCR), uncovering their strengths, limitations, and optimal applications. Backed by decades of experience, Avance Biosciences offers unparalleled expertise in both qPCR and ddPCR technologies, ensuring accurate results and compliance within regulatory environments. Discover the nuances between these methodologies and learn how to choose the right approach for your bioanalytical challenges...
This guide provides an in-depth look at GUIDE-Seq/iGuide, a key technique for assessing CRISPR-Cas9 on- and off-target effects in gene and cell therapy development. It explains how the method informs the selection of gRNAs, nucleases, and CRISPR conditions to maximize specificity and safety. Readers will also gain insights into the full workflow, from Cas9 cleavage to NGS analysis, supported by Avance Biosciences’ expertise as a licensed GUIDE-Seq service provider...
Explore the power of Next Generation Sequencing (NGS) for biologics development support with our latest whitepaper. Avance Biosciences is at the forefront of NGS testing, offering tailored solutions to support drug development initiatives and GMP manufacturing activities. Delve into real-world case studies, including CRISPR indel amplicon sequencing and insertion site studies, showcasing our expertise in assay development and validation...
Avance Biosciences is a leading Contract Research Organization (CRO) and Contract Testing Organization (CTO) providing CGMP and GLP-compliant analytical and bioanalytical services to support drug development. From early discovery through clinical development and commercialization, we provide CGMP and GLP-compliant services tailored to your therapeutic modality and regulatory needs.
