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...
Next-generation sequencing (NGS) technologies are transforming regulated drug development by enabling high-resolution analysis for applications such as gene editing, adventitious agent detection, and sequence confirmation. However, integrating NGS into GMP and GLP workflows introduces significant challenges related to data integrity and compliance with 21 CFR Part 11. These regulations require strict controls over electronic records...
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...
Download our whitepaper on “Phage Testing of Bacterial Cultures” to understand the critical importance of mitigating phage contamination in biotech and pharmaceutical industries. Learn about the lytic and lysogenic life cycles of phages, their role in bacterial biology, and the challenges they pose to the biotech and pharmaceutical industries due to contamination. Phage presence in cultures can significantly skew results, posing challenges in bacterial identification and isolation...
Next- and third-generation sequencing are vital for GMP, GLP, and clinical applications, but data integrity challenges and 21 CFR Part 11 compliance require secure instruments, validated workflows, and robust audit trails...
Genome editing offers unprecedented precision, but off-target effects remain a key safety concern. GUIDE-Seq provides a high-throughput, genome-wide method to map CRISPR-Cas activity in living cells, enabling researchers to assess specificity and ensure safer gene-editing therapies...
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.
