CMC Support Archives

20 10, 2025

Technote: Successful Development of Cell-based Potency Assays

webmaster2025-12-23T18:16:02+00:00

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...

Technote: Successful Development of Cell-based Potency Assayswebmaster2025-12-23T18:16:02+00:00

20 10, 2025

Technote: GUIDE-Seq/iGuide for CRISPR On/Off Target Analysis

webmaster2025-12-23T18:18:47+00:00

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...

Technote: GUIDE-Seq/iGuide for CRISPR On/Off Target Analysiswebmaster2025-12-23T18:18:47+00:00

20 10, 2025

Technote: NGS for Biologics Development Support

webmaster2025-12-23T18:19:02+00:00

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...

Technote: NGS for Biologics Development Supportwebmaster2025-12-23T18:19:02+00:00

17 10, 2025

Poster Presentation: Genome-wide Mapping of CRISPR-Cas Off-Target Cleavage Sites via GUIDE-Seq
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Poster Presentation: Genome-wide Mapping of CRISPR-Cas Off-Target Cleavage Sites via GUIDE-Seq

webmaster2025-12-23T18:19:46+00:00

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...

Poster Presentation: Genome-wide Mapping of CRISPR-Cas Off-Target Cleavage Sites via GUIDE-Seqwebmaster2025-12-23T18:19:46+00:00

5 08, 2025

Case Study: Ensuring Plasmid Sequence Fidelity and Purity by NGS for IND-Enabling Drug Substance Release
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Case Study: Ensuring Plasmid Sequence Fidelity and Purity by NGS for IND-Enabling Drug Substance Release

webmaster2025-12-24T14:47:55+00:00

When a gene therapy company needed to verify plasmid identity, purity, and integrity for an IND submission, Avance Biosciences delivered a validated NGS-based solution. The assay enabled low-level variant detection and trace contaminant analysis, supporting FDA compliance and lot release.

Case Study: Ensuring Plasmid Sequence Fidelity and Purity by NGS for IND-Enabling Drug Substance Releasewebmaster2025-12-24T14:47:55+00:00

Avance Biosciences to Exhibit at the World Vaccine Congress 2026

Avance Biosciences to Exhibit at Festival of Biologics USA 2026

FDA Increases Flexibility on CMC Requirements for Cell and Gene Therapies to Advance Innovation

How Consistent Assay Performance Reduces Batch Failures

What PERT Signals About the Future of Gene Editing Manufacturing and Regulation

What “Fit-for-Purpose” Really Means in Bioanalytical Method Development