With the BioProcessing Summit 2025 fast approaching, we’re excited to share that Avance Biosciences™ will not only be exhibiting at Booth #516, but also presenting two posters as part of the Next-Generation Analytical Methods program.
If you’re attending the Summit, be sure to stop by to speak with our team and explore how our assay development, validation, and advanced NGS services can support your biologics, cell, and gene therapy programs.
Poster Title:
Genome-wide Mapping of CRISPR-Cas Off-Target Cleavage Sites via GUIDE-Seq
Conference Program:
C4B: Next-Generation Analytical Methods – August 20-21, 2025
Introduction:
Genome editing has transformed molecular biology by enabling precise genetic manipulation. Yet off-target double-strand breaks (DSBs) remain a concern—particularly in therapies, where the FDA prioritizes genome-wide specificity for patient safety. Edits in functional or regulatory regions may disrupt tumor suppressors, activate oncogenes, or alter essential genes—posing serious risks. GUIDE-Seq (Genome-wide Unbiased Identification of DSBs Enabled by Sequencing) enables sensitive, high-throughput detection of on- and off-target DSBs in living cells, capturing the real genomic context shaped by chromatin, repair, and epigenetic state. The method relies on the integration of blunt-ended double-stranded oligodeoxynucleotides (dsODNs) at DSB sites via non-homologous end joining (NHEJ), serving as molecular tags for enrichment and sequencing. Unlike in vitro assays that overpredict without cellular context, GUIDE-Seq offers a physiologically relevant, genome-wide map of CRISPR-Cas activity for research and safety evaluation.
Presented By:
Jimmy Goncalves, PhD – Senior Research Scientist – Avance Biosciences Inc.
Poster Title:
Digitally Secure Sequencing: Implementing Part 11-Ready NGS Data Security in a CRO Environment
Conference Program:
C4B: Next-Generation Analytical Methods – August 20-21, 2025
Introduction:
Next- and third-gen sequencing are essential in GMP, GLP, and clinical settings, with FDA support for applications such as gene editing analysis and adventitious agent detection. However, meeting data integrity and 21 CFR Part 11 requirements remains a major hurdle. Many sequencing instruments lack built-in audit trails, allowing raw data to be modified without detection. Since the FDA mandates secure, time-stamped audit trails to track all changes, this gap poses regulatory risk. Further complicating compliance, bioinformatics workflows generate dynamic outputs and involve complex, multi-step analyses. These pipelines often lack robust controls and typically require formal validation. As a result, true compliance demands an integrated solution—secure instrumentation, validated pipelines, version control, comprehensive audit trails, and rigorous quality checks.
Presented By:
Apurva Vansadia – Assistant Product Manager – Avance Biosciences Inc.
See you at BioProcessing Summit 2025!
When you partner with Avance Biosciences™, you gain a CRO partner that is creative, collaborative and dedicated to sound science with a focus on the regulatory requirements our partners require. Contact our technical staff to discuss how we can support you in your project!
