Explore the FDA’s new Plausible Mechanism Pathway and how it compares to accelerated approval, expedited programs, and other regulatory routes for rare disease therapies.
Avance Biosciences is proud to participate in Advanced Therapies USA 2025, showcasing our CGMP and GLP-compliant testing services to support the development of next-generation cell and gene therapies.[...]
Avance Biosciences is excited to exhibit at AAPS 2025 PharmSci 360! Discover our CGMP- and GLP-compliant bioanalytical and analytical services supporting next-generation therapies, from RNA and gene/cell therapies to ADCs and exosome-based modalities[...]
Avance Biosciences is proud to participate in the 2025 World ADC Conference, highlighting our CGMP- and GLP-compliant analytical expertise supporting the development of antibody-drug conjugates. From assay development and validation to comprehensive bioanalytical testing, our services empower biopharmaceutical innovators to advance safer, more effective targeted therapies.[...]
The FDA released three new draft guidances to streamline cell and gene therapy development. The documents outline innovative trial designs for small populations, expedited pathways for serious conditions, and improved postapproval methods for monitoring long-term safety and efficacy...
Avance delivers end-to-end NGS workflow compliance with a robust framework for data integrity, pipeline validation, and audit readiness—tailored for regulated environments...
Avance Biosciences™ will exhibit at BPI International 2025 in Boston, showcasing our end-to-end analytical and testing services for biologics, cell, and gene therapies. Visit booth 1508 to learn about our NGS Center of Excellence, offering advanced sequencing, on/off-target detection, and gene editing safety assessments...
Avance Biosciences’ NGS Center of Excellence delivers comprehensive sequencing solutions, including short-read, long-read, and advanced single-cell platforms. Our regulatory-compliant workflows support biologics, gene, and cell therapy programs with high-quality data, enabling informed development...
Avance Biosciences™ will not only be exhibiting (booth #516), but also presenting two posters as part of the Next-Generation Analytical Methods program: Genome-wide Mapping of CRISPR-Cas Off-Target Cleavage Sites via GUIDE-Seq & Digitally Secure Sequencing: Implementing Part 11-Ready NGS Data Security in a CRO Environment...
To support IND-enabling studies, a biotech company needed precise measurement of in vivo gene-editing efficiency in preclinical rat tissues. Avance Biosciences delivered a fully validated NGS amplicon sequencing assay capable of detecting edits as low as 1%, enabling accurate quantification across multiple tissues and guiding data-driven development decisions.
