HOUSTON, December 3, 2025 /PRNewswire/ — Avance Biosciences today announced the opening of its new Potency and Cell-Based Assay Center of Excellence, a purpose-built facility designed to expand and centralize the company's capabilities in potency and functional cell-based assays under GMP compliance [...]
Next-generation sequencing (NGS) outperforms Sanger for cell therapy testing, offering higher sensitivity, full-length vector analysis, and population-level variant detection to ensure genomic integrity, regulatory compliance, and scalable quality control...
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...
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...
