08.13.25 -- Accelerating NAMs For A Human-Based Future In CGT Development

This playbook provides a concise yet comprehensive roadmap for navigating Europe’s multifaceted regulatory environment when conducting gene therapy trials involving GMOs and CDx.

Explore essential QC strategies in AAV gene therapy and learn how to address rcAAV detection, viral clearance per ICH Q5A, and impurity profiling using NGS to meet evolving regulatory demands.

Advancements in high-sensitivity residual DNA testing enhance the precision of plasmid DNA purity analysis, ensuring compliance with regulatory standards critical for manufacturing processes.

Ensure your ATMP facility meets the latest Annex 1 standards for cleaning & disinfection residue control with the help of practical guidance and a case study detailed in this presentation.

Cell and gene therapies are revolutionizing medicine, but outdated manufacturing methods are slowing progress. Discover how modernizing CGT production can unlock the full potential of life-changing treatments.

Humidity is a critical yet often overlooked factor in cell culture. Learn how it impacts cell viability and discover practical strategies to maintain optimal conditions for reliable results.

Discover the key fabrics used in cleanroom wipes and how they impact performance, as well as explore substrates, manufacturing methods, and essential attributes to help you choose the right wipe.

It was imperative for a large European CMO that produces multiple biologic drugs to select the right product quality and value for each customer to comply with the August 2023 revision to the EU GMP Annex 1.

Discover how Droplet Digital PCR (ddPCR) offers a precise analysis of AAV capsid content, outperforming analytical ultracentrifugation (AUC) in distinguishing therapeutic genomes from contaminants.

By integrating automation into manufacturing workflows early, organizations can accelerate timelines, reduce resource strain, and build more reliable, scalable, and compliant production systems.