12.17.25 -- Advanced Therapies USA Taught Me Why Platformization Is No Longer Optional

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

CMC failures are a top reason for BLA rejections in cell and gene therapy. Learn proactive strategies to spot subtle quality gaps and ensure your manufacturing aligns with strict FDA expectations.

Life sciences compliance is complex and ever-changing. Discover how modern solutions can streamline processes, reduce friction, and keep your organization ahead of regulatory demands.

Generate GMP-compliant mesenchymal stem cells (MSCs) at scale with a closed, automated workflow. Assimilate how to optimize MSC harvest yields and ensure trilineage differentiation.

Explore Annex 1 updates on contamination control in pharmaceutical cleanrooms, emphasizing cleaning consistency, training, advanced tools, and technologies to achieve regulatory compliance.

See how streamlined workflows and enhanced collaboration between data managers and medical reviewers can boost clinical trial efficiency, improve data quality, and ensure patient safety.

Uncover how a unique partnership model helps cell and gene therapy developers accelerate progress, reduce risk, and bring transformative therapies to market faster.