08.10.26 -- Defining Quality In A Sponsor-Owned QTPP Before The CDMO Even Starts

Low AAV productivity and lack of platform processes continue to be key challenges driving AAV production cost up. Explore a robust and scalable suspension manufacturing platform for AAV production.

Digital CMC platforms address tech transfer inefficiencies by unifying process knowledge, reducing compliance risk, and significantly compressing CDMO onboarding timelines.

Successful cell therapy programs rely on evolving, science‑driven partnerships that integrate CMC strategy, deepen rigor over time, and translate complex research into scalable, compliant, clinically ready processes.

NGS transcriptome methods offer a sensitive, animal-free alternative for detecting viruses in cell banks. Analyzing total mRNA transcripts enables precise identification and regulatory compliance.

Rahul Purohit, Ph.D., discusses the challenges and opportunities of scaling non-viral gene-edited cell therapies, with practical guidance for balancing performance, cell quality, and manufacturing readiness.

Manufacturing and quality gaps drive most FDA Complete Response Letters in cell therapy, often stemming from early‑stage decisions and unresolved CMC issues that become major late‑stage approval risks.

Cryopreservation eliminates rigid timelines by decoupling collection from production, providing the flexibility needed to optimize facility use and stabilize advanced therapy supply chains.

High‑throughput affinity screening shows how buffer and pH optimization can boost AAV5 recovery, enabling faster, more reliable downstream process development for challenging serotypes.

Advances in genome engineering and immune evasion are enabling scalable, durable allogeneic cell therapies, overcoming rejection challenges and expanding potential treatments across diverse diseases.