05.28.26 -- Dr. Peter Marks On Why Gene Therapy May Need A New Regulatory Playbook

Accelerate access to high-quality, cost-effective lentiviral vectors with this intensified TFDF-based manufacturing platform, delivering multi-fold yield improvements and scalable, space-efficient production.

Early quality, strong tech transfer, solid data discipline, and risk‑based decisions help accelerate advanced therapy programs and ensure compliance, scalability, and regulatory confidence.

Explore how variability reduction programs improve biomanufacturing by controlling raw‑material complexity, optimizing critical attributes, and boosting productivity through data‑driven partnerships.

Poly(A) tail integrity is critical for mRNA stability and translation. Advanced strategies optimize plasmid design, transcription, and purification to ensure consistent poly(A) control for therapeutic success.

Viral vectors are the indispensable backbone of genetic medicine. Review the fundamental trade-offs and manufacturing strategies for large-scale production of AAV and lentiviral delivery systems.

Discover the emerging tools and technology platforms that are transforming drug development, enabling faster discovery, improved scalability, and greater precision across data-driven manufacturing processes.

What's the best protein expression format? When choosing between protein expression formats such as transient versus stable pools, considerations include speed, cost, titre, and product quality.

See state‑of‑the‑art analytical methods for AAV characterization, key quality attributes to monitor, and approaches for measuring infectivity and full‑to‑empty capsid ratios.

Choosing the CDMO best suited to manufacture your rare disease therapy can be challenging. Ideally, a CDMO will prioritize your goals while working to ensure quality and regulatory success.

Gain valuable insights into the critical role of apheresis in sourcing high-quality cellular material for therapies, and how expertise, protocols, and skilled practitioners can impact patient outcomes.

Turn your inconsistent bioassays into GMP-validated, high-reliability platforms — just like this company that helped a biopharma partner cut failure rates from ~25% to <1%.

Learn how lentiviral vector processes evolve for in vivo and ex vivo CAR‑T, covering yield, purity, scalability, and shifting regulatory demands for safe, consistent systemic delivery.

Structured process development enables scalable GMP adenovirus manufacturing with optimized performance, yield, and control at large scale.