05.18.26 -- FDA's First cGMP Enforcement Action On AI Misuse In Drug Manufacturing

Bispecific antibody quality control demands advanced analytics to detect mispaired species, assess structural integrity, and confirm potency, ensuring safety and efficacy across diverse therapeutic applications.

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.

Listen in as Dr. Corey Stanton speaks with Dr. Omar Wahab, Vice President of Bioprocessing at Lonza, about the strategic role of cell culture media in scalable biologics manufacturing.

Explore advanced AAV production platforms that enhance efficiency, scalability, and compliance, paving the way for safe and accessible gene therapies.

Automated, closed cryo‑processing of leukapheresis preserves cell quality and functionality, enabling flexible, reproducible starting material for both autologous and allogeneic CAR‑T manufacturing.

Learn how the following framework can accelerate your viral vector, CAR-T, and iPSC programs, reduce risk, and streamline your path from development to commercial manufacturing.

For sensitive biologics and viral vectors, risk extends beyond simple contamination. Utilizing inert barrier films on contact surfaces reduces compound migration and adsorption, maintaining dosage accuracy.

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.

Downstream AAV manufacturing remains a critical bottleneck, and overcoming it requires true platforming that couples standardized processes with scalable CMC systems to improve speed and cost.

Vector redesign and regulatory hurdles can add years to development timelines. A single-partner approach helps streamline the process, secures timelines, and ensures smooth tech transfer to the clinic.

Delve into why investing in a comprehensive feasibility program for GOI testing is not just beneficial, but absolutely essential for cell and gene therapy companies.

See how genome engineering and iPSCs are being used to overcome the critical challenges of durability and host immune clearance in both clinical and preclinical settings for allogeneic cell therapies.