03.26.26 -- FDA's 483 Playbook: What It Means And Misses For Pharma Outsourcing

Gain valuable insights into the importance of apheresis in sourcing high-quality cellular material, and learn how expertise, adherence to protocols, and skilled practitioners impact treatment success.

When it comes to furthering AAV's potential in the wider biopharmaceutical pipeline, partnering with a CDMO that can foment an optimal analytical and manufacturing strategy is crucial.

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

A practical USP <1665> and <665> framework helps manufacturers evaluate and manage extractables and leachables risk, supporting quality, safety, and regulatory compliance.

Progress in cell and gene therapy hinges on aligning therapeutic design with scalable, efficient manufacturing to improve accessibility, reliability, and real‑world feasibility across advanced modalities.

A new platform approach streamlines lentiviral vector design and manufacturing, boosting yield, lowering costs, and accelerating access to gene‑modified cell therapies worldwide.

Minute Virus of Mice (MVM) is a more accurate surrogate for AAV2 inactivation. The high susceptibility of Porcine Parvovirus (PPV) may have led to an overestimation of disinfectant efficacy.