10.08.25 -- Navigating Regulatory Complexity In Cell And Gene Therapy

Know the differences between designing a viral clearance study for non-enveloped viral vectors versus those for mAbs or recombinant proteins, and learn how to identify and remove viral contaminants.

Viral vector-based gene therapies are redefining medicine. As developers navigate uncharted territory, Sybil Danby of Cytiva highlights three critical areas shaping the journey from discovery to patient access.

Struggling with missing logbooks or tedious cleanroom reviews? Discover how electronic logbooks streamline compliance, boost efficiency, and unlock insights to transform operations.

Effective small surface disinfection in cleanrooms requires adherence to detailed procedures and best practices. Learn about the critical steps, techniques, and validation needed to ensure product safety.

Environmental monitoring (EM) is essential, but it’s only part of the picture. See why a proactive contamination control strategy is key to keeping your cleanroom truly audit-ready.

Current advances in cell, gene, and tissue therapies require a rethinking of how—and where—cleanroom manufacturing facilities could be built, enabling more options for sponsor process control.

Uncover how a mobile cGMP cleanroom was designed and installed on a 53′ tractor-trailer chassis to provide a flexible and efficient cleanroom solution tailored to the company’s needs.

Explore the collaboration that enabled FDA approval of a novel chronic-condition therapy, rescued a high-risk program, and demonstrated a unified “one-team” approach by reworking the sponsor's SAP.