02.24.26 -- STREAM Edition: CGT Regulation In 2026 Moves Toward Disciplined Flexibility And Higher Standards

One challenge for scalable commercial manufacturing is closing and automating the entire process. Core processes may be closed, but peripheral systems remain open, raising failure risk. This approach enables closing and integrating both core and peripheral processes.

Discover a cost-effective, docking station-style mixing platform designed for flexibility. Watch the video overview to explore how modular systems support multiple volume options, providing a streamlined and adaptable solution for diverse bioproduction needs.

 

Driven by urgency, a unique partnership with viral vector experts successfully developed a treatment for an ultra-rare neurodegenerative disorder in just 14 months. Learn how collaborative science and specialized capabilities can bypass traditional delays.

When should you begin validating your storage protocols? In this segment from the Cell & Gene Live digital event, discussion examines the critical timing for stability studies, ensuring cell-derived therapies maintain therapeutic integrity from the initial source to the site.

Reduce complexity and condense your development timelines. This transient transfection platform simplifies analytical processes and process development, offering a reliable, de-risked route to IND filing for advanced viral vector-based therapeutics.

Regulation has matured into a phase of "disciplined flexibility." Industry experts discuss the 2026 roadmap, emphasizing that future approvals now demand more rigorous CMC foundations, clinical evidence, and risk-based strategies to meet higher standards.