Fast Lane To Market: A 3-Stage Exploration Of CGT Process Development

By Monika Pema and Francesca Rossetti, AGC Biologics

For sponsors, setting your CGT product up for regulatory viability and commercial success means investing the time and budget to empower process design, as well as on-time planning of process performance qualification (PPQ) and continued process verification (CPV) activities. While shortcuts are difficult to create due to GMP requirements, a CDMO that offers sponsors a platform process and/or platform analytical methods — built on the foundation of a deep scientific background and understanding of the CGT processes — provides sponsors significant advantages versus starting from scratch. These advantages can ease and accelerate process design, PPQ, and CPV.

Product and process development typically follow a predictable formula: complete the minimum activities necessary to ensure process suitability and product safety. Next, advance to GMP production for early-phase clinical trials, which are usually the first major project milestone, and then leverage that progress to raise more funds. Acknowledging that this paradigm is unlikely to change, it remains important to consider additional activities during early development to bolster your organization’s process knowledge.