One of the questions that release by exception raises is safety. How can CGT manufacturers be certain that all released batches are safe for patients? CGT manufacturers and automation technology providers would need to validate the equipment first – not a trivial activity, but one that can unlock key long-term manufacturing benefits.
In many cases, cell therapies are a patient’s final chance at survival. Reducing the time needed to produce a high quality, safe, and efficacious dose is important. Based on published information for αCD19 CART-T therapies for example, up to 10% of manufacturing runs routinely fail.[iii]
By employing release by exception methods afforded by automation platforms, CGT manufacturers could set up alarms and predefined triggers to alert when manufacturing runs are not meeting specified standards. In this way, the industry could move away from lengthy and costly reviews of every single batch, while still upholding high quality standards.
In our new guide, we dive further into release by exception, finding the right manufacturing automation inflection point, automation strategies for CGT manufacturers, building a robust supply chain and more.