Efficient Batch Record Review For Cell And Gene Therapies

By Fleur Thomas, Senior Quality Manager, and Helmut Lerch, Global Head of Quality, Minaris Regenerative Medicine GmbH (Germany)

The development and manufacture of a cell and gene therapy is a lengthy, intricate process, and a batch of final product requires comprehensive documentation demonstrating full regulatory compliance. Providing documentation that the manufacturing and testing of the batch was undertaken as per GMP is an important measure to ensure product safety and efficacy, but the possible delays to the release and shipment of the medication could have significant consequences for patients in need.

Sponsor companies must perform a full review of a batch record, consisting of several hundreds of pages, in the most efficient way, whilst ensuring that all regulatory requirements have been met. Employing a standardized approach with clear delineation of roles and responsibilities is an essential foundation of efficient batch record review.

Examine how a review standard operating procedure (SOP) which is underpinned by a cross-functional roles and responsibilities matrix can drive continuous improvement of the batch documentation design, identify any potential GDP deficits, and target deficits with discussion/training to avoid potential errors.