EU23CEDEC1/SES103 - End-to-End CCS in ATMP Through Advanced Risk Profiling

The quality of the CCS is highly dependent on the resolution of the available risk data - the more accurate this risk data is, the more targeted and effective these control mechanisms can be. The presentation introduces the Frame-by-Frame Risk Profiling approach for generating end-to-end CCS. Frame-by-Frame Risk Profiling identifies trends and recurrent patterns that indicate potential risks to the process. Process-frames have resulted from contextual and operational aspect assessment of the task and the context in which the process occurs. Accumulation of these process-frames have led to data-based frame library that provides a centralized repository of information that can benefit to inform the assessment process consistently and objectively. Every process-frames incorporate high-resolution risk data which can be used to generate end-to-end CCS for ATMPs. By linking to the Process Frame Library, an end-to-end CCS can incorporate targeted risk mitigation strategies for MBR, work instructions, QA monitoring guidelines, and training, and keep all information consistent across processes and manufacturing sites. Furthermore, end-to-end CCS incorporates Pharma 4.0 technologies such as Virtual Reality in order to train and assess operator behavior. The presentation will also share insights from implementation of Frame-by-Frame Risk Profiling Pilot at Johnson & Johnson CAR-T.