The challenges facing Quality Assurance Teams in Cell Based Therapy Companies

The challenges facing Quality Assurance Teams in Cell Based Therapy Companies

In our previous post about Quality Control Labs in Cell-Based Therapy companies, we discussed how the rise of personalized cell-based medical treatments, exemplified by CAR-T (Chimeric Antigen Receptor T-cell) therapy, is transforming modern medicine. This innovative technology holds great potential for improving treatment outcomes and is reshaping the future of healthcare.

Quality Assurance (QA) teams in cell-based pharmaceutical companies, like those in conventional pharmaceutical firms, play a crucial role in ensuring product quality and consistency. However, these novel therapies present unique challenges for QA teams. One significant challenge is the need for swift review and authorization. This urgency arises from the personalized nature of these therapies, which are tailored to individual patients, eliminating the option of maintaining safety stock levels. Moreover, the critical medical conditions of the patients awaiting treatment, intensify the demand for timely release. The traditional review of manufacturing batch records often involves multiple levels of review by manufacturing and QA (with accompanying rounds of corrections!). This often leads to inefficiencies and bottlenecks. This linear process often results in queues and delays in handling corrections, leading to prolonged release times. Any batch record review and redesign process should have inputs from both manufacturing and QA so that it both supports the process and simplifies the review effort.

QA teams also experience workload volatility due to factors such as production schedules, fluctuations in volume (due to ramp ups), deviations, investigations, and a high volume of non-routine work, such as change controls, owing to the innovative nature of these therapies. To address these combined challenges, it's essential to establish an operating system for the QA process that ensures rapid, reliable release times while balancing workloads and maintaining quality. While some key principles for this system may align with standard QA processes, unique aspects do come into play.

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The Lean QA Solution: Proactive Solutions for Quality Assurance Challenges

A fundamental starting point is the creation of clear, concise documentation designed for its purpose. This should be coupled with a clear understanding of what data/entries need to be reviewed and who is responsible for reviewing specific items. Simplifying or redesigning the batch record process will also reduce corrections and deviations and support real-time review.

Real-time review can represent a significant change in how QA (and manufacturing) teams operate but is critical for improving batch record flow. In this approach, the batch record is reviewed by manufacturing and QA personnel at fixed points or times while it's still within the production process, as opposed to waiting until it's complete. Real-time review allows for immediate corrections, reducing the need for complex correction processes and delays associated with waiting for operators to return to their shifts. Face-to-face interactions between QA personnel and operators during corrections, minimize the risk of misunderstandings. Most entries can be reviewed in real time, though some may require completion of the batch record. Batch record redesign can help identify these different entry types. Real-time review also helps level the workload to match the manufacturing flow. In order to reduce the workload volatility, the QA system would also involve design of rules/guidelines for mixed workstream levelling.

The implementation of a standardized operating system for QA teams is important, especially as these teams transition from focusing on development, validation, and clinical work to a more commercial orientation. This system should integrate principles like streamlined workflow and clear, concise documentation. A lean QA solution enhances efficiency, maintains consistency, and reduces day-to-day fluctuations. It also establishes a framework for predicting future increases in volume or ramp-ups, providing valuable insights into when additional resources (staff, space, etc.) will be required.

In conclusion, while the challenges faced by QA teams involved in Cell-Based Therapy may seem daunting, addressing them proactively is vital to ensuring the safety, efficacy, timely delivery, and cost-effectiveness of these groundbreaking treatments for the patients who depend on them.

No other company has BSM’s knowledge and experience of implementing lean QA teams. We have a proven track record of cutting lead times by 90% and increasing productivity by up to 80%.