Lab Excellence for CAR-T Cell Therapy

CAR-T Therapy, A Medical Paradigm Shift: Unique Challenges for Quality Control Labs

The emergence of personalized cell-based medical treatments, such as CAR-T (Chimeric Antigen Receptor T-cell) therapy, marks a paradigm shift in modern medicine. This revolutionary technology promises greatly improved therapeutic outcomes, using tailored cell-based medical approaches for the future of healthcare. As an increasing number of these treatments transition from development to regulatory approval, it is becoming clear that the quality control labs within cell-based pharmaceutical companies, confront distinct challenges when compared to labs responsible for testing and releasing more conventional pharmaceutical products.

The biggest challenge is the need for speed! As these unique therapies are individually produced for specific patients, there is no possible way to build any safety stock. Furthermore, these patients are typically in a critical medical condition and need the treatment as soon as possible. In addition, the methodologies and techniques employed in these labs are inherently complex, demanding specialized equipment and expertise.  This complexity places a strain on both resources and workforce capabilities. Moreover, these complex methods often yield higher failure rates, which, when combined with the tight timeframes, can result in high-pressure and demanding laboratory environments.

Image

Overcoming Challenges in Cell-Based Therapy Labs

As the demand for these therapies continues to rise, quality labs must also reliably expand their capacity. So, alongside the completion of testing and release of commercial product, Labs must validate new equipment, transfer methods and train new scientists to support ramp ups and projects in manufacturing. This blend of routine and non-routine/project-related work generates inherent volatility within the labs.

The way to tackle these combined challenges is to develop a scalable operating system for the lab that utilizes levelling, flow and standard work. The development of a lean lab solution can ensure efficient consistent turnaround times while also reducing the day-to-day flux felt within the lab. Critically, it also establishes a framework for modeling future increases in volumes or ramp-ups, providing crucial insights into when additional resources (equipment, staff, space, etc.) will be required. Implementing a standardized operating system for the lab is equally vital as labs, which were traditionally focused on development and clinical work, shift their emphasis toward more commercial activities.

Collectively, the distinctive challenges faced by Quality Control Labs in the realm of Cell-Based Therapy may appear daunting, and a seemingly straightforward solution might involve increased spending and resourcing. However, addressing these challenges early is pivotal to guaranteeing 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 in Cell Therapy Labs. We have a proven track record of cutting lead times in Cell Therapy Labs by >50% and increasing lab capacities by 300%.