Inside Cell & Gene Live "How To Reduce Batch-To-Batch Variation In Cell Therapy Manufacturing"

By Erin Harris, Editor-In-Chief, Cell & Gene
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In case you missed it, our recent Cell & Gene Live, How to Reduce Batch-to-Batch Variation in Cell Therapy Manufacturing, featured expert panelists, Omkar Kawalekar, Ph.D., Head of Manufacturing and Supply Chain at NextGen Therapies Consulting at Deloitte and Donna Rill, Chief Technology Officer at Triumvira Immunologics. During our 60-minute presentation, we took a deep dive into why batch-to-batch variability means that the entire production process is a constant balancing act of adjusting processes to create standardization. There is variability in both autologous and allogeneic cell therapies, and analytical challenges exist as well. Trust me, we broke these topics all the way down.

We addressed batch-to-batch variability as a key challenge in cell therapy manufacturing, and we covered strategies to minimize variability, including implementing robust quality control measures, standardizing manufacturing processes, and ensuring consistency in cell sourcing. We also talked through how advanced analytical techniques and process monitoring can help identify and mitigate sources of variability.

Batch-to-Batch Variability for Autologous Cell Therapies

We kicked off our presentation with a detailed conversation that level-set the root causes of batch-to-batch variability. Variability in the methods used for quality control and testing of cell products can lead to differences in the assessment of cell characteristics, such as viability, potency, and purity.

Next, we moved onto discussing the biggest challenges in batch-to-batch variation for autologous cell therapy manufacturing then onto the operational steps for reducing batch-to-batch variability in manufacturing. And we covered ways to reduce batch-to-batch variation of cell therapy products, particularly Critical Quality Attributes (CQA) such as potency.

Batch-to-Batch Variability for Allogeneic Cell Therapies

At this point in the presentation, Kawalekar and Rill detailed the variability drivers for allogeneic cell therapies as well as the criteria, or non-negotiables, for a healthy donor. We also covered the biggest challenges in batch-to-batch variation for allogeneic cell therapy manufacturing.

Analytical challenges for Auto and Allo 

Overall, analytical science plays a crucial role in improving cell therapy operations by providing valuable insights into cell characteristics, product quality, and process optimization. By leveraging analytical techniques, manufacturers can enhance product quality, ensure regulatory compliance, and ultimately improve patient outcomes. As such, our expert panelists shared the major analytical challenges facing allogeneic cell therapies today as well as how analytical science aids these challenges.

We talked through some of the approaches to control variability of raw materials. And we broke down how apheresis material for autologous cell therapy is subject to variability related to its limited quantity (i.e. product yield), the differences between patients (individual attributes, health status, treatment history), and the differences across apheresis facilities (equipment, collection processes, freezing techniques).  Kawalekar and Rill shared some of the ways in which variability can be reduced for apheresis material for autologous cell therapy.

Data Management and Tracking

An integrated data model and infrastructure are essential for managing the complexities of cell therapy development and manufacturing, ensuring data integrity, compliance, and the ability to derive meaningful insights for improving therapeutic outcomes. Data models should include parameters for quality control and assurance throughout the manufacturing process. This includes monitoring cell viability, purity, potency, and other critical quality attributes. When it comes to setting up the right data models and infrastructure, Kawalekar and Rill detailed not only how but also when data should be collected. They explained how the conversion of data into useful information draws insights to improve operations.

If you were unable to join us live for the event, the entire presentation is available on demand. Be sure to register for our e-newsletter, where we will include the presentation, topic by topic, via short video clips. This way, you can view the presentation one topic at a time and according to your schedule.