8:00 am Check-In & Coffee
8:10 am Chair’s Opening Remarks
9:00 am Panel Discussion: Exploring Current Challenges in Cell Therapy Analytical Development
Synopsis
- Addressing the multifaceted nature of analytical development, which encompasses assay development, method validation, and quality control measures tailored to the unique characteristics of cell therapy products
- Navigating evolving regulatory landscapes and lacking standardised guidelines complicates demonstrating product safety, efficacy, and quality
- Embracing emerging techniques like single-cell analysis and multi-parametric flow cytometry offers promise in overcoming challenges and improving product characterisation
Ensuring Comparability & Reproducibility for Fast, Robust & Cost-Effective Assays
9:45 am Essential Design Strategies for Crafting Cost-Effective Potency Assays
Synopsis
- Clarifying potency definitions for specific products, emphasising tailored assay design reflecting product mechanisms and therapeutic targets
- Implementing standardised protocols and rigorous validation to enhance assay consistency and reproducibility across batches
- Exploring innovative technologies and optimisation methods to reduce assay costs while preserving quality and sensitivity
- Incorporating multiplexing techniques into assay design to simultaneously measure multiple potency parameters within a single sample, maximising efficiency and cost-effectiveness while providing a comprehensive assessment of therapeutic efficacy
10:15 am Morning Break & Speed Networking
Synopsis
As this community re-unites for the third time, this session will provide valuable networking time with your peers, enabling you to forge new and lasting connections
11:15 am Elevating Cell Therapy Analytical Development: Harnessing Single-Cell Assays for Enhanced Characterisation
Synopsis
- Exploring how single-cell assays provide insights into the heterogeneity and functional diversity of therapeutic cells, enabling a more comprehensive understanding of cell therapy products and facilitating optimisation of manufacturing processes
- Discussing how single-cell assays enable real-time monitoring of critical quality attributes (CQAs) and early detection of deviations from specifications, enhancing quality control measures and ensuring the production of safe and efficacious cell therapy products
- Highlighting the role of single-cell assays in biomarker discovery, patient stratification, and personalised treatment approaches, facilitating the development of tailored cell therapies with improved therapeutic outcomes
11:45 am Roundtable Discussion: Navigating the Challenges of Comparable Assays in Cell Therapy to Ensure Consistency & Validity
Synopsis
- Addressing inherent differences in cell therapy products, such as cell sources and manufacturing processes, which complicate the development of comparable assays
- Highlighting ongoing initiatives to standardise assay protocols and techniques, aiming to improve comparability and reproducibility across different products
- Discuss regulatory requirements for demonstrating assay comparability, emphasising the importance of meeting regulatory expectations, and implementing quality control measures
12:30 pm Lunch Break & Networking
Ensuring Product Safety & Quality for Enhanced Confidence in Reliability & Effectiveness
1:30 pm Harnessing Machine Learning for Enhanced Quality Control & Anomaly Detection in Cell Therapy Manufacturing
Synopsis
- Explore how machine learning empowers predictive modelling of product quality attributes, leveraging historical data to anticipate deviations in real-time and proactively maintain consistency in cell therapy manufacturing processes
- Delve into the role of machine learning algorithms in detecting anomalies and deviations from expected patterns, allowing for rapid identification of process failures or product inconsistencies. By flagging anomalies, ML-based systems enable timely corrective actions to minimise downtime and mitigate the risk of product loss
- Discuss the transformative impact of machine learning on quality control and anomaly detection, enabling cell therapy manufacturers to implement proactive measures that enhance process efficiency, product quality, and regulatory compliance
2:00 pm Establishing a Robust Stability Program for Autologous Cell Therapy Products
Synopsis
- Determine key stability parameters such as cell viability, potency, identity, and purity to establish the stability profile of autologous cell therapy products
- Develop comprehensive stability study protocols, including storage conditions, sampling schedules, and analytical methods, to assess the stability of cell therapy products over time
- Execute stability testing according to regulatory guidelines, ensuring compliance and generating data to support product shelf-life determination and regulatory submissions
2:30 pm Afternoon Break & Networking
3:00 pm Roundtable Discussion: Navigating the Chicken & Egg Dilemma – Ensuring Analytical Methods Detect Product Instability in Cell Therapy Stability Studies
Synopsis
- Explore the challenge of correlating traditional stability measurements, such as vector titer, with functional potency in cell therapy vectors.
- Discuss the importance of functional potency as a critical quality attribute and the need for innovative approaches to assess it accurately over time
- Examine alternative study designs for stability indicating studies, including deliberately inducing stress on vectors to evaluate their functionality under suboptimal conditions.
- Discuss the advantages and limitations of these approaches in providing insights into the long-term stability and efficacy of cell therapy vectors
- Highlight the role of predictive analytics and computational modeling in predicting the stability and functional potency of cell therapy vectors.
- Explore how advanced data analytics techniques can aid in optimising storage conditions, minimising degradation, and ensuring consistent vector performance throughout manufacturing and storage processes
3:30 pm Revolutionising Quality Control: Harnessing Advanced Data Analytics for Real-Time Monitoring in Cell Therapy Manufacturing
Synopsis
- Real-time monitoring is a way to immediately identify potential process or quality deviations, but it can be a challenge to implement. Discuss how to move your monitoring closer to the ideal state from where you are now
- Explore the use of predictive modelling techniques, such as machine learning and AI, to anticipate potential quality issues based on historical data trends. This enables proactive decision-making and process optimisation to prevent quality deviations before they occur
- How the integration of advanced data analytics into quality control processes enhances process control strategies, leading to improved efficiency, consistency, and reproducibility in cell therapy manufacturing