Pre-Conference Workshop Day
Tuesday, December 3, 2024
8:00 am Check In & Morning Coffee
Analytical Development
Quality Control
Workshop A
8:30 am Optimizing Surrogate Potency Assays with Effective Implementation & Validation for Cost Effective & Streamlined Processes
Synopsis
Surrogate assays streamline processes and reduce costs compared to traditional cell-based methods. They offer crucial benefits such as cost and time savings, scalability, and improved efficiency, accelerating the translation of cell therapies to clinical use. However, it’s essential to establish a strong correlation between surrogate methods and cell-based assays to justify their use effectively.
Join us to:
- Gain insights into how surrogate potency assays streamline processes and reduce costs, accelerating the translation of cell therapies to clinical use.
- Understand the importance of establishing a strong correlation between surrogate methods and cell-based assays for effective implementation, qualification, and validation.
- Receive practical guidance on developing surrogate potency assays, optimizing efficiency in cell therapy analytical development and looking into protein expression as a surrogate potency marker.
Workshop B
8:30 am Strategies & Designs for Overcoming Product Instability in Quality Control for Streamlined Regulatory Approval
Synopsis
Ensuring the stability of cell therapy products is essential for their safety, efficacy, and regulatory approval. However, detecting and addressing product instability poses significant challenges. This workshop will delve into innovative strategies and methodologies to navigate the complexities of product instability in cell therapy stability studies. From determining critical stability parameters to leveraging advanced analytics, gain insights into optimizing stability assessment protocols and ensuring long-term efficacy.
Join us to:
- Gain insights into critical stability parameters essential for assessing cell therapy products. Learn to establish robust stability study protocols tailored to product characteristics.
- Explore novel methodologies for detecting and addressing product instability. Discuss alternative study designs and innovative stress-inducing techniques.
- Acquire actionable strategies from industry experts. Engage in interactive discussions to exchange ideas and learn from real-world case studies.
10:30 am Morning Break & Networking
Workshop C
11:00 am Navigating Characterization Strategies in Cell Therapy Development with Evolving Insights from FDA Guidance
Synopsis
In the rapidly advancing field of cell therapy, developers face significant challenges in characterizing their products to meet regulatory standards. The FDA has provided evolving guidance on what is required for effective characterization, which includes understanding product attributes, ensuring consistency, and demonstrating safety and efficacy.
Join us to:
- Understand how cell therapy developers are adapting their characterization strategies in response to evolving regulatory requirements, identifying areas for innovation and improvement in current practices.
- Delve into recent FDA guidance on cell therapy characterization, exploring strategies for effectively interpreting and implementing these expectations.
- Discuss approaches for aligning characterization strategies with FDA expectations to ensure compliance and facilitate regulatory approval.
Workshop D
11:00 am Strategies for Potency-Driven Quality Control in Cell Therapy to Maximize Therapeutic Efficacy
Synopsis
Ensuring the effectiveness and safety of cell therapy is critical as the field progresses. Central to this is potency evaluation, encompassing vital functions like mechanism of action, cell-based killing, and more. Crafting robust quality control (QC) strategies involves navigating complexities to align with regulatory standards and therapeutic goals. Translating QC findings to clinical settings is essential for predicting therapeutic outcomes.
Join us to:
- Explore the multifaceted landscape of potency evaluation, delving into vital functions such as mechanism of action, cell-based killing, degranulation, release, proliferation, and persistence, crucial for determining therapeutic efficacy.
- Navigate the complexities of QC strategy formulation, understanding how to select and prioritize functions for monitoring, ensuring alignment with regulatory requirements and therapeutic objectives.
- Gain insights into the translation of QC findings to clinical settings, elucidating the significance of robust potency assessments in predicting cell performance and therapeutic outcomes in patients.
1:00 pm Lunch Break & Networking
Workshop E
2:00 pm Optimizing Analytical Development for Scalable & Efficient Cell Therapy Manufacturing
Synopsis
Optimizing analytical development for scalable and efficient cell therapy manufacturing is essential for ensuring product quality and regulatory compliance. Challenges include the complexity of cell therapies, scalability of methods, integration with manufacturing, and regulatory standards. Developing robust analytical methods that align with manufacturing needs and regulatory requirements is critical for accelerating the translation of cell therapies from research to clinical use.
Join us to:
- Gain insights into how analytical methods evolve throughout cell therapy development, from research to commercialization.
- Learn strategies for aligning assays with manufacturing, enhancing efficiency and product consistency.
- Explore best practices for transitioning from quality assurance to quality control, ensuring adherence to regulatory standards.
Workshop F
2:00 pm Establishing Robust Acceptance Criteria for Improved Product Quality
Synopsis
Establishing acceptance criteria for cell therapy products is crucial for ensuring safety and efficacy by defining standards for parameters like cell viability, identity, potency, and stability during development and testing. However, this process is challenging due to the complex nature of living cells and the lack of standardized methods. While regulatory guidelines provide frameworks, their application requires careful consideration of each product’s unique characteristics. Developing robust acceptance criteria is essential for maintaining product quality.
Join us to:
- Understanding the regulatory guidelines and expectations for establishing acceptance criteria in QC processes, ensuring compliance with industry standards and regulatory requirements.
- Learning practical methodologies, strategies, and risk assessment techniques for defining acceptance criteria, enabling participants to implement effective QC protocols tailored to their specific product development needs.
- Gaining insights into industry best practices, continuous monitoring and evaluation and challenges related to acceptance criteria establishment, providing valuable guidance for optimizing QC processes and enhancing product quality and safety.
