Pre-Conference Workshops

Tuesday, 23 August | London, UK

WORKSHOP A

Analytical & Process Technology Transfers: Demonstration of
Analytical Robustness & Product Comparability

10:00am - 1:00pm

Analytical and process transfers are generally required at some point during the development of a medicinal product. Indeed the majority of ATMPs are in development in SME organisation that may not have manufacturing capability in-house, requiring an inevitable transfer of the R&D process to a contract manufacturing organisation or manufacture within a GMP facility at a hospital. It is critical to establish analytical robustness and product comparability to ensure the quality of the product is aligned with that generated for pivotal non-clinical studies (for FIM studies) or historical clinical batches manufactured at a previous CMO/hospital.

Attend this workshop to:

• Explore the basic requirements of a successful tech transfer
• Understand how to demonstrate analytical and process robustness
• Considerations for comparability protocols to support your tech transfer
• Critical quality attributes for consideration
• How to define acceptance criteria that demonstrate comparability

WORKSHOP B

Developing a Successful Potency Assay for Cellular Therapies to Determine Product Activity

2:00 - 5:00pm

Potency assays are an essential concept in determining the quality of any biological medicinal product/biologic. Extending this concept to cell, gene and tissue products is more challenging and often the most difficult aspect of
characterising these products. The relevance of the approach taken is often challenged by regulators both during development and when seeking market approval.

Attend this workshop to:

• Learn what potency assays are and why we need them
• Understand the central role of potency assays in biological characterisation
• Address metrological considerations
• Review reference materials
• Highlight examples of potency assays for approved ATMPs