Advanced Therapy Medicinal Products (ATMPs), such as oncolytic viruses, are revolutionizing cancer immunotherapy by selectively targeting and killing cancer cells while sparing healthy tissue. However, transitioning these innovative therapies from the lab to commercial-scale manufacturing is fraught with challenges. In this webinar, we explore how to overcome these hurdles and accelerate ATMP development.
Learn more about our ATMP development and manufacturing capabilities
Kate O'Dwyer PhD
Process Engineer II
Our presenter, Kate, holds an MEng in Chemical & Bioprocess Engineering from University College Dublin, Ireland. She began her career at APC as an Engineering Intern and has since advanced to the role of Process Engineer and CMC Specialist. In this capacity, she has contributed to a diverse range of projects spanning both upstream and downstream bioprocess development.
Connect on LinkedIn: https://www.linkedin.com/in/kateodwyer/
ATMP development often stalls in Phase 2 clinical trials due to scalability issues, unacceptable impurity profiles, and a lack of foresight in process design. These challenges highlight the need for a strategic approach that prioritizes manufacturability, scalability, and compliance from the outset.
In this presentation Kate O’Dwyer, one of our Process Engineers and CMC Specialists in The Medicine Accelerator, delves into the project goals, process design, regulatory compliance, and tech transfer considerations, and how the project at the centre of the case study achieved remarkable results such as:
400% increase in viral yield and 90% reduction in cost per dose
Robust and scalable processes that meet patient demand while maintaining high-quality standards
Improved impurity profiles and faster time-to-patient, enabling more patients to benefit from this groundbreaking therapy