Join this webinar to explore how cell and gene therapy manufacturers can accelerate development while maintaining safety, efficacy and quality. Experts will discuss scalable manufacturing, automation, risk mitigation and Quality by Design, alongside the impact of expedited development pathways and emerging technologies on CGT manufacturing.
As CGT pipelines mature and expedited development pathways bring therapies to patients more quickly, manufacturers face increasing pressure to accelerate development while maintaining product quality, safety, and efficacy.
We’ll explore the practical challenges involved in achieving that balance. Industry experts will discuss how manufacturers can build quality into CGT manufacturing from the outset, identify and mitigate sources of variability early in development and develop processes that are consistent, reproducible and scalable.
Topics will include approaches to defining and monitoring critical quality attributes (CQAs), developing robust potency assays, establishing effective analytical and control strategies, and managing comparability through process changes and scale-up.
The discussion will also explore how automation, closed-system processing and Quality by Design (QbD) can help improve process control and reproducibility, alongside the challenges of scale-up and scale-out.
The discussion will also look at emerging approaches including AI-powered digital twins, modular manufacturing and allogeneic platforms, considering where these could help address some of the industry’s ongoing challenges around reproducibility in manufacturing.
What will you learn?
- How to scale CGT manufacturing while maintaining consistency and quality
- Approaches to identifying and mitigating manufacturing and quality risks early
- Approaches to defining and monitoring critical quality attributes
- The role of QbD, automation and closed-system processing in improving manufacturing control
- How accelerated development pathways can affect CMC and manufacturing strategy
- How emerging technologies could support more reproducible and consistent CGT production
Who should attend?
This webinar is suitable for senior professionals involved in CGT development and manufacturing, including:
- Manufacturing and Technical Operations leaders
- CMC and Process Development teams
- MSAT and Manufacturing Science professionals
- Quality and Regulatory leaders
- Process Engineering and Automation specialists
- Technology Transfer and Scale-up/Scale-out teams
Join industry experts to explore how manufacturers can accelerate CGT development while building the foundations for successful commercialisation.
The content presented in these sessions is intended for research use only and is not intended for use in diagnostic procedures. The views and opinions expressed in the recordings are those of the individual presenters and do not necessarily reflect the official policy, position, or claims of Bio-Rad Laboratories. Any clinical applications, test validations, or performance claims discussed are the sole responsibility of the presenting institution or speaker and do not reflect the views or endorsements of Bio-Rad Laboratories.
Any reference to clinical use, patient testing, or performance claims reflects the practices and experience of the individual institutions or researchers and should not be interpreted as endorsement by Bio-Rad.
Dr Susan D’Costa serves as Chief Technical and Commercial Officer of Genezen. She is a molecular virologist with over 25 years of experience, including more than a decade in viral vector gene therapy. Her expertise spans viral vector analytics, process development, manufacturing, and team building. Before joining Genezen, Susan was CTO at Alcyone Therapeutics, leading viral vector CMC, device development, and technology partnerships.
Rob Scott is Head of Consultancy at eXmoor Pharma and an EU Qualified Person (QP). He has more than 25 years of experience across biopharmaceuticals, cell and gene therapies, and GMP quality systems. His expertise spans process development, facility and equipment qualification, QC and QA system development, aseptic validation, audit support and manufacturing compliance.
Is the panel discussion free?
Yes – there is no charge to watch the panel discussion, either live or on-demand.
When will the panel discussion take place?
The webinar will be taking place on 19 November at 3pm (GMT).
Can I watch it later?
The panel discussion will become available to watch on-demand shortly after the live webinar takes place.
What are the benefits of attending live?
You’ll be able to ask the speakers your questions, which will be answered live in the Q&A towards the end of the session.
How long will the panel discussion be?
This panel discussion will last up to an hour.
What do I need to watch this panel discussion?
All you need is a computer with an internet connection. We recommend using headphones if possible if you’re in an office environment.
