Pre-Conference Workshops (am) & Main Conference Day 1 Plenary (pm)Wednesday, 26 February 2025

Workshop will cover the following topics:

The workshop will provide insight into decisions made to enable a multi-product facility that can accept many oligonucleotide types/designs and scales, all the while ensuring proper alignment of large scale and downscale processes. Critical Quality Attributes are suspected to influence efficacy, safety, and quality of final products, therefore consideration of CQAs for large scale manufacturing will be discussed. Participants will gain an insight into Large Scale manufacturing of oligonucleotide API and to the design of a facility. Major themes of the workshop will include:

• Large Scale Manufacturing: Challenges and Solutions
• Designing a Facility: Challenges and Solutions
• Critical Quality Attributes (CQA): How to Maintain during Upscaling

Who should attend?

Anyone interested in understanding the challenges that might exist if oligonucleotide manufacturing were to be build-up in-house rather than depending on a CDMO. Manufacturing personnel, quality assurance (QA), and project management (PM) would realize the most benefit out of this workshop.