Pre-Conference Workshop Day
8:00 am | Registration & Morning Coffee
9:00 am – 12:00 pm | WORKSHOP A
Navigating the Regulatory Landscape for Plasmid DNA Production to Enhance Compliance & De-Risk Drug Products
Synopsis
In the complex world of pharmaceuticals, understanding the regulatory framework for plasmid DNA production is paramount to ensuring compliance and reducing the risks associated with drug development. This workshop is designed to provide the essential knowledge and strategies required to navigate the regulatory landscape effectively. Gain valuable insights into key regulatory considerations and best practices to bolster compliance and de-risk your modality of choice.
This workshop will address key industry pain points, including:
- How to navigate the intricacies of plasmid DNA production regulation, such as differences in production facility guidelines, and the definition of GMP in the US and Europe
- How to navigate the use of non-GMP plasmids in the manufacturing process for cell and gene therapies, and RNA therapeutics
- The practical approaches and industry-proven methods for ensuring compliance throughout the plasmid DNA production process, from gene and cell therapy to mRNA and DNA vaccines
12:00 pm | Lunch Break & Networking
1:00 pm – 4:00 pm | WORKSHOP B
Optimizing Plasmid DNA Manufacturing Strategy: Striking a Balance Between Internal Versus External Production Capacity
Synopsis
In today’s landscape, selecting the right manufacturing strategy for plasmid DNA production is critical. This workshop delves into whether to build internal manufacturing capacity, or outsource to a contract development and manufacturing organization (CDMO). We’ll explore the factors influencing this choice, including CDMO selection criteria, the cost-prohibitive nature of externalizing, the significant time and financial investments associated with building internal capabilities, and how one can effectively develop an internal process.
We will answer pressing questions such as:
- What are the pros and cons of internalizing versus externalizing plasmid production to make an informed decision about your manufacturing needs?
- What are the greatest challenges when developing an in-house production platform from scratch to support therapeutic pipelines?
- What are the key features that drug developers seek in a CDMO when considering whether to outsource plasmid production?