Many mRNA programs move quickly at the research stage but run into preventable problems long before GMP manufacturing. Early work often suffers from inconsistent linear DNA templates, unstable IVT reactions, dsRNA related quality failures, and research grade materials that do not translate to later phases. These upstream issues usually appear only during scale up, triggering delays, costly rework, and comparability challenges that could have been avoided with stronger early stage decisions.
This webinar focuses on the high impact choices that determine whether an mRNA program advances smoothly or becomes stuck. We will explore how template design, methods for generating linear DNA, and the setup of IVT processes influence purity, reproducibility, and overall development performance. You will learn how early teams can choose research grade materials that still support future transition to GMP, and where seemingly minor decisions can quietly undermine scalability later.
We will also highlight practical ways to future proof mRNA workflows based on real development experience. This includes how emerging cell free enzymatic DNA technologies such as synthetic linear DNA platforms like Aldevron’s Alchemy can shorten development timelines and reduce plasmid related variability without promotional framing. We will outline how to align research methods with GMP requirements, build stronger analytical foundations, and reduce risks created by template inconsistency or supply chain limitations.
If you are advancing an mRNA therapeutic, this session will give you clear tools to avoid known pitfalls and scale with confidence. You will gain practical decision guides, best practice frameworks, and actionable steps that help improve reproducibility, comparability, and readiness for GMP manufacturing so you can move quickly without exposing your program to avoidable delays.
Key Learning Objectives
- Identify early‑stage pitfalls specific to mRNA, including: template quality, IVT variability, dsRNA formation, capping and poly(A) control.
- Apply phase‑appropriate material selection for linear DNA templates, including when and how to transition from research‑grade to cGMP materials while preserving comparability.
- Design fit‑for‑purpose QC and analytical strategies for mRNA (e.g., integrity, dsRNA, 5′ cap, poly(A) tail, residual DNA and enzymes) to maintain consistent product quality as batches scale.
- Plan for supply‑chain and process scalability, including evaluation of enzymatic, cell‑free linear DNA synthesis technologies to reduce lead times and variability from research through cGMP.
