How Sequence Engineering and GMP Integration Accelerate Therapeutic Success

Developers of mRNA therapeutics face an increasingly complex landscape: rising expectations for potency and durability, evolving regulatory guidance and persistent challenges in scaling from exploratory design to GMP manufacturing.

While attention often focuses on downstream process improvements, many of the most influential determinants of expression, manufacturability and clinical performance originate at the sequence level.

This webinar examines how sequence-level decisions shape mRNA performance and how aligning design with manufacturing expectations can reduce development risk.

The featured speakers will examine how rational sequence engineering, particularly codon optimization, UTR selection and regulatory element tuning, shapes the performance and production readiness of mRNA constructs.

The session will outline how specific sequence features influence transcription efficiency, IVT yield, capping outcomes, dsRNA formation and translational efficiency, drawing on experimental findings from RBIx’s RevSelect™ platform. Beyond sequence design, the webinar will explore how upstream decisions translate into downstream implications across development, tech transfer and GMP manufacturing.

The speakers will discuss practical considerations for aligning sequence optimization with real-world process capabilities, analytical expectations and quality requirements for pDNA, mRNA, LNP formulation and sterile fill/finish. Examples will illustrate where misalignment between design and production often leads to delays and how integrated workflows can help avoid those pitfalls.

Participants will gain a clearer understanding of:

• How to evaluate codon and UTR choices for manufacturability and potency
• Which sequence-level attributes most strongly affect IVT efficiency and mRNA stability
• How early data packages can support smoother process development and regulatory readiness
• Strategies for improving continuity between design, development and GMP production

Attendees will come away with actionable insights that can help de-risk development programs, reduce iteration cycles and improve the likelihood of successful IND-enabling production.

Register for this webinar to learn how mRNA performance can be strengthened through sequence design and GMP-aligned development strategies.