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.
Speakers
Jessica Madigan, Director, Business Development, Nucleic Acid Modalities, BIOVECTRA
Jessica Madigan has a BSc in Chemistry with 15+ years of experience focused on nucleic acid manufacturing and development. Jessica played a key role at a start-up CDMO leading to the successful launch of mRNA, plasmid, capping analogs and modified nucleotide products. Jessica also holds a Project Management Professional (PMP) Certification and successfully managed over 30 API manufacturing projects for mRNA early-phase clinical trials. Since joining BIOVECTRA in 2022, Jessica has supported business development efforts for pDNA, mRNA, LNP formulation and fill/finish services.
Message Presenter
Manika Bhondeley, PhD, Senior Scientist, Revolution Biomanufacturing
Manika Bhondeley is a Senior Scientist at Revolution Biomanufacturing, where she leads the development of AI-driven tools for optimizing mRNA design and supports translational workflows spanning construct design, in vitro transcription, analytical characterization and early validation. She brings a rare combination of deep molecular biology expertise and hands-on industry experience across multiple facets of mRNA therapeutics, including UTR engineering and codon optimization, as well as upstream process development and purification strategies.
Before joining Revolution Biomanufacturing, Manika held roles at Kudo Biotechnology and National Resilience, where she improved mRNA translation efficiency, advanced purification workflows and led data-driven process optimization to enhance yields and reduce impurities. Her work has directly contributed to improvements in mRNA performance and manufacturability. Manika’s academic background includes a PhD in Integrative Biology from the University of New Orleans and research experience spanning transcriptional regulation, metabolic pathways and single-cell genomics.
Known for her ability to translate complex science into practical insights, she offers audiences a clear view into how AI-enabled sequence design, rigorous analytical methods and disciplined process development come together to accelerate next-generation mRNA therapeutics.
Message Presenter
Molly McGlaughlin, Chief Executive Officer, Revolution Biomanufacturing
Molly McGlaughlin is the Chief Executive Officer of Revolution Biomanufacturing (RBIx), bringing 29 years of leadership in biologics development, advanced therapeutics and GMP manufacturing in the CDMO industry. She has held senior roles at Fuji Diosynth (Avecia), Vigene Bioscience, Patheon, Mallinckrodt and other global biopharmaceutical organizations, leading teams across process development, GMP operations and commercial readiness.
Molly holds advanced academic degrees in biology, organizational performance and strategic studies. She is also a retired US Army Reserve Colonel who commanded at the brigade level, experience that informs her disciplined, mission-driven approach to building resilient biomanufacturing systems.
At Revolution Biomanufacturing, Molly leads the company’s vision to accelerate nucleic-acid therapeutics through integrated sequence design, novel lipid and LNP technologies and digitally enabled, GMP-ready manufacturing platforms.
Message PresenterWho Should Attend?
This webinar will appeal to:
- mRNA therapeutic, Cell and Gene therapeutics (non-viral gene editing, CAR-T and CAS-9) and vaccine developers (R&D through CMC)
- Process, Analytical and Formulation Development Scientists
- Bioprocess Engineers and Manufacturing Leads
- CDMO Program Managers and Business Development Teams
- Academic and Translational Researchers in RNA design and production
What You Will Learn
Attendees will gain insights into:
- How codon optimization and UTR design influence IVT efficiency, translational output, mRNA stability and manufacturability
- The sequence-level decisions that drive yield, capping efficiency, dsRNA formation and LNP performance
- Practical design principles that strengthen the potency, durability and scalability of mRNA constructs
- Common disconnects between sequence design and GMP production and strategies to avoid them
- Workflows that improve handoffs between R&D, CMC and GMP teams, reducing technical risk and accelerating timelines
Xtalks Partner
BIOVECTRA
BIOVECTRA is a global biotech and pharmaceutical CDMO that specializes in clinical-to-commercial scale production capabilities for: biologics, bioreagents, fermented small molecules, synthetic small molecules, and active pharmaceutical ingredients. Flexibility, creativity, process optimization and compliance are at the heart of our method. With more than 50 years of experience, 550+ employees, and cGMP facilities in Prince Edward Island and Nova Scotia, Canada we assure our programs advance on time and with the highest quality outcomes.
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