2026
In this webinar, attendees will explore how manufacturing success of RNA therapeutics depends on:
- Precise control of quality of raw materials.
- In vitro transcription (IVT) reaction conditions.
- Purification strategies applicable across different constructs.
Efficient mRNA and saRNA production strategy integrates rapid at-line analytics to monitor IVT kinetics, enabling data-driven endpoint selection and feed strategies that raise yield and batch-to-batch consistency. A Quality by Design approach maps critical IVT factors -NTP/Mg2+ ratio, polymerase selection, temperature and time, template design, and capping strategy to critical quality attributes (CQAs) and cost, defining a robust design space that optimizes productivity without compromising quality.
Downstream processing requires scalable, high recovery purification tools and techniques that effectively remove double-stranded RNA, RNA fragments, residual reaction components (NTPs, T7), to reduce immunogenicity and increase cellular potency for both mRNA and saRNA. Affinity (Oligo dT), multimodal and reverse-phase chromatographic solid supports each offer technical advantages and practical challenges that have to be understood and managed in manufacturing environments.
Universal requirements (integrity, dsRNA burden, enzyme and NTP residuals) and format-specific needs (capping for mRNA; long-transcript handling and hydrolytic potential of saRNA) demand decision frameworks for selecting appropriate IVT strategies and purification approaches. A successful mRNA platform design results in a manufacturing approach that scales efficiently and accelerates onboarding of new RNA constructs translating bench-top control into reliable, multi-product production platform.
Speakers:
Rok Sekirnik, Head Process Development mRNA | pDNA, Sartorius BIA Separations
Rok graduated with a degree in chemistry from the University of Oxford, where he also completed his PhD. His team at Sartorius BIA Separations focuses on developing high purity, cost-effective production and purification approaches for pDNA and mRNA.
