Production of mRNA involves complex IVT mixtures, including target molecules, process- and product-related impurities, all with similar biophysical characteristics. Designing a correct hardware setup for reproducible analytical separation of these large biomolecules is a significant challenge. In this session, we explore innovative solutions for streamlining mRNA production.
Customer experience highlight:
Michael Daume, Group leader, Downstream Process Development for Nucleic Acids at WACKER Biotech, will discuss how the company develops novel manufacturing technologies and processes for both RNA and DNA manufacturing. These developments require sophisticated and easy-to-use analytical methods, such as HPLC-based techniques. In this presentation, Dr Daume will discuss how WACKER Biotech uses PATfix to gain valuable insights into the development of novel mRNA processes.
Feature demonstration:
In this presentation, we analyze in vitro transcription (IVT) reaction time points, providing insights into reaction kinetics by monitoring critical IVT components. The PATfix software simplifies sample visualization, enabling precise quality assessment and impurity identification. Its wide mRNA linearity range ensures accurate quantification through calibration curves. Additionally, the platform includes methods for polyadenylated mRNA quantification and robust quality control, separating samples by size to reveal abortive transcripts, target size molecules, and double-stranded RNA.
- Understand the complexities of mRNA production and the challenges associated with separating large biomolecules
- Learn how to accelerate your process development workflows with rapid feedback (5–15 minutes per sample) and user-friendly software for data processing, visualization, and sharing
- Hear from scientists at WACKER Biotech, who have successfully implemented these solutions to optimize their mRNA production processes
- Participate in an interactive Q&A session to get your questions answered and gain deeper insights into improving your mRNA production
This webinar is part of the “Biopharmaceutical analytics unveiled: expert insights and customer success stories” virtual event. To view the other sessions, click on the links below:
Session 1- Enhancing pDNA Production for Gene Therapy: BioNTech
Session 3 - Advancing LNP characterization for drug delivery: NeoVac
Session 4 - Accelerating AAV process development: NCSU BTEC
Michael Daume
Group Leader, Downstream Process Development for Nucleic Acids at Wacker Biotech
Michael finished his Master studies in Molecular Biology at the Philipps University in 2013. He continued his research in the field of “Small RNA Biology” at the Max-Planck-Institute for Terrestrial Microbiology in Marburg and received a PhD degree in 2018. Afterwards, Michael started his professional career as a Process Engineer at Juno Therapeutics, a Bristol-Myers-Squibb company, developing DSP processes for products used in CAR-T cell therapy. In 2023, he returned to nucleic acid research and started working as a research group leader for DSP development for pDNA and RNA purification processes at WACKER’s Corporate R&D in Munich. He is a passionate chromatographer and happy to share some analytical data obtained during mRNA process development.
Blaz Bakalar
Product Manager, PATfix® Platform at Sartorius BIA Separations
Blaz completed his BSc in Biochemistry at the University of Ljubljana, Slovenia, with the program having a heavy focus on laboratory methods widely used in the pharmaceutical industry. He obtained his PhD at NTU Singapore, with a focus on nucleic acid biophysics. In 2020 he joined Sartorius BIA Separations as the PATfix product manager. The PATfix analytical platform combines hardware, software and BIA analytical know-how into a single platform package, making his previous experience a valuable contributor in steering the product towards success.