In this webinar, we present opportunities to optimize scale-up of the pDNA process for mRNA applications. During the critical cell lysis step, alkaline solutions and mechanical stress risk pDNA degradation, and highly viscous solutions may cause heterogeneities or require extensive mixing. We explain how to overcome these cell lysis challenges – maximizing product yield and quality while minimizing residual impurities, managing product/waste volumes, and ensuring process step robustness.  

Alkalizator, an automated in-line lysis system with a closed single-use loop is explored, tailored for process development up to pilot-scale within a GMP environment. It features advanced mixing control, enabling automatic, continuous processing of up to 500 liters of resuspended cells per working day. We will present detailed in-line lysis results, including impact on pDNA quality. 

What You Will Learn:

1. Understand the challenges associated with alkaline lysis in pDNA extraction 

2. Compare in-line lysis systems to traditional batch lysis methods 

3. Explore at-line in-process control strategies tailored for managing complex crude lysis samples