FlexiPro™ Chrom Supports GMP Manufacturing of Plasmid DNA & Viral Vectors

As cell and gene therapies advance, manufacturing challenges grow. From plasmids to lentiviral vectors, biopharmaceutical companies need GMP platforms that combine flexibility, scalability, and precision.

The VERDOT FlexiPro™ Chrom system addresses these needs, offering a single-use, multi-scale chromatography platform capable of purifying both plasmids and viral vectors on the same system. By using four interchangeable flow kits, FlexiPro Chrom covers a wide range of flow rates—from 10 mL/min to 560 L/hr—supporting processes from small-scale development to full GMP manufacturing.

Key Advantages for Next-Gen Biologics

• Versatility: One system handles multiple chromatography steps, including capture, polishing, and membrane/resin operations.
• Ultra-Low Flow Kits: Ideal for small-scale GMP plasmid processing and advanced therapeutics.
• Precision Control: Simultaneous regulation of flow and pressure ensures consistent performance, even with high backpressure monolithic columns.
• Specialized Instrumentation: Wide-range conductivity probes (0–500 mS/cm) and dual-wavelength UV allow precise monitoring for plasmid and viral vector purification.
• Single-Use Efficiency: Minimal hold-up volume, easy kit installation (<15 minutes), and reduced cleaning validation simplify operations.

Cellectis Case Study

Cellectis, a clinical-stage biotechnology company developing TALEN®-based cell therapies, faced the challenge of purifying both plasmids and lentiviral vectors efficiently in a GMP environment. Using FlexiPro Chrom, they were able to:

• Consolidate multiple chromatography steps onto a single compact system, saving valuable cleanroom space.
• Purify plasmids using a charged membrane and resin column, achieving high purity while removing host cell proteins, genomic DNA, RNA, endotoxins, and unwanted plasmid isoforms.
• Purify lentiviral vectors on an anion exchange monolithic column with low shear stress, maintaining structural integrity and functional activity of the viral particles.
• Navigate complex workflows with wide salt concentration ranges and simultaneous flow and pressure regulation, ensuring optimal performance across all chromatography steps.

This approach allowed Cellectis to maintain process flexibility, quickly adapt to new product candidates, and streamline GMP manufacturing—from development through commercial scale.

FlexiPro Chrom’s combination of scalable flow rates, advanced analytics, and single-use design makes it a robust solution for GMP plasmid and viral vector manufacturing, supporting the production of cutting-edge therapies efficiently and reliably.

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