Executive Summary
A biotechnology innovator developing a CAR-T therapy faced low and variable lentiviral vector titers that threatened scalability and IND timelines. Through targeted plasmid engineering and structured process development, Minaris Advanced Therapies achieved a 12.5-fold increase in infectious titer. The improved vector performance enabled GMP manufacturing and supported successful IND filing.
Key Takeaways
– 12.5× increase in infectious lentiviral vector titer
– Optimized plasmid design for improved packaging
– Scalable process development from shake flask to bioreactor
– Supported on-time IND filing
Download the case study to explore the development strategy and measurable results.
About This Case Study
The Challenge
Low infectious titers from a lentiviral vector construct limited manufacturing efficiency and introduced risk to a CAR-T cell therapy program. Variability in vector production increased batch demand and threatened IND timelines.
The Approach
Minaris implemented a focused plasmid engineering strategy, developing and testing three optimized transfer plasmid designs. Small-scale screening confirmed improved packaging efficiency before the team advanced to controlled bioreactor process development.
Why It Matters
The optimized construct delivered a 12.5-fold increase in infectious titer, improving manufacturability and reducing production burden. By resolving a core viral vector manufacturing bottleneck, the program advanced to IND filing without delay. This case study demonstrates how integrated lentiviral vector production and process development expertise can accelerate advanced therapy programs.
Who Should Read This Case Study?
– Cell and gene therapy companies developing CAR-T programs
– CMC and process development leaders optimizing lentiviral vector production
– Biotech teams preparing for IND filing
– Organizations seeking viral vector manufacturing and plasmid engineering expertise
– CDMO evaluation teams assessing scalable GMP manufacturing capabilities
