Enhancing downstream processing in lentiviral vector production

The pharmaceutical sector is experiencing growing interest in advanced therapeutics such as gene therapy and viral vaccines as novel approaches for treating genetic disorders and other conditions. Lentiviral vectors serve as an essential tool for gene delivery, though meticulous preparation is necessary to guarantee safe, high-quality production that maximises viral particle yield while maintaining high purity levels.
Manufacturing involves a complex, multi-stage process that can present numerous challenges, especially during downstream purification. To achieve optimal impurity elimination, methods like chromatography are employed. This technique supports scalability, whereas traditional approaches such as ultracentrifugation are unsuitable for downstream production of lentiviral vectors.

Monolith-based anion exchange chromatography

As the pharmaceutical industry works to tackle these obstacles, many companies are pursuing advanced solutions to improve their downstream workflows. A recent case study from Sartorius BIA Separations demonstrates how incorporating a monolith-based anion exchange chromatography (AEX) step can boost purification performance.
The publication centres on optimising the manufacturing platform of cell and gene therapy specialist NecstGen. In collaboration with Sartorius BIA Separations, the Netherlands-based contract development and manufacturing organisation NectsGen aimed to determine whether TU recovery exceeding 60 percent could be achieved, along with a greater than 100-fold decrease in impurities.
The study outlines how the optimisation enhanced transducing unit recovery while reducing host cell protein and residual dsDNA concentrations. With the ability to improve recovery of infectious lentiviral vectors, this alternative chromatography approach offers an efficient and cost-effective option for downstream processing.

Read 'A Scalable and GMP-Ready Downstream Process for Lentiviral Vectors' in full