This poster, developed in collaboration with NecstGen, outlines a study aimed at creating a scalable, GMP-ready downstream processing (DSP) platform for lentiviral vector (LV) gene therapies. The study’s primary goal is to tackle the high manufacturing costs associated with LV-based therapies by enhancing DSP yields, thereby improving accessibility.
Sartorius BIA Separations’ products, notably the CIM QA and DEAE Monolithic 96-well plates and 1 mL CIMmultus QA columns, were integral to the study. They were employed during the ion exchange chromatography (IEX) development phase, where Design of Experiments (DOE) was utilized to optimize chromatography conditions. Their application resulted in an impressive 85% transducing unit (TU) recovery and a 2.20 host cell protein (HCP) log reduction value, with residual dsDNA concentrations falling below the assay’s lower limit of quantification (LLOQ). This underscores the monoliths’ capability to significantly enhance purification efficiency and product quality.
The study concludes that integrating DOE methodologies with Sartorius BIA Separations’ monoliths markedly improved process understanding and LV recovery across various DSP unit operations. This advancement led to a reduction in manufacturing costs per dose, underscoring the monoliths’ effectiveness in optimizing LV DSP processes and contributing to more cost-effective gene therapy solutions.
