2024 - Accelerating Viral Vector Manufacturing: The Use of Automation from Early Stage to QC Release

The production and commercialisation of advanced therapy medicinal products (ATMPs) such as lentiviral vectors present unique challenges in design, production, purification and quality control (QC) release testing when compared to traditional pharmaceutical compounds and even other biologics such as monoclonal antibodies.
Optimal production is heavily dependent on the concentration and ratios of the plasmid DNA components contributing to the transfection process. Improving titres can determine whether a new gene therapy product is commercially viable. A considerable amount of research is aimed at establishing the best titre and one of the ways to do this is by ensuring optimal transfection ratios that can improve the productivity or recovery of upstream/downstream platform processes.
Furthermore, many of the analytical methods employed require days or weeks to complete often with multi-step cell culture combined with quantitative readouts. Lengthy protocols, operator-to-operator variability and a heavy dependence on manual setup are common shortfalls.
Lab-based robotics and digital tools enable bench scientists to work more efficiently, generate more robust data and reduce time-to-insight. Automation in both research and good manufacturing practice (GMP)-regulated environments increases assay throughput, robustness, repeatability and reduces operator’s hands-on-time. Moreover, design of experiments (DoE) and multivariate systems optimisation helps identify optima at a speed that would be impossible using manual methods. Such cutting-edge ways of working help reduce time-to-market and deliver scalable, cost-effective, viral vector drug products.
Register for this webinar to explore how advanced robotics, digital tools and design of experiments are revolutionizing viral vector manufacturing, optimization and QC release testing.
Keywords: Drug Development, Clinical Research, CRO, ATMPs, Advanced Therapy Medicinal Products, Viral Vector, Viral Vector Manufacturing, Cell & Gene Therapies, CDMO/CMO, CGT