Presented at ESACT, June 2013, Lille, France
Implementation of a Predictive Screening Strategy for Cell Cloning by Automation and Parallelization
Anke Mayer-Bartschmid, Ph.D., Senior Scientist, Global Biologics, Bayer Pharma AG
Despite many advances and novel techniques, cell line development is often rate-limiting in the overall progress of a specific project. To save on overall project timelines, it is Bayer’s approach to push up cell line development into late research phase to have a high performing cell line ready before entering into clinical development. This comes at the expense of having to perform cell line development for multiple clinical candidates for a given project at the same time, with project load ever increasing as often observed in industry. To overcome these limitations the workflow has been optimized including a compact flexible automation platform as key component with integrated data management connected to our Biologics data platform. A new automation friendly cell line development workflow was created aiming at enhanced predictivity for scale-up while enabling automate screening of high numbers of different clones. Key steps were tested manually. The newly deigned workflow is being transferred onto a specifically designed automation platform. The newly designed workflow was manually tested and yielded clones of good productivity. An automation platform consisting of different liquid handlers, a cell imaging system, an incubator, a cryo vial decapper and a robo arm was established. First test runs were successfully started. The automation enables an efficient high throughput cell line development process. Appropriate data management is employed to cope with the associated increase in complexity of several candidates/projectes in parallel screening programs. A stringent workflow has been devised which is amenable to automation and still compatible with predictive clone selection and early assessment of product quality attributes.