Abstract:  Robotic systems have been employed for high through-put applications in clinical, toxicological, pharmaceutical and bio-pharmaceutical industries, and in manufacturing processes for accelerated drug screening programs, DNA sequencing, protein manipulations and sample preparations.  Despite of many advantages, robotics implementation in the laboratory environment is still in its initial stages of fancy. The difficulties in adopting the robotic systems vigorously in laboratory atmosphere perhaps might be because not many laboratories can afford the high cost incurred, and the difference in need from laboratory to laboratory that demands the customization of laboratory applications tasks. Adding to further complexity is the daunting task of having to understand some basic programming concepts which is required to write scripts to control liquid handlers and robotic movements of the robotic system for performing laboratory application tasks. Robotics therefore is considered both innovative and intimidating technique limiting in its scope and fringe in its utility benefit. The Division of Product Quality Research at CDER-FDA has developed a strategic laboratory automation initiative with an overarching goal to implement a widely accessible robotics-based automation platform to support regulatory studies in each of the division’s major programmatic areas (i.e., pharmaceutics, biopharmaceutics and manufacturing, etc.). Presently robotic platform is implemented to assess the potential of its use in regulatory settings to semi-automate the MTT and the β-glucuronidase enzyme bioassay methods for near line monitoring of the growth of cells and the production of biopharmaceuticals over the manufacturing product life-cycle. As a model, CHO (Chinese hamster ovary cells) cells were utilized from the division’s bioreactor manufacturing platform. This CHO cell lines were part of the model bioreactor manufacturing process risk assessment program for production of a bio-therapeutic β-glucuronidase enzyme which is a lysosomal storage disease enzyme replacement therapeutic protein. The robotic assay for β-glucuronidase was also developed.<br/> <br/> <br/>

Robotic implementation for MTT proliferative and β-glucuronidase assays to determine bio-therapeutic β-glucuronidase enzyme activity from pilot bioreactor CHO cell lines

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.