(249e) Enabling Agile Process Development and Novel Chemistries through Flow Processes

Abstract: For the last two decades continuous manufacturing (CM) and flow chemistry have been constant topics of conversation in the pharmaceutical industry. Yet, despite environmental, economic, and time-to-market benefits, the adoption of CM technologies still faces resistance. Reasons for this include a lack of experience implementing CM processes, a natural propensity to stick with the status quo, build-up of appropriate infrastructure from lab to plant, and concerns around filing strategies. In a partnership between our Process R&D and Environment Health and Safety we are investigating technology and workflows to address the first two limiting factors. To address these constraints, we have developed a strategy for evaluating, developing, and applying CM technologies across our small molecules and antibody-drug conjugate pipelines. In cooperation with external vendors, we are developing a walk-up flow chemistry bench equipped with a variety of fluid dosing, reaction, and Process Analytical Technologies (PATs) that will enable chemists from across the company to easily evaluate multi-step continuous processes. The system will critically enable automated design space generation for flow processes, while also giving users the flexibility to interface with enabling technologies including photochemical and electrochemical synthesis. By combining advanced automation with data-driven experimentation, kinetic modeling, Artificial Intelligence (AI) process modeling and an intuitive yet robust interface, we plan to make flow chemistry process R&D accessible and harmonized within our organization.

Disclosures: All authors are employees of AbbVie and may own AbbVie stock. AbbVie sponsored and funded the study; contributed to the design; participated in the collection, analysis, and interpretation of data, and in writing, reviewing, and approval of the final publication.