The event, the first in a planned semi-annual series through the rest of the project, took as its focus activity within Work Package 4 into constructive models for manufacturing processes and product performance. As well as being an opportunity to take stock of progress and to refine approaches to this large work package’s sub-themes covering the key operations which constitute late stage primary and secondary stage pharmaceutical manufacture, the meeting benefited from insightful contributions from guest speakers in the pharmaceutical industry.
Simon Black, Principal Scientist at AstraZeneca offered an intriguing R&D perspective on process development possibilities through an elegant demonstration of the assessment of crystal structures and morphology of complex drug molecules through modelling approaches available to the general user in the Mercury software from CCDC. In challenging the development community to achieve more systematic use of such tools to broaden the considerable benefits, Dr. Black identified the need to design the tools for ease of use on relevant molecules, and for in-house training using relevant examples. Steve Hammond, Director of Process Analytical Support at Pfizer Inc. offered a broad-ranging commercial manufacturing perspective on key challenges and issues in pharmaceutical manufacture, reflecting on drivers and changes over time in technological possibilities, regulatory approach, and cultural attitudes in the industry, as aspects of the landscape within which manufacturing has to operate. Greater availability of the necessary tools and recognition within manufacturing of the need to take ownership of the materials science that underpins performance now mean that a range of challenges and associated opportunities are opening up for problem solving and, potentially, to transform key operations such as crystallisation through intelligent automation.
ADDoPT will be looking to build on the successful format and themes developed at the first Research Event at the next meeting in the series due to be held at Fitzwilliam College Cambridge on 18th and 19th September 2017, where the thinking will shift to ADDoPT systems framework level, exploring interconnectivity across the project and potentially beyond.