Digitally Transforming Pharmaceutical Process Development and Manufacturing: Enabling Technologies for a Sustainable Future

The focus on accelerated development of new modalities for advanced therapies and challenges with complex drug candidates has driven the adoption of novel concepts and technologies in pharmaceutical development and manufacturing. The active substances have become more structurally complex and R&D timelines continue to be compressed, the technologies necessary to provide safe, robust and economical access to these molecules need to keep pace. Enabling technologies such as automation and associated information management systems are increasingly being used in the development and manufacturing of therapeutics across the pharmaceutical industry to collect, analyze, and interpret an immense amount of advantageous process data that would otherwise be inaccessible. This combination provides many additional benefits, such as enabling processes, and the ability to safely handle highly reactive, unstable, and toxic reagents. All these aspects help to minimize the time and cost associated with the development and manufacture of drugs and bring medicines to patients more effectively. The importance of such concepts has become even more evident in the recent Covid-19 pandemic crisis, different organizations are actively thinking of implementing these paradigms to their benefit. In order to fully leverage and integrate the larger organization, end-to-end automation and information management strategy and vision is necessary where there is a seamless workflow for automated route screening to optimization and scale-up of the robust process is established. This presentation will share AbbVie’s strategy and experiences in integrating such end-to-end technologies into process development and manufacturing facilities and discuss the challenges and opportunities associated with our approaches.

Presented by Moiz Diwan, Ph.D. Process Research and Development, AbbVie Inc., North Chicago, IL

Moiz Diwan is a director within the Process Research and Development organization at AbbVie. Moiz has led early to late-stage pharmaceutical development teams involving drug substance control strategy development, establishing a global supply chain, process tech-transfer and scale-up, and authored global regulatory filings for 1^st Gen. HCV Viekira and HCV Next Gen. Mavyret drugs. Presently, Moiz is leading Center of Excellence, a cross functional team of chemists, engineers and PAT scientists focusing on fundamentals‐driven process development through application of enabling technologies, data rich experimentation, and predictive modeling. This center has supported commercial process development and regulatory submissions for 6 commercial drugs and >50 clinical assets in last 5 years. Moiz also built from the ground-up FAST – Flow and Automation Strategy Team at AbbVie. FAST is a multi-disciplinary team of scientists and engineers from 13+ AbbVie sites across Discovery, Development, and Operations Manufacturing organization to efficiently share capabilities and resources, facilitate collaboration and provide strategic advancement on lab automation, plant automation, and information management to maximize the impact. Moiz is passionate about people, building and sustaining high-performance organizations, continuous learning, and translating science and innovation into products that make a difference in human health.

Moiz has captured his scientific contribution in over 60 journal publications, patents, book chapters, invited seminars and conference presentations. Moiz is a board member of the AIChE PD2M committee, board member of AIChE Management Division, an editorial advisory board for CEP magazine and board member of Purdue Chemical Engineering Industrial Advisory Committee. Moiz was Programming chair for the PD2M division of the 2020 AIChE Annual Meeting. Moiz was awarded the 2021 AIChE Young Leader award for outstanding leadership and impact on the practice of Chemical Engineering. At AbbVie, Moiz is a recipient of the President Award, AbbVie Volwiler Scientific Society Outstanding Team Award and multiple Excellence Awards for global regulatory submissions and the Launch of HCV Viekira Pak and NXT Gen. Mavyret. Moiz completed his M.S. and PhD degree from Purdue University in Chemical engineering and bachelor’s degree from the Indian Institute of Technology in Chemical Engineering.