The biopharmaceutical industry is moving towards continuous manufacturing to enable a smaller manufacturing footprint, improved environmental sustainability, improved control strategy, flexibility to meet changing demand and safer operations. Despite these benefits, the transition from batch to a continuous mode of operation significantly expands the number of parameters that require evaluation for optimal process design and process characterization, which directly translate to the need for a large and resource intensive experimental data set. These resource requirements can be reduced significantly by augmenting empirical design with modeling.

Here we present a ‘Digital Twin for Integrated Continuous Manufacturing of Synthetic Drug Substance’ via systems-based modelling. As a part of this methodology, process characterization was executed to enable mechanistic understanding and modeling of the physical and chemical phenomena and to obtain quality data that are fed into model development. The model components were integrated to form the end-to-end process model, with which in silico studies (sensitivity analysis, uncertainty propagation, etc.) are performed to identify the key process parameters. The systems-based model enables the subsequent development and testing of an advanced process control strategy. The complete digital twin enables identification and evaluation of other requirements and policies related to equipment, facility, automation, and operations. Development of a digital twin for synthetic CM enables us to predict process performance and product quality in a real plant environment.


13 October 2021, 10:00 EST/ 15:00 GMT


45 minutes plus Q&A


Elçin Içten-Gençer, Amgen

Dr. Elçin Içten-Gençer is a Senior Scientist – Team Leader in Drug Product Technologies at Amgen. She is responsible for pre-clinical to commercial process development of synthetic drug products, continuous manufacturing and digitalization. Previously, she was a part of Drug Substance Technologies where she led process development of synthetic and biologic drug substances and technology transfers to manufacturing sites.

Elçin holds a B.S. from Boğaziçi University, Istanbul, Turkey and a Ph.D. from Purdue University, both in Chemical Engineering. She is the author of 15 peer-reviewed publications and speaker of over 30 international conference presentations. She is the recipient of several awards including Amgen Operations Global Innovation Award for her contributions to continuous manufacturing (2019) and American Institute of Chemical Engineers (AIChE) PD2M Excellence in Integrated QbD Award (2020).