(74b) Positioning for a Sustainable Future – Continuous Processing, Automation and Predictive Modeling for Efficient Biopharmaceutical Process Development and Manufacturing

Authors: 
Bordawekar, S., AbbVie Inc.
The focus on development of new modalities for advanced therapies and challenges with complex drug candidates has driven adoption of novel concepts and technologies in pharmaceutical development and manufacturing. Industry is focusing more on flexible design concepts involving smaller footprints, shorter cycle times, high degree of automation, digitalization, and improved process control. Enabling technologies such as continuous processing, high throughput experimentation and predictive modeling through first-principles, as well as machine learning can expedite process development, scale-up and technology transfer while ensuring enhanced process efficiency and delivering quality products. This presentation will share AbbVie’s experiences in integrating these technologies into process development and manufacturing facilities and discuss the challenges and opportunities associated with our approaches.

*Shailendra Bordawekar is an employee 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.