Predictive Scale-Up/Scale-Down for Production of Pharmaceuticals and Biopharmaceuticals II
AIChE Annual Meeting
2022 Annual Meeting
Pharmaceutical Discovery, Development and Manufacturing Forum
Phoenix Convention Center
Monday, November 14, 2022 - 8:00am to 10:30am
Scale-up/scale-down is essential in the process development and production in pharmaceuticals and biopharmaceuticals industry. Successful scale-up/scale-down of a process requires understanding of key relevant driving forces for reactions and physical transformations, as well as mass and heat transport phenomena. Application of process simulation/modeling tools (CFD, Dynochem, gPROMS, and etc.) can greatly benefit the process understanding in terms of kinetics/thermodynamics and facilitates establishment of scale-up/scale-down strategies. While, operational issues at scale, such as out-of-specification investigation, new impurity, homogeneity issues, new equipment selection, etc. require a systematic scale-down approach to lab-scale to better understand the commercial scale environment and develop solutions. These challenges are found in both batch and continuous processes for the chemical and biological manufacturing of drug substance and drug product. Contributions that cover theoretical approaches to and/or demonstrated implementation of scale-up/scale-down analysis for drug substance of small molecules, antibody-drug conjugates, or biological products are encouraged for submission to be considered for oral presentation.
Paper abstracts are public but to access Extended Abstracts, you must first purchase the conference proceedings.
Do you already own this?
Log In for instructions on accessing this content.
|AIChE Emeritus Members||$105.00|
|AIChE Graduate Student Members||Free|
|AIChE Undergraduate Student Members||Free|