(497e) Diverse Uses of Latent Variable Methods In Vaccines and Biologics Manufacturing
AIChE Annual Meeting
2011
2011 Annual Meeting
Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Applications of Multivariate Data Analysis In Pharmaceutical Process Development: Traditional and Advanced Multivariate Methods
Wednesday, October 19, 2011 - 2:10pm to 2:35pm
It is generally understood that latent variable multivariate modeling methods have great value-add potential in vaccines and biologics enterprises. What is relatively less-known, however, is the diversity of tasks that these tools can support in such applications. Although the fundamental math and statistics behind these tools are fixed, each of these different tasks require unique considerations with respect to several attributes, including data alignment/integration, data preprocessing and scaling, model validation, computing hardware, and visualization of results.
This paper will use recent case studies to illustrate the various ways that latent variable methods support current vaccines and biologics efforts at Merck, which include QbD initiatives. These case studies will include retrospective analyses of existing operations for troubleshooting, exploratory modeling of processes for continuous improvement efforts, multi-scale models for scale-down model qualification, and consistency monitoring of manufacturing operations.