The process model and simulation system of the integrated manufacturing process are developed and validated with pilot process of a collaborator for solid based drug products. The deterministic process models are supplemented and adjusted with multivariate statistical process models to take process uncertainties into account. With this simulation tool, one can conduct critical tasks including risk assessment, control strategy determination, identification of critical material and process attributes, and eventually understanding relationship between raw material attributes and process parameters on final product qualities. The process models are imbedded in Monte Carlo simulation to determine design space while considering probability of process failure. The design space with failure probability are used for determining optimum operating ranges of the key process parameters while minimizing Out-Of-Specification (OOS) of Critical Quality Attributes (CQA). The simulation tool will provide significant benefits for regulatory sciences.

Public Health Relevance

The process model and simulation system of the integrated manufacturing process are developed for solid based drug products, and validated with pilot process of a collaborator. The deterministic process models are supplemented with statistical process models to take process uncertainties into account. The process models are imbedded in Monte Carlo simulation to determine design space, which are used for optimizing operating ranges of the key process parameters while minimizing Out-Of-Specification (OOS) of Critical Quality Attributes (CQA).

Agency
National Institute of Health (NIH)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01FD005294-01
Application #
8882951
Study Section
Special Emphasis Panel (ZFD1)
Project Start
Project End
Budget Start
Budget End
Support Year
1
Fiscal Year
2014
Total Cost
Indirect Cost
Name
University of Massachusetts Lowell
Department
Type
DUNS #
City
Lowell
State
MA
Country
United States
Zip Code
01854