Below is a listing of all sessions the speaker is scheduled to present.
Yang Zhang
Research Assistant
University of Texas, Austin
Thursday, March 27, 2008
Technology Enablers
T-13: Application of PAT in Product Development 10:15AM - 11:15AM (Thursday, March 27, 2008)
The Process Analytical Technology, PAT, initiative encourages innovation in pharmaceutical development, manufacturing, and quality assurance to enhance understanding and control of the manufacturing process. The challenge for many manufactures is to identify how best to address the opportunities that PAT offers. Broadley James, Emerson Process Management, and the University of Texas are working together to examine and quantify the potential to reduce cycle time and out-of-spec product through the use of high fidelity, dynamic simulation and multivariate analytics. The objective of this work is to show that the impact of PAT can be maximized through the integration of these tools during product development (PD). Experiments are being run using a CHO cell line and 7 liter bio-reactors. In this presentation, information will be provided on the capability developed for fidelity process modeling of the mammalian cell cultures. A design of experiments (DOE) is described that minimizes the time and tests required to identify model parameters. Examples will be presented to illustrate how this simulation capability in a virtual plant is being used to find the best approach in stepping process inputs and operating conditions and how the improvements found through simulation are verified through experimental test. Also, information will be presented on innovations in PCA/PLS analytics for fault detection and end point prediction of quality parameters. Details will be provided on work that is being done to verify detection of faults and accuracy of end point prediction of quality parameter. Plans for future work will be presented that include applying this simulation and analytic capability during scale up from 7 liter to 50 liter disposable reactors.
