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View Sub-Track: PAT
Thursday, March 27, 2008
T-12: The Price of Excellence: Examining the Value of Investments in PAT 9:00AM - 10:00AM (Thursday, March 27, 2008)
This presentation will discuss the synergistic aspects of combining process analytical technology (PAT) and Lean manufacturing for operational excellence (OpX). A method for estimating the value of achieving excellence in your operations will be described using published case studies and performance benchmark data. Additionally, the cost-benefit tradeoffs of different technology and project management strategies will be explored. Managers considering incorporating PAT, Quality by Design (QbD), or OpX initiative into their operations are encouraged to attend.
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.
Yang Zhang - Research Assistant, University of Texas, Austin
T-14: Achieving Manufacturing Process Excellence with Quality by Design, Design Space Development, Design for Manufacturing and PAT 2:00PM - 3:00PM (Thursday, March 27, 2008)
In the past, unacceptable product batches were prevented from entering the market only by laboratory testing of the finished product – posing risk to the public and wasting both time and money for pharmaceutical manufacturers. In the new regulatory environment, the challenge is to assure the appropriate quality outcome in “real time” by implementing appropriate systems into the process itself, assuring product quality while the batch is being manufactured versus relying on final product testing (RTQA). The increased emphasis on manufacturing process excellence through “Quality by Design” (QbD) requires manufacturers to make larger investments earlier in the product life cycle with the goal of developing a sound scientific basis for a “Control Space” that accommodates a range of defined variability in the commercial process materials and operations and still produces the right product quality outcomes. Manufacturers have the opportunity to develop a “Design Space” that takes into account the need for different Control Spaces to accommodate future changes in the scale, economics or other aspects of the commercial manufacturing process in the later stages of the product life cycle (ICH Q8). This, along with the adoption of QbD and a quality system as described in ICH Q10, will enable pharmaceutical manufacturers to achieve the “Desired State” of manufacturing. To realize the benefits of implementing QbD, it is critical that CPP and CQA be identified and understood during process development, so they can be measured and controlled in real-time during the manufacturing process. This requires a corporate culture of continuous improvement without the need for regulatory intervention to approve changes. It also calls for close collaboration between the process development and manufacturing teams to achieve a sufficient level of Process Understanding prior to regulatory approval of the commercial manufacturing process. And, of course, it requires the deployment of appropriate, enabling technologies. Such technologies provide a single point of on-demand access by multi-disciplinary users to all relevant data in multiple, disparate data sources (in the same environment with analytics) to identify and understand cause-and-effect relationships in process data and easily share results. Process improvement and QbD will become practical realities only when the barriers to easily accessing and working with all the process data together are removed, and the team can spend its time more productively on science-based collaboration. This is the best way to undertake the Design Space Development, Design for Manufacturing and PAT efforts needed to achieve manufacturing process excellence using the principles of QbD.
Speaker:
Justin Neway - Executive Vice President and Chief Science Officer, Aegis Analytical Corporation
T-15: Implementing Process Analytical Technology in a Regulatory-Friendly, Single-Use Biomanufacturing Process 3:15PM - 4:15PM (Thursday, March 27, 2008)
We report successful implementation of new technologies for on-line monitoring and control of cell culture in a disposable, animal origin-free process. Recombinant human antibody was produced by a well-characterized cell line using a chemically-defined, animal origin-free culture medium and disposable, stirred-tank bioreactors. Traditional methods of monitoring process variables were compared.
Cory Card - Regional Technical Support Manager, Thermo Fisher Scientific
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