San Francisco November 13-18, 2016
The AIChE Annual Meeting is the premier educational forum for chemical engineers interested in innovation and professional growth. Academic and industry experts will cover wide range of topics relevant to cutting-edge research, new technologies, and emerging growth areas in chemical engineering.
APC will present on the topics listed below:
The Development of Integrated Continuous Drug Substance Processes
Tuesday, November 15, 2016: 8:52 AM Continental 4 (Hilton San Francisco Union Square)
As pressure grows on pharmaceutical companies to deliver increasing levels of process performance, reduced capital and manufacturing costs the industry is looking more and more to continuous processing to help tackle some or all of these challenges.
Within this presentation case studies will be presented where unique continuous processing hybrid platforms have been utilised for the development and operation of continuous processes. These processes included heterogeneous and homogenous chemistries, work-up/distillations, crystallization and isolation. Specifically within the case studies presented details will be outlined, via PAT integration, engineering kinetic and statistical models, experimental and lab rig design, required to enable the design, optimisation and operation of these platforms over multiple week long periods. During the presentation the design considerations over CSTRs, PFRs, hybrid or novel reactor design configurations will be presented and how such design selections can impact or tailor the design properties of the intermediates and importantly the final API solid state characteristics.
API Particle Formation: Technological Approaches to Forming Unique API Characteristics
The formation of highly differentiated APIs to enable specific downstream filtration, drying and drug product performance, in terms of flowability, blending, content uniformity and in vitro disintegration and dissolution is becoming an ever important feature in pharmaceutical process design.
Within this presentation the application of technological platforms, such as continuous processing, hybrid batch/continuous wet milling enabled system, will be discussed in detail. A series of case studies will show the work flow and design details associated to engineering and population balance models, reactor design, supersaturation monitoring / control to enable the delivery of highly differentiated API particle characteristics. The interface between the drug substance and drug product will be discussed at length to demonstrate the ability of engineering strategies to enable predictable downstream process performance.
Model Predictive Control: A Process Development Tool for Mammalian Cell Culture Processes
In recent years, there has been a growing necessity to increase the speed, efficacy and information content associated to the development and scale-up of biopharmaceutical processes, particularly given the regulatory authorities current shift in philosophy towards quality-by-design (QbD). This QbD requirement for increased process understanding intensifies the work involved in the earlier phases of the drug-product lifecycle. The benefit, however, is that the increased process knowledge can speed the technical transfer from development into manufacturing, deliver a more optimised, robust process with higher titres and greater reproducibility and aid in troubleshooting and root-cause analysis of deviations during production.
A model predictive control (MPC) technology platform incorporating Raman spectroscopy was developed as a tool to streamline upstream bioprocess development and applied to a fed-batch CHO culture. In this talk, the core elements of the MPC will be discussed, namely the development of the Raman PAT method for the online quantification of cell density, substrate and metabolite concentrations, the process model and the MPC control algorithm.
The application of the MPC to process development will be demonstrated through a case study of its application to a CHO fed-batch culture. The MPC enabled the transition from traditional bolus to a PAT-enabled continuous feeding strategy in order to prevent nutrient depletion and deliver a stable macro-environment for the cells. Overall, application of the glucose set-point control strategy resulted in a 1.5 fold increase in peak viable cell density (VCD) and the integral of the viable cell density (IVC) which is directly related to increased titre.
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For further details on AIChE 2016 schedule, please visit: http://www.aiche.org/conferences/aiche-annual-meeting/2016