A Novel, Real Time Adaptive Process Control System for Optimizing Feeding in Bioreactors

A Novel, Real Time Adaptive Process Control System for Optimizing Feeding in Bioreactors

04/17/2018, 4:15 PM - 5:00 PM

Technical Conference Stage 3, Booth 1376, Exhibit Hall

Language:
English

An in-line process monitoring system and method for in-situ, real time monitoring and control of nutrient and carbon source feeding in bioreactors is described. The system responds to the overall metabolic environment of the process under observation and is highly sensitive to any molecular level perturbation in the process media, such as occurs when a biological process is fed nutrients and carbon sources. An automatic, closed loop adaptive feeding protocol that responds to these real time changes in nutrients then maintains proscribed optimum nutrient concentrations. Faster process development cycles, time to clinic, and the promise of better product quality and titer are typical outcomes. The system can actively and independently manage multiple feeds to further optimize bioreactor optimization. The system is applicable to all scales of operation and modalities from process development to commercial production in fed batch, perfusion, and continuous operation. It is compatible with SUBs. This technology is applicable in microbial, fungal, and mammalian cultures. The application of this technology in mammalian cell culture will be described.

Contributors

  • George Barringer

    Speaker

    Director USA

    Stratophase Ltd

Type of Session

  1. Type of Session
    Session

Learning Objectives

  1. Learning Objectives 1. This session will describe how to monitor and control feeding cycle composition and frequency in upstream bioreactors based on measuring and responding to the metabolic activity of the underlying culture. This is automatic and based on demand. This is a new approach to controlling bioreactor feeds. 2. This session will describe how a well established technique (R.I.) that is often a technique of last resort due to its lack of specificity has been redeployed in a new application which has unmet needs - specifically real time, successful application of technologies in bioreactors to automate fully the manufacturing process. In this application the specific unmet need is automating full, accurate, feeding strategies to optimize culture cycle times and production titer. This technology fully demonstrates successful implementation of FDA Process Automation Technology objectives to improve biological manufacturing processes. 3. This technology is scale, medium, vessel, and modality independent. Thus it can be used in any biological production facility to facilitate improved throughput and efficiencies. Examples of applications discussed will inform audience of a methodology to improve throughput and efficiency at any scale and operation in overall upstream late stage process development and manufacturing. The examples discussed in the session will demonstrate that the technology can directly reduce cycle times and increase titer leading to better efficiency, lower cost, and shorter time to market - all of which are current issues in industrial biopharmaceutical manufacturing.

Categories

  1. Track
    Manufacturing Efficiencies & Improvements

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