Continuous Manufacturing Processes Design, Development, and Control

Continuous Manufacturing Processes Design, Development, and Control

07/15/2020, 2:15 PM - 3:00 PM

Stage 4, Booth 2276, Exhibit Hall
Language:
English
The continuous manufacturing in the pharmaceutical industry for drug substance synthesis and drug product processing are shifting the manufacturing paradigm. The significant impacts have been demonstrated for reducing energy, cost, time, waste, and footprint, but improving quality and consistency in quality, and also enabling new type of reactions (by flow-chemistry) and new paradigm in process control. Process design and system integration (for drug substance and drug product process for small molecules and Biologics) is the critical aspect to deliver a robust process that is efficient, reliable, and easy to control. Such designs and integration should consider possible disturbances, control strategy, mitigation plans for managing quality issues, production flexibility, and economic (Capex and Opex). In continuous manufacturing, the dynamic interactions between different unit operations increases the complexity of the system.

Contributors

  • Nima Yazdanpanah

    Speaker

    Principal

    Procegence

Objective

  1. Objective 1. System integration and design structure study demonstrate the dynamic interactions between different unit operations and increases the complexity of the system. 2. Predictive models can aid process development by estimating the impact of process and equipment parameters, and material attributes (i.e., the model inputs) on product attributes (i.e., the model outputs) thereby providing a quantitative framework for assessing risk and evaluating risk mitigation approaches. 3. Case studies and examples from small molecules and biologics and drug substance and drug products will demonstrate applications, share knowledge, learn from failure, and provide strategies for easing implementation.

Type of Session

  1. Type of Session
    Session

Categories

  1. Track
    Processing/Manufacturing

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