open access publication

Article, 2024

KT-Biologics I (KTB1): A dynamic simulation model for continuous biologics manufacturing

Computers & Chemical Engineering, ISSN 0098-1354, 1873-4375, Volume 188, Page 108770, 10.1016/j.compchemeng.2024.108770

Contributors

Boskabadi, Mohammad Reza [1] Ramin, Pedram 0000-0001-7245-072X [1] Kager, Julian 0000-0001-7274-6678 [1] Sin, Gtirkan 0000-0003-0513-4502 [1] Mansouri, Seyed Soheil 0000-0002-0924-4947 (Corresponding author) [1]

Affiliations

  1. [1] Technical University of Denmark
    2. [NORA names: DTU Technical University of Denmark; University; Denmark; Europe, EU; Nordic; OECD]

Abstract

The pharmaceutical industry's shift towards biological therapeutics has led to a transition from conventional batch production to continuous manufacturing. This change highlights the crucial need for effective process monitoring and control strategies to ensure consistent product quality and stability. Open-source benchmark simulation models have become essential tools for refining these processes, offering a platform for testing research hypotheses. This study uses the production of Lovastatin as a case study for continuous biopharmaceutical production. A comprehensive dynamic model covering upstream and downstream components provides an integrated perspective of the production process. The study introduces a basic control system emphasizing realistic sensor and actuator integration to enhance simulation accuracy. It assesses the benchmark through open-loop and closed-loop simulations, offering an in-depth analysis of the KTB1 model's dynamic response and functionality. KTB1 represents a model-driven decision support tool that enables the evaluation of monitoring strategies, process design, process optimization, and control for biomanufacturing.

Keywords

accuracy, actuator, actuator integration, analysis, batch production, benchmarks, biological therapeutics, biologics manufacturing, biomanufacturing, biopharmaceutical products, case study, cases, closed-loop simulation, components, comprehensive dynamic model, continuous manufacturing, control, control strategy, control system, decision support tool, design, downstream components, dynamic model, dynamic response, dynamic simulation model, effective process monitoring, enhance simulation accuracy, evaluation, function, hypothesis, in-depth analysis, industry shifts, integration, lovastatin, manufacturing, model, model dynamic responses, monitoring, monitoring strategies, open-loop, optimization, perspective, platform, process, process design, process monitoring, process optimization, product quality, production, production of lovastatin, production process, quality, research hypotheses, response, sensor, shift, simulation, simulation accuracy, simulation model, stability, strategies, study, support tool, system, test, testing research hypotheses, therapeutics, tools, transition

Funders

  • Novo Nordisk Foundation
  • European Commission

Data Provider: Digital Science

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