MARTIN MAYER1* , SELMA CELIKOVIC2, JAKOB REHRL3
*Corresponding author
1. ZETA GmbH, Werndorf, Austria
2. Research Center Pharmaceutical Engineering GmbH; Institute of Automation and Control, Graz University of Technology, Graz, Austria
3. Department of Information Technologies and Digitalisation, Salzburg University of Applied Sciences, Austria; Research Center Pharmaceutical Engineering GmbH

Abstract

The article focuses on the challenges of the pharmaceutical industry that are closely linked to the production process, covering engineering, scale-up, technology transfer and operations. It covers digital, modeling- and simulation-based approaches to overcome these hurdles. The use of digital platforms allows for the collection and harmonization of vast amounts of data from various sources and consistent data integration. Model-based technologies are key for simulations and many optimization measures. Using models for optimization (e.g.: Model predictive control (MPC)) are up-and-coming methods for improving biopharmaceutical manufacturing systems. It is investigated whether the bioprocess models generated in a QbD/DoE approach can also be used online for operational support.

Introduction
The challenges the pharmaceutical industry is facing are manifold. They include high research and development costs, long development timelines, complex regulatory requirements, supply chain vulnerabilities, an enormous market competition and an increasing scrutiny on drug prices. Leveraging digital strategies such as artificial intelligence, machine learning, data analytics and blockchain technology holds significant promise in addressing many of
these difficulties.
This article focuses on the challenges of the pharmaceutical industry that are closely linked to the production process, covering engineering, scale-up, technology transfer and operations. Digital, modeling- and simulation-based approaches are to provide answers to prominent hurdles in the following areas:

Engineering and equipment design: Selecting and designing equipment that meets the specific requirements of the process and the regulatory standards of the pharma industry is complex. It goes hand in hand with optimizing the layout of the facility, to provide a safe production environment and enable an efficient workflow. ...