From Engineering to Operations: Addressing Pharma Challenges by Digital Approaches

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. The interdependencies of the core process and the utilities are complex, options for future expansions must also be taken into consideration.
Effective technology transfer: Bringing biotechnological production from the laboratory to an industrial scale is an extremely challenging task, as upscaling the process to production scale involves numerous technological challenges and substantial commercial risks. Technology transfer requires a planned approach with the appropriate documentation, data and information covering all aspects of development, production, and quality control, considering the regulatory requirements (1).

Process optimization and quality control: Due to the high complexity of pharmaceutical manufacturing, it is not a simple task to maintain optimal process efficiency and product quality. The availability of data plays a significant role in process optimization.