MARTIN MAYER, ROLAND MAICHIN
ZETA, Austria

Abstract

The development of pharmaceutical products from development to large-scale industrial production involves numerous planning steps. Time pressure, exacting quality requirements and the costs of investment-intensive plant projects call for new solutions to reduce lead time, prevent the risk of planning errors and ensure compliance with the budget already during the project phase. 

The need for transparency, long-term planning and its end-to-end traceability is high and requires the processing of thousands of different data inputs. The sum of these data provides a digital image of the plant and the process, before construction even starts – this is the digital twin. The digital twin of complex production processes promises reduced complexity and greater benefits to be derived from the planning data.

One digital twin in production, one in development and their “triplet” in maintenance? Solutions that provide the flexibility required in pharmaceutical production will only present themselves when the silo mentality is broken down. This is the approach of the ZETA digitization experts.

Several trends, many of them interrelated, are currently driving change in the pharmaceutical industry: The time-to-market is becoming ever shorter to absorb the high risk involved in drug development and to extend the time for decision-making on investments. Personalized medicine for increasingly specific patient populations benefits small-scale production. Massive competitive pressure challenges the players to outperform others in the respective drug class while at the same time incur as low costs as possible. The consequence of all these developments is an unprecedented level of agility, flexibility and adaptability that we are currently witnessing in the pharmaceutical industry.

The digitization of pharmaceutical production promises to provide the means to meet these challenges. One of these means is the “digital twin”, i.e. a full copy, a ...