(84at) Asset Intensification: Application of Modelling Tools and Methodologies from a Cdmo Perspective

Effective asset utilization is crucial for a Contract Development and Manufacturing Organization (CDMO) to thrive in the pharmaceutical industry. Proper utilization of equipment leads to process and asset intensification, resulting in a range of benefits for both the CDMO and its clients.

From a client's perspective, good asset utilization leads to improved product quality, increased reliability, and reduced costs. This is critical for the success of their pharmaceutical products, as consistent, high-quality products are necessary to meet regulatory requirements and customer . For the CDMO, effective asset utilization leads to increased productivity, reduced maintenance costs, and improved resource utilization that releases manufacturing time that can be used to accommodate new business. This translates into a more efficient, flexible and profitable company, as well as a stronger reputation in the industry.

To achieve asset intensification, CDMOs can employ various methodologies, depending on the level of abstraction of the problem which is being aimed for. For example, in a manufacturing process, can be used to optimize the process parameters to achieve a desired product quality and can also be used to predict the behavior of the equipment under different operating conditions at different scales. On the other hand, if one would like to optimize the asset’s availability for production, one area to focus on is the changeover (or change-of-line, COL) planning and how to best address the critical resources (e.g., team members and cleaning stations availability) using a modeling framework (e.g. system dynamics or agent based modeling) in order to minimize the COL duration. This last approach can target different levels of abstraction such as a single equipment train , multiple teams and shared cleaning stations.

In this presentation, we will present models and methodologies that are used to cover different levels of abstraction:

• Shop floor level: optimization of the change-of-line of a single asset line with respect to team member allocation and number of cleaning stations
• Building level: optimization of multiple assets with different number of batches and cleaning schedules, shared team members and cleaning stations
• Company level: Design of future capacity taking into consideration projections of next 5 years business needs. The design will encompass not only main assets, but also auxiliary equipment and human resources needs.