A systematic approach for assessing next generation technologies and solutions in biomanufacturing

Abstract

Amgen is one of the world's leading independent biotechnology companies and competes globally to advance important medicines in a highly competitive marketplace. Biologics manufacturers such as Amgen have traditionally invested in costly, large-scale stainless steel infrastructure to support the production of biologic medication. However, more recently, changes in the economics, such as the need to deploy less-capital intensive biomanufacturing plants faster, and advances in the technology, such as process-intensification (i.e., getting more protein from each cell), have created both incentives and pressures for smaller-scale, single-use, and modular production technologies. These incentives include greater flexibility, shorter timelines for construction / rapid deployment of new facilities, and reduced costs as well as physical and environmental footprint.

To prepare for this changing business environment, Amgen must develop a manufacturing strategy that can enable the production of high quality products with significant reduction in timelines, cost, and reduced impact. To do so, Amgen is investigating a handful of these new production technologies, known as next generation manufacturing technologies, and attempting to understand their applicability in their future manufacturing model. There is a need for a transparent and standard methodology for evaluating and deploying new technologies in the manufacturing network. This study aims to address this issue and enable speed, rigor, and efficiency of decisionmaking through the use of a structured framework for selection and deployment of next generation technologies. Through literature review and engagement with Amgen experts, this study defines a next generation manufacturing technology evaluation framework.

This framework involves a hybrid, multi-attribute set of metrics that are broadly categorized into economic, environmental, and operational assessment areas. The framework is then applied to assess the economic, operational, and environmental implications of deploying single use technologies in drug substance manufacturing as a test of concept. An assessment along the three areas helps to identify that single use technologies, namely single use bags due to their cost and environmental footprint, may not always be the optimum substitute for all existing process technology. Instead, a hybrid approach, mixing new single use technology with existing stainless steel infrastructure, may help to reduce variable cost and carbon footprint of the process.

When the framework and this proposed hybrid approach was at an Amgen site, a potential savings of up to $ 1 M per year was identified as well as the elimination of up to thousands of liters in clean water losses, and up to 400x reduction in the carbon footprint of the process. Lastly, the assessment framework is applied as a management tool in the assessment of next generation drug product filling technology to demonstrate how the framework can be used to enable rapid decision-making related to future manufacturing scenarios.