Improving Supply Chain Resiliency through Aseptic Connector Alignment and Standardization

Abstract

Single-use technologies (SUT) for biomanufacturing have been gaining wide adoption over the last ten years. This was even more accelerated during the COVID-19 pandemic when vaccine developers utilized the technology, having priority access to manufacturing capacity and material inventory through Operation Warp Speed. This was a testament to the manufacturing and development efficiencies enabled by SUT compared to traditional stainless-steel manufacturing, but also a bane to the rest of the pharmaceutical industry from a supply chain perspective.

To persist in the short term, Amgen continued their operations through a dedicated task force that collaborated closely with internal plants and external suppliers to anticipate shortages and mitigate them. To build supply resiliency in their single-use assemblies for the long-term, Amgen sought to standardize aseptic connectors, enabling greater collaboration and network transferability of parts within plants that are currently standardized to different connector preferences.

Here we show a detailed assessment of the various aseptic connector options at Amgen, along with a cost-benefit-risk evaluation of standardization, and an implementation plan supported by an external benchmarking of a few of Amgen’s peer companies. Our analyses and recommendations were informed by internal stakeholder interviews, peer company and subject matter expert interviews, supplier outreach, internal data analysis, and a manufacturing associate survey. We evaluated the connectors based on technical design specifications, supply robustness, defect risk, and user experience.

Due to cost constraints to undertake standardization comprehensively all at once, we recommend selecting a single candidate connector for standardization with a phased approach for implementation upon new site builds and technology introduction. This allows Amgen to deploy standardization as part of other value-adding improvements to their operations, such as their new site build in Amgen North Carolina. With introduction of a standard aseptic connector in this new site, over 60% of existing connectors from two other plants are covered by the revision, lowering the barrier for those plants to move to the standard in the future. This approach to evaluating the impact of process component standardization across a network of manufacturing sites is useful for other technology standardization that companies are evaluating.