It's Copy/Paste In Fleet Management Manufacturing

By Katie Anderson, Chief Editor, Pharmaceutical Online

Copy and paste may be frowned upon in most work tasks, but not in the case of “fleet management.”  In the past few years, Roche and Novo Nordisk collaborated to introduce this concept of applying the copy/paste action to standardized, decentralized facilities. This collaboration was discussed in a presentation by Toby Grouthouse (Novo), Line Lundsberg-Nielsen (NNE), and Alvin Yang (Roche) at the 2025 ISPE Annual Meeting & Expo.

The fleet management concept was developed to answer the needs to reach more patients and answer the demand for advanced products. It also helps get new products and formats on the market and future-proofs facilities.

The Fleet Management system includes standardized facilities with equivalent manufacturing systems that are copied and pasted across a global network and connected digitally. At Roche, this concept was used to standardize the single-use, small volume drug substance facilities, as discussed by Alvin Yang, the drug substance global MSAT technology and network standards steward for Roche. The company replicated its South San Francisco Clinical Supply Center to create a higher commercial manufacturing gat its Oceanside Single Use Technology Facility. The replication shortened the design phase and avoided critical paths.

At Novo Nordisk, a fill/finish manufacturing network was created as a fleet to respond to patient demands. This fleet concept starts with designing one and then building many. For example, a formulation fleet, packaging line fleet, assembly line fleet, inspection line fleet and filling line fleet are designed and then replicated across sites, as described by Lundsberg-Nielsen. These systems are then networked and operated by a central PQS. The central PQS doesn’t necessarily have to physically be at headquarters and can be at a site as long as the owner of the fleet. This PQS includes a process performance and quality monitoring system, a deviation system, a CAPA system and a change management system, according to Lundsberg-Nielsen.

At the top is a strategic level, which defines strategy and has oversight for implementation. There is then the operation level that creates and maintains the fleet, in addition to approving documentation. Finally, there is the local site, where the equipment and parts are managed and change is managed.

A key element in fleet management is collaboration, so that sites can share and learn from each other. This can be done digitally, and tracking can happen digitally as well. An oversight framework must be developed for quality control.

So, what are the benefits of incorporating a fleet management approach to decentralized manufacturing? For one, the facilities and lines are established both faster and cheaper. All of the equipment doesn’t need to be individually qualified. Each of the facilities do not need to be qualified. You need only to qualify the first and replicate that. Operationally, documentation is reduced and personnel time is reduced. Change management is also streamlined. Changes to fleet systems require collaboration, connection with network partners, quick production support, deployment efficiencies and tracking. The teams have to work together when a change is proposed, and it has to be agreed upon by the entire group and the standard owner. Because it requires more effort to make changes, smaller changes may not always be implemented.

However, this collaboration allows for better sharing of information if an issue arises. Another facility may be able to help with an issue.

Establishing a fleet management system requires planning and collaboration, but at the end of the day, it can bring drugs to patients faster. As many have allocated money for new sites for expanded manufacturing, now is the perfect time to consider this concept.