Emerson Exchange 365

As the world’s largest independent biotechnology firm, Amgen has in recent years played an important role in staking out new ground in the world of biopharmaceuticals. At the Emerson Exchange Americas in Denver, Amgen’s Jeff Comstock and Emerson’s Duane North will explain how the pharmaceutical company is taking innovative pharmaceutical manufacturing techniques to a whole new level.

In 2008, Amgen began outlining what would come to be known as its Next Generation Biomanufacturing Program. The goal of the program was to leverage existing best practices with new technology and process improvements to drive efficiencies across the company’s various manufacturing facilities—first at pilot sites, then at full-scale commercial plants around the world.

“The design of our next generation system was intended to standardize as much of the manufacturing process as possible,” Comstock tells us. “Accomplishing this would be a challenge. Essentially, it meant finding ways to align equipment, software, and production strategies across multiple facilities, simplifying what is normally a very complex and time-intensive practice.” 

Instead of specializing in making a fixed set of products, Amgen’s next generation facilities would be able to handle an unlimited number of drugs, each with different recipes and process requirements. Changing over from one product setup to the next would involve switching out software modules that allow recipe-only modifications, instead of the engineering-intensive method of rewriting code for each new application.

A flexible equipment strategy with plug-and-play automation support would replace fixed, hard-piped units on the production floor. Software would be standardized from one facility to the next rather than customized for each plant. And technology transfer from a pilot site to clinical and commercial sites would be streamlined with the help of an integrated manufacturing execution system (MES) for batch management and recipe downloads.

To help realize their vision, Amgen reached out to Emerson, whose automation experts literally moved in with them.  “We shared office space for months at a time during the three years we worked on the project,” says North. “Co-locating our project teams helped foster collaboration and made it easier to make the most of our combined experience from one site to the next as the program progressed.”

The project got off the ground in 2012 at Amgen’s plant in Bothell, Washington, which served as the product development facility. Research then moved to Thousand Oaks, California, where the next generation process was put into use for clinical trials. With the first two stages complete, the company decided to build a full-scale commercial production facility based on the program’s findings in Singapore, which is the company’s first plant of its kind in Asia.

The automation system that Emerson helped put in place is able to accommodate process transfer from the development to the commercial stages with the least amount of software manipulation necessary. A flexible, layered approach was used in designing standardized automation software modules based on Amgen’s best practices in an effort to reduce the costs and complexity of making product changes, while still meeting the operating requirements of all of the company’s facilities.

Comstock says that, to date, Amgen has saved 50 percent on automation services costs by implementing a standardized automation software library, and has reduced test discrepancies by 70 percent.  The schedule for bringing the commercial plant in Singapore online was reduced by 6 months, and the company estimates it has saved more than $1 million on its automation engineering efforts overall.

Along with flexibility, North concludes, the idea of alignment was central to the project’s success. “You don’t often see large companies maintaining alignment from one facility to the next. Usually each site is its own little island. Amgen drove the concept that all of its facilities would be purchasing very similar software and hardware. No single facility could change automation code without making sure other sites were buying in. It’s a novel approach, but one with huge potential.”