This article originally appeared in El Nuevo Día.
Juncos – The biotechnology multinational Amgen Manufacturing Limited (AML) will expand and strengthen its operations in Puerto Rico with the construction of a new production line and a natural gas-powered generating plant that will be among the largest on the island.
The new manufacturing line will serve to expand production of Amgen’s pharmaceutical agents, including Enbrel and Repatha, which are delivered to patients in some 70 countries on virtually every continent.
During an exclusive tour of one of Amgen’s plants—AML 14—Business observed the construction of what will be a new syringe formulation and filling plant, a project that Thomas Seewoester, vice president of Amgen Operations in Puerto Rico, expects to be completed by the end of this year or the middle of next year.
“We currently have a couple of projects that, combined, add up to several hundred million dollars (in investment). In total, there’s considerable investment active at the site. We are constantly making improvements, both large and small. I will mention two of the most significant ones right now, but we probably carry out between 40 and 60 capital projects at this facility each year,” Seewoester told Negocios.
Since 1992, when Amgen began operations in the city of Valenciano, the pharmaceutical company has invested nearly $5 billion in the 1.7 million square feet of built-up area, the executive said.
A pharmaceutical microworld in Juncos
Amgen’s manufacturing campus in Puerto Rico is the largest and the only one with complete end-to-end production of over twenty pharmacological agents.
“We very intentionally bought a fairly large piece of land, with the vision from early on that this would become something really big, and that’s what it’s been,” said Seewoester, a native of Germany, referring to the multinational’s campus, which covers some 223 acres in Juncos.
Amgen’s operations in Juncos could be described as a microcosm.
In addition to the operational core of the biopharmaceutical company, Amgen has a research and defect testing laboratory, where the quality of manufactured products is confirmed or the reasons why a package or process fails to meet production and quality expectations are identified so that they can be corrected.
Likewise, Amgen’s more than two thousand employees have access to a variety of amenities, from multiple break and dining areas, a gym, and showers to a medical area where they can request healthcare and access clinical laboratory services.
The facilities also have sufficient infrastructure support for water, electricity, telecommunications, and data connections to continue operating in the midst of the worst disaster, as occurred eight years ago with Hurricane Maria.
Zeal for quality
But not everyone can enter Amgen, and especially plants like AML 14, where drugs are processed to treat conditions like rheumatoid arthritis or migraines, among others, and those authorized to do so cannot enter the facility without complying with a rigorous sanitation process.
For starters, no body makeup is allowed, and those using nail polish are required to wear gloves.
The sanitization process includes passing through three different stations designed to eliminate any potential contaminant particles. At each station, visitors must clean the soles of their shoes—which must be closed, by the way—and put on two layers of shoe covers, a hairnet or beard cover, and then a full-body garment. Getting dressed is no easy task, as the garment must not touch the floor.
This process is carried out daily by approximately 480 associates working at the AML 14 plant, including professionals with engineering, master’s, and doctoral degrees, who keep the operation running 24 hours a day, seven days a week.
Upon entering the plant, you walk through long, immaculately white corridors with concave corners—a measure to prevent the accumulation of particles—and glass windows that allow you to observe the operation; an automated choreography that fills around 8,500 syringes per hour, or about 65 million injectable doses per year.
The three main stages in the production of an injectable therapeutic drug are the preparation of the active ingredient; packaging of the finished product, where the active ingredient in its individual dosage forms is deposited into the injectable device; and the third stage is packaging, a process that includes placing the primary container in boxes for final packaging and labeling, including language and country- or region-specific instructions for use.
The filling process is carried out automatically in encapsulated equipment where human intervention is not required unless there is an incident with the machine.
The inspection and verification process is performed with human intervention, allowing defective units to be discarded, as well as the documentation process for the processed medication.
Puerto Rico’s contribution to Amgen’s formula
With the construction of the fourth syringe line, with an estimated investment of $150 million, the production volume of Amgen’s plant on the island will increase by 35% .
Nearly half of the approximately 40 medications manufactured by Amgen are processed in Puerto Rico. According to sources familiar with tax matters, the biopharmaceutical company leads the list of pharmaceutical manufacturers that pay the most taxes to the island, particularly following the approval—in 2012—of the so-called 4% tax levied on foreign companies on sales made by its operations in Puerto Rico to its subsidiaries in other parts of the world.
Amgen’s product portfolio covers the therapeutic areas of general medicine, oncology, inflammation, and rare diseases, and also includes the world’s best-selling medicines. Amgen produces Enbrel, Repatha, Aranesp, Parsavib, Prolia, Amgevita, Aimovig, Epogen, and Neupogen, among others.
The Puerto Rico operation processes 70% of Amgen’s production volume, reaching approximately 70 countries out of the more than 100 countries that comprise the biopharmaceutical company’s global network.
Last year, Amgen generated $33.4 billion in total revenue, up 19% from 2023.
Repatha alone, a drug used to lower LDL cholesterol levels in patients at high risk of heart attack or stroke, saw sales increase by 36% in 2024.
“Every time a plant is built, it represents a major event for the company, a significant milestone. The last major plant we built was the AML 14 finished product plant, about eight years ago. At the time, it was one of the most advanced finished product plants in the world, as it was one of the first to incorporate insulator technology,” said Seewoester.
Among other things, the facility is prepared to withstand a seismic event.
Including the AML 14 plant, Amgen Puerto Rico has five state-of-the-art biotechnology innovation facilities for the manufacturing of medicines and biopharmaceutical products.
AML has a process development facility, a recombinant protein production and purification facility; analytical and quality laboratories; a formulation, filling, and packaging facility, including an energy plant (CoGen); a water treatment plant; and administrative and training facilities.
These high-profile buildings within the biomanufacturing industry will be joined by approximately 18,500 square feet of manufacturing space and approximately 120 specialized jobs.
AML has a workforce of more than 2,200 full-time associates and generates approximately 800 indirect jobs within the biopharmaceutical sector. 95% of Amgen’s associates are Puerto Rican.
Strengths that have become lessons
In addition to expanding its operations, Amgen seeks to ensure the uninterrupted continuity of its processes in the face of the electricity crisis facing Puerto Rico. To this end, the biopharmaceutical company has launched the construction of a generating plant that will use liquefied natural gas. This is an energy redundancy plan, as the manufacturer already has emergency generation, a logistics that has been successfully tested amid hurricanes, earthquakes, and storms, as well as in the string of blackouts and major energy incidents that the island has experienced.
“Since we built this site, even before we had our full capacity installed, we secured two independent high-voltage transmission lines with LUMA Energy and the government: one from the north and one from the south,” Seewoester said.
That vision, embodied in a contingency plan for major events, enabled Amgen to resume operations in record time after Hurricane Maria in 2017. Among other things, the biopharmaceutical company has 16 generators and enough diesel storage to operate continuously for 10 to 11 days without interruption.
“The important thing is that we only need one of those lines to operate the site. That is, the plant runs continuously on electricity, and when the power fails, diesel generators historically kick in as backup,” Seewoester explained.
Only large hospitals, such as Ashford Hospital, have a similar electrical infrastructure on the island, the executive said.
The experience gained in Puerto Rico in dealing with major disasters has been replicated in other Amgen operations, and vice versa, Seewoester said.
“Liquefied natural gas offers us a cleaner alternative. It adds additional capacity to what we already have with diesel and, overall, represents a cleaner source of energy,” the Vice President of Operations insisted
Construction of the cogeneration plant, using liquefied natural gas, is expected to be completed in the first quarter of 2026.
Seewoester clarified that the company has no plans to completely disconnect from the electrical grid, “because the amount of electricity we use is very high; to completely replace it would require a massive solar installation.”
Pharmaceutical transformation
Seewoester insisted that the pharmaceutical industry is on the verge of a profound transformation, driven by digital tools that will accelerate the process of discovery and production of new treatments.
“We are facing a revolution in the discovery stage (of molecules),” the executive stated. “Many of the tests that were previously performed physically in a laboratory now occur virtually, on a computer.”
According to the executive, the use of artificial intelligence and language models will enable the processing and analysis of massive volumes of data in seconds, dramatically shortening the research and development cycles, as well as the approval and production of new drugs, not only at Amgen but across the entire pharmaceutical sector globally.