Juncos - Multinational biotechnology company Amgen Manufacturing Limited (AML) will expand and strengthen its operations in Puerto Rico with the construction of a new production line and a power plant that will use natural gas and will be among the largest on the island.

The new manufacturing line will serve to expand the production of the pharmacological agents manufactured by Amgen, including Repatha, which are shipped from the island to patients in some 70 countries on virtually every continent in the world.

During an exclusive tour of one of Amgen's plants—AML 14—Negocios observed the construction of what will be a new syringe formulation and filling plant, a project that Thomas Seewoester, vice president of operations for Amgen in Puerto Rico, expects to be ready by the end of this year or the middle of next year.

"We currently have a couple of projects that, combined, total several hundred million dollars (in investment). In total, there is a considerable amount of active investment in the facility. We are constantly making improvements, whether large or small. I mention two of the most important ones at the moment, (but) probably every year we carry out between 40 and 60 capital projects at this facility," Seewoester told Negocios.

Since 1992, when Amgen began operations in Ciudad del Valenciano, the pharmaceutical company has invested nearly $5 billion in the 1.7 million square feet of built space, the executive said.

A pharmaceutical microcosm in Juncos

Amgen's manufacturing campus in Puerto Rico is the largest and only one with end-to-end production of more than twenty pharmacological agents.

“We very intentionally purchased a fairly large piece of land, with the early vision that this would become something really big, and it has,” said Seewoester, a native of Germany, referring to the multinational's campus, which covers some 200 acres in Juncos.

Amgen's operations in Juncos could be described as a microcosm. 

In addition to the operational heart of the biopharmaceutical company, Amgen has a research and testing laboratory where the quality of manufactured products is confirmed or the reasons why a container or procedure does not meet production and quality expectations are identified so that they can be corrected.

In addition, Amgen's more than 2,000 employees have access to a wide range of support services, from multiple rest and dining areas, a gym, and showers to a medical area where they can request health care and access clinical laboratory services.

The facilities also have sufficient water, electricity, telecommunications, and data infrastructure to continue operating in the midst of the worst disaster, as happened about eight years ago with the onslaught of Hurricane Maria.

Commitment to quality

But Amgen, and especially plants such as AML 14, where drugs are processed to treat conditions such as rheumatoid arthritis and migraine, among others, does not allow just anyone to enter, and those who are authorized to do so cannot access the facility without complying with a rigorous sanitation process.

First of all, no body makeup of any kind is allowed, and those who wear nail polish are required to wear gloves.

The sanitization process includes passing through three different stations designed to eliminate any possible contaminating particles. At each station, visitors must clean the soles of their shoes—which, incidentally, must be closed—and put on two layers of shoe covers, a hair or beard net, and then clothing that covers the entire body. Getting dressed is no easy task, as the suit must not touch the floor.

This process is carried out every day by some 480 associates who work at the AML 14 plant, including professionals with engineering degrees, master's degrees, and doctorates, who keep the operation running 24 hours a day, seven days a week.

Upon entering the plant, one passes through long corridors with immaculate white walls, concave corners—a measure to prevent particle accumulation—and glass windows that allow one to observe the operation: an automated choreography that fills around 8,500 syringes per hour, or some 65 million injectable doses per year.

The three main stages in the production of an injectable therapeutic drug are the manufacture of the active substance; packaging of the finished product, where the active substance in its individual dosage forms is deposited in 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 the language and specific instructions for use of the drug for each country or region.

The filling process is carried out automatically in an encapsulated machine in which there is no human intervention unless there is an incident with the machine.

The inspection and verification process is carried out with human intervention, which allows defective units to be discarded, as well as the documentation process for the processed drug.

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%.

Almost half of the nearly 40 drugs manufactured by Amgen are processed in Puerto Rico. According to sources knowledgeable about tax matters, the biopharmaceutical company tops the list of manufacturers in the pharmaceutical sector that pay the most taxes to the island, particularly after the approval in 2012 of the so-called 4% tax on foreign companies for sales made by their operations in Puerto Rico to their subsidiaries in other parts of the world.

Amgen's product portfolio covers the therapeutic areas of general medicine, oncology, inflammation, and rare diseases, and includes some of the world's best-selling drugs. Amgen produces Enbrel, Repatha, Aranesp, Parsavib, Prolia, Amgevita, Aimovig, Epogen, and Neupogen, among others.

The Puerto Rico operation processes drugs that reach around 70 countries out of the more than 100 countries covered by the biopharmaceutical company's global network.

Last year, Amgen generated $33.4 billion in total revenue, 19% more than in 2023.

Only Repatha, a drug used to lower LDL cholesterol levels in patients at high risk of heart attack or stroke, saw its sales increase by 36% in 2024.

“Every time a plant is built, it represents a major event for the company, an important milestone. The last large plant we built was the AML 14 finished product plant, about eight years ago. At the time, it became one of the most advanced finished product plants in the world, as it was one of the first to incorporate isolator technology,” said Seewoester.

Among other things, the facility is designed to withstand a seismic event.

Including the AML 14 plant, Amgen Puerto Rico has five state-of-the-art biotechnology innovation facilities for the manufacture of drugs and biopharmaceutical products.

AML has a process development plant, a recombinant protein production and purification plant; analytical and quality laboratories; a formulation, filling, and packaging plant, including a power 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 skilled jobs.

AML has a workforce of more than 2,200 regular full-time associates and generates approximately 800 indirect jobs within the biopharmaceutical sector. Ninety-five percent of the associates who make up Amgen's workforce 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 that end, the biopharmaceutical company has begun construction of a power plant that will use liquefied natural gas. This is an energy redundancy plan, as the manufacturer already has emergency power generation, a logistics system that has been successfully tested during hurricanes, earthquakes, and storms, as well as during the string of blackouts and major energy incidents that the island has experienced.

“Since we built this site, even before we had all our installed capacity, we secured two independent high-voltage transmission lines with LUMA Energy and the government: one from the north and one from the south,” said Seewoester.

This 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 sufficient 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. In other words, the plant operates continuously with electricity, and when that fails, historically the diesel generators are activated as a 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, in general, represents a cleaner source of energy,” insisted the vice president of operations.

Construction of the cogeneration plant, using liquefied gas, is expected to be completed in the first quarter of 2026.

Seewoester clarified that the company has no plans to disconnect completely from the electrical grid, “because the amount of electricity we use is too high to replace entirely; it would require a solar installation of enormous proportions.”

Pharmaceutical transformation

Seewoester insisted that the pharmaceutical industry is on the verge of a profound transformation, driven by digital tools that will accelerate everything from discovery to production of new treatments.

“We are facing a revolution in the discovery stage (of molecules),” said the executive. “Many of the tests that were previously done physically in a laboratory now take place virtually, on a computer.”

According to the executive, the use of artificial intelligence and language models will enable massive volumes of data to be processed and analyzed in seconds, drastically shortening research and development cycles and the eventual approval and production of new drugs, not only at Amgen but across the global pharmaceutical sector.