Pfizer, an American multinational pharmaceutical, and biotechnology corporation, has announced a $120 million investment at its Kalamazoo facility, allowing for U.S.-based production to support its COVID-19 oral treatment, PAXLOVID.
The company states the expansion will create more than 250 high skilled jobs in Kalamazoo by broadening production of active pharmaceutical ingredient (API) and registered starting materials (RSMs) used in the manufacture of nirmatrelvir, a novel main protease (Mpro) inhibitor.
The advancement aids Pfizer’s effort to create more biopharmaceutical manufacturing in the U.S., which boosts the company’s capacity to develop and supply treatments and medicines for U.S. and global patients.
“Pfizer Global Supply has made the impossible possible, making billions of vaccine doses and now millions of treatment courses to help battle the deadly COVID-19 pandemic,” says Albert Bourla, chairman and CEO of Pfizer.
“By increasing production at our Michigan facility, we are both helping patients around the world and expanding important manufacturing innovation to the U.S. This investment builds upon our $5 billion of investments across our manufacturing and distribution portfolio since 2017 to support the ongoing growth of U.S. manufacturing leadership.”
RSMs are the raw materials that are chemically converted into API, the active ingredient in a medicine. A significant amount of manufacturing capacity is needed to produce PAXLOVID. Recently, Pfizer has shipped 12 million courses of PAXLOVID covering 37 countries, including 5 million courses shipped to the U.S., and has made almost 17 million treatment courses total.
The investment happening in stateside API and RSM production for nirmatrelvir will enable Pfizer to extend supply capacity for PAXLOVID as needed to reach global demand. With the investment, Kalamazoo will be among the world’s largest producers of API, with the capability to produce 1,200 metric tons annually.
The company also plans a phase two investment to increase its modular aseptic processing (MAP) sterile injectable pharmaceutical production facility in Kalamazoo. The expansion builds on the original investment of $450 million in phase one for a 400,000-square-foot production facility.
“Pfizer’s Kalamazoo facility has been at the forefront of pharmaceutical manufacturing for more than 135 years through the legacy company Upjohn,” says Mike McDermott, chief global supply officer of Pfizer.
“The Kalamazoo facility uses some of our most innovative manufacturing technology and has been essential in Pfizer’s fight against COVID-19, producing nearly one billion doses of COVID-19 vaccine at the site to date. Through this expansion, we will continue to invest in the next generation of manufacturing and supply chain resilience.”
Pfizer’s EPIC-HR (evaluation of protease inhibition for COVID-19 in high-risk patients) study results showed an 88% reduction in COVID-19-related hospitalization or death from any cause in adults treated with PAXLOVID compared to placebo within five days of symptom onset. Currently, PAXLOVID is approved or authorized for conditional or emergency use in more than 60 countries across the globe to treat high-risk COVID-19 patients.
To learn more about PAXLOVID, click here.
To learn more about Pfizer Global Manufacturing, Supply, and Distribution, click here.