Pfizer brings aseptic Michigan site into COVID-19 vaccine production mix

by Thursday, May 7, 2020  2:36 pm

Pfizer’s sterile injectable facility in Portage, Kalamazoo is among the sites being leveraged to support clinical trials of a COVID-19 vaccine being developed with BioNTech.

In April, Pfizer teamed up with German firm BioNTech on its messenger (RNA) vaccine program against COVID-19, caused by the novel coronavirus (SARS-CoV-2). A month on, and the candidate BNT162 has entered the clinic with the first US patients being dosed in a Phase I/II trial this week.

To support rapid development, Pfizer has stressed the need to make millions of doses at risk of the potential vaccine by the end of 2020. CEO Albert Bourla told stakeholders during the firm’s recent Q1 results call that he “expect[s] that we will have in the last quarter of this year, millions of doses basically ready. And then, for ‘21, we could ramp up to hundreds of millions of doses available.”

Image: iStock/benkrut

While manufacturing ramp-up plans are being developed at BioNTechs’ mRNA production sites in Mainz and Idar-Oberstein, Germany, Pfizer is looking to leverage its extensive US production network to support the project.

And according to local Michigan news sites, Pfizer is planning its initial manufacturing of the vaccine at its facility in Portage, Kalamazoo County site.

“COVID-19 has shown how vulnerable our country is when it comes to supply chain and much of the lifesaving materials we need are manufactured out of the country,” Michigan Governor Gretchen Whitmer said in a statement Tuesday. “That’s why we are so proud that one of the largest pharmaceutical manufacturing facilities in the world is the Pfizer site right here in Kalamazoo, Michigan.”

The Portage site is a supplier of sterile injectable, liquids and semi-solid medicines, for Pfizer and produces more than 150 products. The site has been subject to numerous investments by Pfizer over the past few years, with a $465 million expansion in 2018 to add a 400,000-square-foot Modular Aseptic Processing (MAP) facility.

Pfizer also has production plants in Massachusetts, Missouri, and Puurs in Belgium, which have all been identified as manufacturing centers for COVID-19 vaccine production.

BNT162 is one of several mRNA COVID-19 vaccines progressing through the clinic. Others include candidates being developed by Sanofi, Moderna Therapeutics, Arcturus Therapeutics, and CureVac.