Contact Us   |   Print Page   |   Sign In   |   Join
News and Press: Member Organization News

Inside Pfizer's "unprecedented" race in Michigan to Produce COVID-19 Vaccine by Fall

Friday, June 5, 2020   (0 Comments)
Posted by: Alisha Brown
Share |
  • Pfizer's Kalamazoo plant preparing to produce COVID-19 vaccine
  • Trial manufacturing, packaging runs to begin in 3rd quarter
  • Vaccine project known as "Project Lightspeed" within pharmaceutical giant
  • Pfizer Inc. has sequestered a team of nearly 75 scientists and engineers at its Kalamazoo facility to design and build a manufacturing line to produce a vaccine for COVID-19 as soon as the fourth quarter — a huge investment to make a product that has yet to be proven to work.

    In the midst of the coronavirus pandemic, the team of Pfizer employees and contractors is working seven days a week to modify existing production lines and facilities at its 1,300-acre manufacturing campus in Kalamazoo to produce a vaccine, a company executive told Crain's.

    "This is unprecedented for us," said Chaz Calitri, vice president of operations for injectables and Pfizer's interim site lead in Kalamazoo. "The project is called Lightspeed — it's called that for a reason."

    The Pfizer (NYSE: PFE) team in Kalamazoo team intends to begin early engineering runs in the third quarter to test its equipment for formulating, filling and packaging a COVID-19 potential vaccine in what could be tens of millions of units eventually produced in Kalamazoo, Calitri said.

    "This is kind of a novel process because there are no mRNA vaccines on the market today," Calitri said, referring to disease-specific antigens.

    Calitri said the manufacturing preparation work is being compressed into a tight timeline while the company's scientists conduct the first clinical trials in the U.S. in partnership with the German pharmaceutical firm BioNTech SE (Nasdaq: BNTX).

    "By Q3, we want to be able to prove we can formulate it and fill it and package it in our facility," Calitri told Crain's. "And then in Q4 we want to begin actual manufacturing for commercial use."

     
    Calitri
     

    The aggressive timeline hinges on the success of the trial testing and approval from the U.S. Food & Drug Administration, Calitri said.

    "The goal is to scale that as fast as possible," he said. "And again, that will depend upon the outcome of the clinical trials as well."

    The stakes for Pfizer and other pharmaceutical companies to develop and bring a COVID-19 vaccine are high, given the more than 270,000 global deaths from the virus and the Depression-level unemployment the pandemic has created in the U.S.

    "We can't resume normal life until we have a vaccine," Michigan Gov. Gretchen Whitmer said last week.

    Those high stakes are not lost on Pfizer's top executive in southwest Michigan.

    "It's very exciting for us," Calitri said. "I mean, as an engineer, I can tell you these are the kind of dream projects you want to be on."

    The team in Kalamazoo is "dedicated to this, working around the clock so that we can get this vaccine quickly into manufacturing," Calitri added.

    Pfizer's first U.S. clinical trials are being conducted at New York University's Grossman School of Medicine and the University of Maryland School of Medicine.

    Additional clinical trial tests on patients through the BNT162 vaccine program are planned to begin soon at the University of Rochester Medical Center/Rochester Regional Health in New York and the Cincinnati Children's Hospital Medical Center, according to a Pfizer news release.

    Pfizer announced last week that its facilities in Kalamazoo, Andover, Mass., and Chesterfield, Mo., would eventually manufacture the COVID-19 vaccine.

    Pfizer's Kalamazoo facility employees 3,000 and produces an array of sterile injectables, liquid and semi-solids medicines such as antibiotics, antifungals and steroids, as well as oncology and anemia treatments.

    Because the pharmaceutical industry is classified an essential business, Pfizer's workforce in Southwest Michigan has not experienced any interruptions of work.

    About 40 percent of the 3,000 employees in Kalamazoo are working remotely from home; the rest are reporting to work at the campus each day, Calitri said.

    Like other businesses, Pfizer has changed workplace procedures to try to prevent any employee from being exposed to COVID-19 on the job.

    Pfizer employees have to pass a health screening to enter the 1,300-acre complex and then are more spread out and limiting their movements around the facility, Calitri said.

    "There's been a significant amount of change," he said. "... We've been very fortunate that we haven't had to stop or slow down any of our manufacturing spaces."


    Creating Value
    by delivering business-critical resources & bottom line savings
    Building Networks
    by connecting Michigan's bio-industry one member at a time
    Growing Talent
    by creating opportunities that develop people & build organizations
    Membership Software Powered by YourMembership  ::  Legal