New manufacturing workers can get acquainted with the equipment and procedures at Pfizer’s upcoming sterile injectables plant without ever setting foot inside.
Armed with a virtual reality wearable like Oculus or Google Glasses, trainees can test their mettle in a virtual rendering of the facility from almost any location, “similar to a surgeon practicing for a complex surgical procedure,” Pfizer’s Kalamazoo site lead, David Breen, said in a recent email interview.
That’s just one of the high-tech offerings Pfizer has lined up for its new Modular Aseptic Processing (MAP) facility in Portage, Michigan, which the company is trumpeting as one of the most “technically advanced” sterile injectables plants in the world. The new kit marks the latest move by Pfizer to upgrade its injectables business, which faced quality problems after its 2015 Hospira buyout.
The new Portage factory will leverage VR training, robotics, and the latest in isolator-based tech, which promises to keep products safe from contamination, Breen said.
The first floor of the 420,000-square-foot “production engine”—about as big as nine football fields—will house a fully self-contained aseptic production module, which Breen says will focus on production of freeze-dry vials. Pfizer will also use the space to tackle active ingredient dispensing, formulation, stopper processing, robotic glass loading, integrated vial filling and more.
Floor one will also come equipped with a range of washing and sterilization equipment, while the basement will house utilities, electric and locker rooms, and the second floor will be used mainly for office and support space, Breen said.
To keep things running smoothly—and cleanly—the MAP facility will use isolator-based high-speed filling tech, which helps guard products against microbial or particulate contamination, Breen said. It will also use high-shear and low-shear mixing, closed manufacturing tanks, disposable single-use technology, direct load and unload lyophilizers, automated stopper processing, and robotic glass loading.
The plant will start by producing the painkiller Dynastat, though it plans to add products and manufacturing capabilities according to demand, Breen said.
As for VR training, the MAP facility and all its major equipment are being designed using 3D software, Breen explained. The designs are then rendered into 3D models that can be enhanced for training purposes.
Within that virtual plant, trainees can view standard operating procedures and other instructions that apply to each piece of equipment, and then practice the tasks they’ll do in the real world.
“Trainers can observe how the trainees are executing their tasks in the virtual environment and provide feedback on their performance,” Breen said. They’ll have to show they’re proficient in the virtual plant before moving on to actual manufacturing runs.
Sterile manufacturing is a tricky business. All drug ingredients, active and otherwise, plus containers and the like are sterilized in separate processes. The sterile components are then assembled in a cleanroom using specialized equipment, Breen said.
On the other end of production, many of those injectables come with stringent, temperature-controlled storage requirements, which has prompted Pfizer to look for ways to limit exposure to normal temperatures during production, Breen said.
As a look at the FDA’s warning letter history shows, those and other manufacturing hurdles can be tough for injectable drugmakers to clear. Pfizer’s only one of many companies to find itself at the receiving end of an FDA citation, and it spent years grappling with regulatory problems it inherited with its $15 billion Hospira deal.
Pfizer sold or shuttered several of Hospira’s troubled factories but continued to confront problems at the company’s site in McPherson, Kansas. That facility received a warning letter in early 2017 for longstanding problems, including complaints of particulates turning up in product vials. The FDA at the time blasted Pfizer for failing to prevent contamination and neglecting to send the agency field alerts about the complaints.
A little over a year later, around the time the FDA and teams from the European Medicines Agency and Health Canada wrapped re-inspections at the plant, Pfizer’s McPherson site lead said the facility had “demonstrated improvement in many areas,” but admitted it was “still on a journey to drive further improvement and meet our commitments to both our regulators and our patients.”
It was too little, too late for the FDA, apparently, which slapped the Kansas facility with a Form 483 in December of 2018, dinging Pfizer on eight observations, seven of which were repeats—with some noted at least twice before.
To fix the problems and upgrade further, Pfizer made “substantial investments to modernize its sterile injectables network, which includes installing new lines and equipment, hiring additional colleagues, and establishing redundant sources of supply, among other initiatives,” a Pfizer spokesman said via email.
And by 2020, Pfizer appeared to turn a page on its sterile injectables business. Last April, CEO Albert Bourla credited remediation and modernized manufacturing with allowing the company to stock 90% of its injectables portfolio. In March 2020, to cover back demand, the company had distributed seven-and-a-half times the typical volume for 30 of its sterile injectable products.
Those investments paid off during the pandemic, too, the spokesman said. “Throughout 2020, and continuing into early 2021, this network has provided significant incremental shipments of sterile injectables medicines to support patient needs associated with the devastating COVID-19 pandemic,” he said.
Pfizer is plugging $450 million into the MAP facility in Portage, which it first unveiled back in 2018. The move came courtesy of Pfizer’s plot to invest around $5 billion in U.S.-based capital projects, which then-CEO Ian Read credited to the enactment of the Tax Cuts and Jobs Act.
Pfizer broke ground at the plant in late March, and it already has expansion plans in the wings. The company will erect shell space for a second, future production module, slated to take up the same amount of space as module 1, Breen said. The facility is expected to create some 450 jobs in Kalamazoo, he added.
by Fraiser Kansteiner
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