As COVID-19 vaccines and antibody therapeutics are manufactured globally in response to the pandemic, some pharmaceutical companies are seeing high lead times for the large, single-use plastic bags in which vaccines are created.
Bethlehem, Pa.-based biopharmaceutical equipment manufacturer ABEC Inc. has seen demand for bioreactor, fermenter and mixing system containers overflow from suppliers that can't keep up.
"I know a lot of other suppliers out there are really struggling, mainly because they don't have enough bag manufacturing capacity in place to respond to COVID," Brady Cole, vice president of equipment solutions at ABEC, told Plastics News. "We have many customers telling us they're waiting 10-12 months just for bags, and that's just extraordinary."
ABEC worked to fast-track manufacturing the single-use polyethylene disposable containers using the extra capacity it keeps in place for surprise demand shifts, Cole said.
"We always tend to have extra capacity, because we're in a growing industry and we want to be prepared," he said. "We had to make sure we had the resources and supply chain in place to respond very quickly and turn around both the disposables and equipment much faster than our typical design-build cycle."
ABEC's lead times for the bags are about 16-18 weeks, Cole added.
The design and selection of materials used to make disposable containers "is collaborative in order to leverage users existing material qualification and validation efforts," ABEC's website said. "This strategy enables flexibility in component selection across different unit operations to minimize process, quality and supply chain risk."
ABEC also has global, multisite ISO 7 clean rooms that allow for the "short, disposable container lead times and redundancy of supply," it said.
The company's bioreactor bags have volumes up to 6,000 liters working volume, its fermenters have volumes up to 1,000 liters working volume and its liquid mixing systems have up to 7,000 liters working volume, according to its website.
Bioreactor bags are used to cultivate mammalian cells, fermenters cultivate bacterial cells like E.coli, Cole said, while the mixing systems are used for processing fluids. The bags are made with a multilayer polyethylene film, designed specifically for pharmaceutical use, which is cut and welded to form the product, he said.
The company saw a "significant increase" in demand from the vaccine market because of COVID-19, Cole said, but also because pharmaceutical companies had to continue making other biotech drugs.
"When the pandemic started, a lot of existing capacity that was supporting other biological drug making was taken over by COVID," he said. "We saw some customer activity just due to COVID taking over their existing capacity, so they had to build more for their other drugs. … The biotech industry was already growing at more or less a double-digit pace in single-use, and then COVID just added a lot of momentum to both of those markets.
"Year on year, you see a lot of swings in the demand drivers in biotech," Cole said. "We try to be as flexible as we can to take advantage of those opportunities."
COVID-19 vaccines are expected to be a driver of new technologies, he said: "I think their success is going to be a sustained growth driver in the vaccine side of our industry for the next few years.
"It's clear that [other suppliers] didn't have enough assembly capacity to accommodate this blip," Cole added. "Most of them have announced expansions, but that's going to take another year before they come online."
We have many customers telling us they're waiting 10-12 months just for bags, and that's just extraordinary."