A trio of workers in sterile suits wipe down a room full of large metal vats and other equipment.
It could be the start to a small batch of an artisanal beer, but the brews made at this plant in Harmans near BWI Marshall Airport are far more life-altering.
This is a Catalent manufacturing plant, where officials plan to announce a $230 million expansion Tuesday to their “suites,” or lines, where small amounts of the most advanced medical therapies are produced for some of the biggest pharmaceutical companies.
New Jersey-based Catalent is one of the largest so-called contract development and manufacturing organizations. Its specialty plants are normally unknown to consumers but are gaining attention during the coronavirus pandemic because vaccine makers have outsourced production of billions of doses of their products to them.
Catalent makes vaccines too, but this site focuses on cell and gene therapies, a fast-growing field that promises a host of advanced treatments and cures for some of the worst diseases.
“The majority of people benefiting from these therapies are born with their diseases and there is often a limited window when they can use them, maybe 12 months or a couple of years,” said Randy Henrickson, Catalent’s vice president of commercial operations.
“There is a need to get therapies out quickly, but capacity is limited now,” he said.
Catalent has facilities across the globe, and acquired this site in 2019 when it bought Paragon Bioservices Inc., a similar manufacturer, for $1.2 billion. About 900 people already work there, and Catalent expects to bring on 700 more in the next six years.
Catalent operates 10 lines at the BWI site now, and the company already had announced five more to be completed in mid-2022 when officials saw the need for three more lines. The facility also includes a mammoth warehouse and giant ultracold freezers being prepared to store about two weeks of supplies used in the development process.
The total investment from the eight new lines is $360 million. The company is getting some incentives from the state to expand here, though officials couldn’t say immediately how much.
Henrickson said a few clients already are ready to use some of the new production lines, though he wouldn’t identify them. They all have different levels of need, from cell development to drug product manufacturing to fill-and-finish work, which involves putting the products into vials and preparing them for shipment.
Scientists at Catalent also can also do the technical work of modifying cells that become products at the BWI site. That work happens at other company facilities in Baltimore and in Montgomery County.
At the BWI site, the initial cells for cell and gene therapies come frozen in vials, and more cells are grown in flasks and later in 2,000-liter bioreactors, which look a lot like the stainless steel fermenters used in breweries. When the concentration of cells is high enough, the cells are then merged into inactivated viruses, called viral vectors, that act as the delivery device into people.
The therapies are produced in smaller batches, like artisanal beer. The doses are more likely to be a few thousand versus the hundreds of thousands for vaccines.
As more therapies are approved — the U.S. Food and Drug Administration says it’s approved 22 cell and gene therapies — there will be more need for such facilities.
Frost & Sullivan, a research and consulting company, estimates the market for such contract manufacturers is likely to exceed $10 billion by 2026, up from about $1.5 billion in 2019.
The firm said in an analysis last year that “aggressive investments in manufacturing technology and capacity are essential to fully harness the curative potential of the cell and gene therapy segment.”
That could not only increase access to drugs but also cut costs to patients, Frost & Sullivan said. Now, patients and their insurers can face million-dollar price tags on some new therapies.
The firm’s analysis said there were hundreds of potential cell and gene therapies in the pipeline, which is what’s driving demand for manufacturers.
Dr. Ted Dawson, director of the Institute for Cell Engineering at Johns Hopkins Medicine, said the promise of such therapies is huge, treating everything from rare cancers to loss of vision, though many treatments remain many years off.
The most advanced gene therapies use cells altered in a lab that can fix or replace defective genes. They are sent into someone’s body on those inactivated viruses. The virus can no longer make someone sick but understands how to enter human cells, where the treatments work to alleviate symptoms, cure disease or prevent disease from ever developing.
Dawson works directly on cell therapies for Parkinson’s disease and consults for a gene therapy company investigating an HIV treatment. Others are working on treatments for blindness, sickle cell anemia and other genetic disorders.
One expensive treatment already approved is for spinal muscular atrophy, a hereditary disease that causes nerve cells to die. In the most severe type, the disease leads to progressive muscle weakness and atrophy and ultimately death, usually before age 2.
“As more therapies become approved there is going to be a need for more capacity to make them,” Dawson said. “Like with COVID-19 vaccines, it took quite a while to scale up to capacity. If there is some revolutionary gene therapy or cell replacement therapy for a common disorder, one would need to scale up for that.”
He said it’s impossible to say how fast manufacturing capacity will be needed, noting that progress on therapies is often slower than the public wants. Further, the steps to ensure safety in production are critical. Manufacturing sites have to follow extremely strict requirements from the FDA.
Another contract manufacturer, Emergent BioSolutions in Baltimore, offers a cautionary tale. Two separate COVID-19 vaccines were contaminated there and production was temporarily halted by the U.S. Food and Drug Administration.
More common for contract manufacturers are FDA warning letters about less severe lapses. Inspectors visit each time a product is produced and throughout the process. Most warnings involve maintaining sterile environments and bookkeeping. Catalent has had its share of letters at other facilities, including at an Indiana plant last year and a North Carolina one in 2015. Both were resolved.
While new gene therapies may pose different challenges over time, Henrickson said he reminds himself about the patients, often infants and children.
They need a very special brew, and providing it will “come down to discipline and expertise.”