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According to a market intelligence report by BIS Research entitled “Global Cell and Gene Therapy Market: Analysis and Forecast, 2019–2025,” the global cell and gene therapy market was valued at $1.07 billion in 2018 and is projected to grow to over $8.95 billion by 2025. The study notes that the market is being propelled primarily by the advances in the underlying service market of cell and gene therapy. Other major drivers include the increasing prevalence of cancer and chronic diseases, the rising number of clinical trials
for cell and gene therapy, steady investment and consolidation in the cell and gene
therapy market, and favorable regulatory environment.

Catalent, a contract development and manufacturing organization (CDMO) with a
long history of drug formulation and delivery, has been active in providing biological drug development solutions for nearly two decades. More recently, it has looked at the opportunities in next-generation biological drugs and has leveraged the opportunities offered by the growth of the cell and gene therapy market. Last year Catalent acquired Paragon Bioservices, a leading viral vector development and manufacturing partner
for gene therapies.

“Paragon’s unparalleled expertise in the rapidly growing market of gene therapy manufacturing is a transformative addition to our business that we believe will accelerate our long-term growth. Paragon brings to Catalent a complementary capability that
will fundamentally enhance our biologics business and our end-to-end integrated
biopharmaceutical solutions for customers,” says John Chiminski, Catalent’s Chair and CEO. “Gene therapy has the potential to not only treat, but cure, numerous serious and complex diseases and supports Catalent’s mission to help patients live better, healthier lives.”

Additionally, in a move to further extend its capabilities in the rapidly evolving field
of next-generation biopharmaceuticals, earlier this year Catalent acquired MaSTherCell Global, a technology-focused cell and gene therapy CDMO.

“MaSTherCell extends our leadership position in the biotech industry, complements our leading gene therapy offering, and allows us to deliver comprehensive development, manufacturing, analytical, fill-finish, and clinical supply solutions for our development partners,” continues Chiminski. “Both autologous and allogeneic cell therapies provide important new treatment options, with a rising number expected to gain regulatory approval over the coming years. Catalent is well positioned to combine MaSTherCell’s expert teams and capabilities with our extensive resources and experience in scaling new platforms, and to help MaSTherCell build out its development and commercial manufacturing capabilities.”

MaSTherCell has a 25,000-square-foot facility in Gosselies, Belgium, providing clinical services, and construction is in progress on a dedicated 60,000-square-foot adjacent commercial-scale production and fill-finish facility, which is scheduled to open in the fall of 2021. Its 32,000-square-foot U.S. facility in Houston, Texas, upon completion of validation activities, will focus on development-scale projects.

According to Karen Flynn, President, Biologics, and Chief Commercial Officer, Catalent’s biologics business is also being supported by organic growth as the company builds out capabilities that have been in its network for a longer time.

“Our Bloomington, Indiana site, which offers both drug substance and drug product for biologics, primarily monoclonal antibody manufacturing, supports products that are in development as well as those that are already commercialized. In fact, there have been 22 regulatory approvals so far from work that has been done in Bloomington.

We are continuing to invest in that site and have invested over $100 million to expand our drug product manufacturing with additional vial filling, prefilled syringe filling lines, and secondary packaging.”

Catalent also invested nearly $100 million at its drug substance site in Madison, Wisconsin, where capability and capacity are being added with two additional trains of 2 × 2000-L bioreactors. This facility is focused on mammalian cell culture.

The key strength to Catalent’s success is its people, emphasizes Flynn.“We’ve got many years of experience in development, biomanufacturing, drug product fill-and-finish, and packaging. Our expertise spans from cell line development to product development all the way through to commercial scale. This exciting growth story has been made possible by our talented staff. One of our biggest challenges is to ensure that we’re continuing to grow our talent just as the industry is facing that same challenge,” Flynn says.

She also addresses the question of which particular services offered by Catalent are seeing the greatest growth in demand.

“We’re seeing significant growth and demand across our entire biologics portfolio, including the work that we do for monoclonal antibodies, as well as for the cell and gene therapy businesses. Catalent had originally started with supporting parenteral products focused on the small-molecule space. As a result, we were kind of underexposed to large molecules,” Flynn explains. “But then Catalent made some strategic investments, starting with the acquisition of Cook Pharmica, which is the Bloomington site. We also purchased a site from Bristol-Myers Squibb in Italy, where we’ll be adding biopharmaceutical capabilities to the fold. That site already has fill-and-finish capabilities from a drug product perspective. So, we’ll be targeting the demand for fill-finish for biologics in the European market.”

Flynn pointed out that Catalent is focused on rounding out the capabilities of the company in order to address the significant growth in demand across the biologics portfolio of drugs.
“If you look at the pipeline, although there’s certainly a lot of buzz about cell and gene therapy, there is no shortage of development in the monoclonal space as well,” she says. “We’re adding expertise and building out manufacturing capacities and associated quality systems along with talent because we know it’s going to take a combination of all of those resources in order to really satisfy our customers and the needs that they have in order to introduce their products into the market.”

Flynn notes that Catalent has the good fortune to work with different-sized companies who are looking for integrated options.

“They want to get to the market quickly and with low risk. It’s not trading one for the other. It’s really both. If they are small or virtual companies, they certainly need the expertise that a company like Catalent has to help them through the development cycle and into clinical supply and commercial manufacturing. But large pharma and biotech companies also partner with companies like Catalent in specific circumstances, such as if they need expertise or secondary sources of supply, for risk mitigation purposes,” she explains. “In the last 12 months we introduced an integrated biologics offering that we call the OneBio SuiteSM. This is focused on the challenges of speed, simplicity, and managing risk on behalf of customers. It provides customers with a single solution from cell line development through clinical supply and is intended to make it easier for them to work with us by providing streamlined timelines and documentation, program management across the different capabilities, and improved planning. These kinds of services go along with the actual manufacturing capabilities so that we can provide a well-coordinated solution for them from drug substance to drug product and even including our global clinical supply services that are under the Catalent umbrella.”

Flynn believes big growth opportunities are in the pipeline of drugs in development, many of them targeted to small patient populations.

“Smaller-scale manufacturing is certainly going to be in high demand. We’re pretty well suited to handle this with our current capabilities and also with the additional expansions that we’re planning over the next year or so,” she explains. “We’re also really excited about cell and gene therapies and that’s certainly driven our interest in our recent acquisitions. Catalent is pleased to have this broad portfolio of solutions to help our customers get their important therapies to market.”

 

For more information on Catalent Biologics, visit www.catalent.com/biologics

 

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