- Catalent said it will spend $130 million to build five more gene therapy manufacturing suites at its plant in Harmans, Maryland, to meet "a growing customer pipeline and market demand."
- The new suites are targeted for completion in the first half of 2022. By then, the contract manufacturer expects to have a total of 15 gene therapy suites in two buildings, along with cold storage warehousing.
- Located near the Baltimore-Washington airport, the Harmans campus is one of five Catalent gene therapy sites in Maryland. With the new additions, Harmans will have a footprint of about 350,000 feet and include fill/finish and supply chain services among others, Catalent said.
Catalent is riding a boom in demand for both gene therapy and vaccine manufacturing.
The company's most immediate focus in gene therapy is the production of materials for Zolgensma, a spinal muscular atrophy treatment from Novartis. Catalent last month announced that the Food and Drug Administration cleared the Harmans facility for commercial work on the therapy. It's the most expensive treatment ever brought to market, with a price tag of more than $2 million.
While some gene therapy companies have experienced major setbacks in development in the past year, the field overall is still "at the beginning of a steep trajectory of innovation," analysts at Piper Sandler wrote in a report for investors Wednesday. Data due from clinical trials of gene therapies in the next year may also offer a boost, they said.
One of the biggest hurdles in the gene therapy field is the incredible complexity involved in manufacturing. Some companies have opted to outsource some of the production to contract manufacturers such as Catalent, creating a surge in demand and shortages in supply.
Catalent moved to increase its production capabilities by buying Paragon Bioservices for $1.2 billion in 2019 and Masthercell Global for $315 million this year. It's also continued to expand facilities, including a $50 million plan announced last week to install a new high-speed vial filling line at its plant in Bloomington, Indiana.
Meanwhile, the company has become a go-to partner for drugmakers racing to develop a coronavirus vaccine.
The Harmans location will produce the drug substance for an experimental shot being developed by AstraZeneca, under a deal announced last month. Catalent has also signed agreements with Johnson & Johnson and Moderna.