Emergent Biosolutions has set out to capture a share of the expanding viral vector and gene therapy sector.

The US countermeasures developer said it will spend $75 million to add viral vector and gene therapy manufacturing capacity at a facility in Canton, Massachusetts.

At present the plant – which was acquired from Sanofi in 2017 – produces drug substance for live viral vaccines, including Emergent’s smallpox jab ACAM2000.

Image: iStock/marchmeena29

Emergent said the investment will establish a multi-suite production operation with 1,000 L of manufacturing capacity.

Syed T. Husain, SVP & head of CDMO Business Unit at Emergent BioSolutions, told us there are significant opportunities in the gene therapy sector.

“There is an unmet need in this area. We are seeing long wait times for customers in this space. Emergent has foundational expertise in live viral development and manufacturing, among other competencies, and we are building upon this capability to help produce these therapies and get them to patients.”

He added, “We are in discussions with interested customers, we would be able to initiate development services in 2022, paving the way for manufacturing in 2023 as the new facility comes online.”

The plan is that the Canton facility will make drug substance for viral vector gene therapies, working alongside Emergent’s development services site in Gaithersburg and its manufacturing plant in Rockville, Maryland.

CDMO expansion

Emergent spoke about the expansion of its CDMO business during its Q1 conference call in May, predicting that the division would make a greater revenue contribution than forecast.

CFO Rick Lindahl told analysts “We now expect a greater revenue contribution from CDMO than previously thought… we currently see 2020 CDMO full-year revenue in a range of $125 million to $145 million, representing 55% to 80% growth as compared to 2019.”

He added “We continue to make progress on our strategic and financial objectives, including the expansion of the CDMO services businesses and its contribution to the overall business.”

Gene therapy

The gene therapy sector is expected to grow significantly over the next few years.

According to Allied Market Research the gene therapy market, which was valued at $393 million in 2018, is estimated to reach $6.2 billion by 2026, a CAGR of 34.8%.

This take is shared by analysts at Capstoneheadwaters who wrote that pharma interest in gene therapies will increase demand for CDMOs with production capacity.

The authors said, “The increasing volume of gene therapy drugs under development will require greater manufacturing capacity and, in turn, greater utilization of CDMO capacity.

“CDMOs may be able to increase penetration of their outsourced manufacturing services by providing services at the commercial stage in addition to the earlier stages of preclinical development and clinical trials.

They added, “We see the injection of new capital into both gene therapy drug developers and CDMOs focused on gene therapy manufacturing as a positive industry dynamic.”