The two facilities, which will be done in about 14 months, includes one 115,000 square foot flu vaccine facility equipped with fixed wall clean rooms and single-use equipment, including Sartorius or GE Xcellerex bioreactors with bags, Kalon CEO Andrew Strong told us at the BIO Conference in San Diego.
The vaccine facility can produce up to 50m pandemic vaccine doses within four months via single-use bioreactors, he added. “So we can generate about 45 batches for 50m doses…The yield for GSK’s product is very high – much higher than the cell line just approved by Novartis,” Strong said.
The other facility is about a 45,000-50,000 square foot facility focused on viral vaccines, which require higher containment level clean rooms, Strong said.
Both facilities are being built with cost-share from BARDA (Biomedical Advanced Research and Development Authority), which will contribute about $176m.
As a subcontractor to the Texas A&M University, Kalon is one of three manufacturing facilities awarded a contract from BARDA – the other two are for Emergent Solutions in Maryland, and Novartis in Holly Springs, NC. But Strong noted that the Novartis facility “is a big question mark” right now as “Novartis is looking to get rid of that facility.”
“Once we’re ready, which will be soon, BARDA can issue task orders to our center for up to $100m per year for biomanufacturing and development of clinical trials regarding biodefense treatments,” he said.
Clean Rooms
Many CMOs are challenged because they have fixed-room facilities that tend to be older, and in which air control is the biggest issue, Strong told us.
Use of the mobile clean rooms in the viral vaccine facility “is a completely new way of doing things in biomanufacturing,” Strong said, noting the way the facility can do multiple monoclonal, plasmid DNA, viral and microbial projects that “can be shuffled around based on what’s needed.”
“We can cut the costs by five times by using a facility like this, with mobile clean rooms,” he added.
Kalon Growth
Kalon now has around 100 employees and rapid growth has been driven by work with the MD Anderson Cancer Center, GSK and BARDA.
The company has plans to expand the facility to 115 employees by the end of the year, and to more than 300 employees by 2020.
Employees are being drawn from Lonza, Sanofi Pasteur, Baxter, Novartis -- with “heavy vaccine and virology experience,” Strong said.
Most CMOs (contract manufacturing organizations) use mammalian cell culture with microbial space for therapeutics, but “we’re also doing gene therapy manufacturing for MD Anderson through a plasmid DNA project,” Strong added.
He also noted that Kalon “would like to get more commercial business, as we do not want to be a sole government manufacturer.” The company is looking to focus on cancer and viral-based manufacturing projects, including microbial and insect cell projects.