Catalent currently has a semi-automated filling machine capable of delivering several hundred vials of product. However, the company is preparing to build an automated vial filling station whenever one of their clients demands it.
“We have the semi-automated machine in place, which is good for early commercialization but, for full commercialization and thousands of patients, it’s not enough,” says Jef Pinxteren, PhD, director of process and analytical development at Catalent.
As well as an automated vial filler, company officials also point out that they will need large-capacity controlled-rate (CR) freezers for cryopreservation. They plan to bridge the lead time between client commission and building the machinery by scaling out their existing semi-automated systems.
“The lead time is due to the building and operation,” says Pinxteren, explaining that automated vial fillers are still the proof-of-concept stage with none in operation, to his knowledge. Large-capacity CR freezers, meantime, remain on the drawing board, he adds.
Companies developing early-stage allogeneic therapies need to approach a contract manufacturer early to discuss fill-and-finish, Pinxteren emphasizes, to avoid delays while equipment is bought and implemented.
“People are developing processes that need 50 to 200 L bioreactors with billions of cells coming out, which is above the vial filling maximum,” he says. However, these companies are too nervous to discuss vial filling before Phase III trials.
“As a CDMO, we’re more proactive, but it’s not something you’d make a large investment in when you’re unsure if the customer request is going to come through,” he continues.
As an example, an automated vial filler requires an investment of 2–3 million euros, he explains, and the lead time for the machine to be built is 12–18 months.