MaSTherCell will be able to manufacture about 1,000 batches a year through the expansion, helping to feed the high demand for cell therapy production.
The contract development and manufacturing organization (CDMO) unveiled a 600 m2 wing at its site in Gosseles, Belgium, effectively doubling its cell therapy production capacity through five extra clean rooms.
“Each clean room is about 30 m²,” Romain de Rauville, head of Business Development Europe at MaSTherCell, told this publication.
“The capability depends on the process we are working on but the five clean rooms can be used for several hundred batches per year. With a total of 10 clean rooms, we can reach about 1,000 batches per year.”
MaSTherCell, a subsidiary of Orgenesis, did not divulge the size of the investment. De Rauville said the suites will be used for both allogeneic and autologous production, and an increase in staff will be needed in Gosseles.
“We anticipate adding 50 employees by the end of 2019. With a total of 200 employees, we will be sufficiently staffed for our 10 clean rooms, four development labs, and in-house QC labs.”
The need for additional capabilities by both clients and the general market drove the expansion, de Rauville told us.
“In addition, we have clearly used our experience and focus the design on an ‘agile’ facility. The patient enrollment is a really complicated topic for our partners. You simply do not control it.
“Consequently, they need facilities that you can adapt on demand. We have built several features to answer this needs such as the doubling of capabilities on demand and the option to isolate part of the clean room for commercial manufacturing for instance.”
He added the industry acknowledges there are two gaps in the cell therapy manufacturing space, manufacturing capabilities, and quality.
“MaSTherCell is renowned in the market for its quality and we aim to drive the need for manufacturing capabilities down with this new wing. Although we cannot disclose the occupation rate of the new wing, we can certainly confirm that some clean rooms have been already booked by some of our partners a long time ago as they want to secure their long-term supply. It is very important to note that reliable manufacturing capabilities is a key success factor in the industry.”