the Company has previously reported, the Flaskworks system is specially designed to carry out the key manufacturing processes for DCVax-L products on a closed basis. Developing this system was particularly challenging because the DCVax-L manufacturing process includes the dendritic cells adhering like barnacles to the flasks containing them, and then the mature activated cells being harvested by detaching them without damaging or destroying them. The Company views use of the Flaskworks closed system as key to enabling DCVax-L production to begin taking place in Grade C suites rather than Grade B suites – and the Company views such transition to Grade C suites as central to large scale-up of production.
DCVAXL is the intended commercial route and therefore must be certified to be able for the MAA to be granted. Thats it