Astellas Feasibility Study for Continuous Freeze-drying

Spin-freezing is a novel technology to solve know batch freeze-drying  issues. This technology enables us to reduce processing time as well as easily detect foreign matters. Also, reconstitution time is significantly reduced. Spin-freezing technology can be leveraged to continuous freeze-drying (Continuous FD) for larger production scale. Feasibility study for Continuous FD using RheaLyo™ Mono Freeze-Dryer as single vial unit (SVU) from RheaVita BV was conducted to demonstrate its benefits on the common issues seen in Batch FD.

Lyophilized placebo samples with spiked foreign matters (hairs, fiber, etc.) were prepared using SVU. As a result, the foreign matters were easily detected by visual inspection, because a thin layer was formed along the inner wall and the foreign matters were pushed out onto outer surface of cake. This will be easily detected even by automatic inspection machines.