The biomanufacturing GMP facility

2. Structure

The GMP facility has an area of 430 m2 and consists mainly of BL2 and BL3 rooms. It consists of two separate wings, one of which is dedicated to the preparation of macromolecules, the other to the preparation of viral vectors. Both wing entrance corridors are accessed through the entrance gowning room and are separated by an airlock in overpressure.

Macromolecule wing:

The entrance corridor of the macromolecule wing gives access to:

	Five individual BL2 rooms for cell fermentation
	Two totally separate purification rooms, with their own in/out lockers and refrigerated purification zones
	a weighing, buffer/media preparation and washing room
	one aseptic filling suite
	one 4°C storage room
	a zone for Working Cell Bank Storage at -150°C (gas phase of liquid nitrogen)
	a storage room at -20°C & -80°C
	the exit from the BL2 rooms is separate from the entrance, using the exit corridor which gives access to a decontamination autoclave and personal ungowning rooms

Viral vectors wing:

The entrance corridor of the viral vectors wing gives access to:

	three BL3 rooms with their individual entrance and exit airlocks for Sas personnel and material
	a room for storage at +4°C, -10°C, -20°C, -150°C and room temperature
	an aseptic filling suite (BL3)
	the exit airlock of each BL3 room gives access to the exit corridor, leading to a decontamination autoclave and personal ungowning rooms

In addition, the facility contains two rooms for the storage of Master Cell Bank and final products in the gas phase of liquid nitrogen (-150°C) outside the clean room area.

Henogen's clean rooms allow the manufacture of clinical or other bioproducts in accordance with cGMP standards..