Facilities

Our cGMP compliant manufacturing facility consists of two independent suites for the separation of microbial and mammalian manufacture. The facility is licensed and inspected by the MHRA.

The manufacturing rooms are all Grade C, except the fill suite which runs at Grade B with the fill room LAFS running at Grade A. The manufacturing suites are operated under differential room pressures.

Mammalian Production Room consists of a general change room, with access to a process room which then gives access to the upstream production room and the downstream production room.

Microbial Production Room consists of a general change room with access to a process room that gives access to a fermentation room and a centrifuge room.

A dedicated change room is accessed via the mammalian production room general change room, this then leads to the fill room.

QC and Development laboratory is located in a separate building to production.

The unit has it's own wash room facilities which include a validated washing machine, oven and autoclave.