The Niro division of GEA Process Engineering has supplied three cell disrupters to the UK's National Biomanufacturing Centre (NBC) in Speke, Liverpool.
The NBC gives start-up companies the facilities to trial manufacturing methods and attract investors for new drug production. It is set to become Europe's leading biopharmaceutical design centre with the ability to manufacture a wide variety of novel medicines for early-phase clinical trials.
The Niro cell disrupter units consist of high-pressure homogenisers and associated equipment designed to extract cell material with a very high degree of efficiency.
The first of the Niro-designed skids incorporates a Niro Soavi NS3006H high pressure homogeniser and the second a smaller Panda 1001 2K; both reach pressures of 1500bar with capacities of 20-50 litres/hour and 5-10 litres/hour respectively. Each skid includes the homogeniser, a pre-feed pump and a shell & tube heat exchanger to keep the temperature of the homogenate down, especially when working with heat-sensitive materials.
The third unit, also a Panda 1001 2K, was supplied to the process development suite to ensure continuity throughout the entire process. The two skid-mounted machines are equipped with 'plug and play' CIP/SIP facilities (clean in place/sterilise in place).
The high energy input required for cell disruption to take place requires the use of carefully selected materials to prevent premature wear. Niro Soavi has made full use of ceramics within the equipment and has included its multi-block system to maximise the life of the equipment.
A unique feature is the 'knife edge', type 'R' valve incorporated into all three machines. This valve is designed specifically to achieve the maximum cell disruption from the lowest power input. Niro says that, in trials using E-Coli for example, it is possible to achieve 94% cell disruption with two passes at 1,000 bar using this technology.
The aim of the NBC is to provide appropriate cGMP facilities to develop drugs then mirror the way the finished product will be made when in full production to eliminate difficulties with scale up and minimise the time taken for the validation of the process.
The Niro NS 3006 H cell disruption equipment is used widely in production facilities therefore all processes trialled at the NBC can be easily scaled up for full production. If very high volume is required it is possible to expand the capacity by using the Niro 3018 or 3037 machines, both of which have similar characteristics to the 3006.
