Niro has supplied three cell disrupters to the British National Biomanufacturing Centre (NBC) in Speke, Liverpool. The new equipment uses a unique ‘knife edge’ type valve to provide the maximum yield of cell material.
The NBC gives start-up companies the facilities to trial manufacturing methods and attract investors for new drug production. NBC provides appropriate cGMP facilities to develop the drugs in the first place 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 cell disrupter units rupture mammalian and bacterial cells to release the active material inside. They consist of high-pressure homogenisers and associated equipment designed to extract cell material with a very high degree of efficiency without damaging the product itself.
The Niro designed skids, the first incorporating a Niro Soavi NS3006H high pressure homogenizer, 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 and 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 of the cell disrupter units 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 trials, using E-Coli for example, have achieved 94% cell disruption with two passes at 1000 bar using this technology. Niro prefers to use two passes at 1000 bar rather than 1500 bar because increased pressure increases temperature – approximately 2°C per 100 bar – and this can damage heat sensitive material.
The NBC can produce sufficient active material for clinical trials but is not designed for full production. The Niro NS 3006 H cell disruption equipment, however, 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 NS 3018 or NS 3037 machines, both of which have similar characteristics to the 3006.