The UK-based processing equipment firm announced its involvement this week. It explained it had tailored existing technologies to meet the requirements of the experimental process development work due to be carried out at the recently constructed centre.
The NBMC is built to comply with Category II containment standards set out in European biosafety rules. Under Category II all waste generated there must be treated with the same care as material from labs that handle HIV, hepatitis and influenza viruses.
In practice this means all liquid waste produced at the NBMC – including the culture media used during process development work – must be collected and denatured prior to being disposed of in the site’s drainage system.
Suncombe told us its "systems are often used in the research areas rather than established manufacturing processes, so incorporate a number of different facilities to ensure that the effluent can be suitable stored and treated even when throughput is not continual.
"Our systems are customised for every specific application and this system included out-of-hours cooling to save cooling load, emergency tanker discharge, pH control, positive release of treated waste and trends/records etc."
The system in place in Darlington can handle anything from a few hundred litres per day to 1,000s of litres per hour according to Suncombe, which added that it can be used for the treatment of "biopharmaceutical products, cell lines and cultures to biohazard levels CL 2, 3 and 4."
Pump down the volume?
How much waste the Suncombe system actually treats will depend on the success of the facility, given that the volume of liquid generated will be directly linked to the number of projects that are carried out.
According to the Centre for Process Innovation (CPI) – the organisation that manages the NBMC – the centre was designed to be flexible enough to accommodate a wide range of manufacturing systems and process development activities.
However, the CPI also wants to create the “biologics factory of the future” that is capable of supporting process development activities for personalised, low volume biopharmaceuticals.
Last June the organisation told us “The production of small volumes of an increasing number of therapies is not practical or cost effective in the current manufacturing formats.
“There are a number of potential solutions to this challenge, including scaling down and integrating process technologies into a small scale single format manufacturing unit which can rapidly change between different products and can produce small volumes of specific therapies cost effectively.”
NBMC director, Fergal O’Brien, emphasised this today and explained that all of the processing systems must be capable of handling a range of manufacturing systems and production volumes.
“It is vitally important that the effluent treatment facilities are able to cope with a range of products and remain fully compliant with the Category II containment requirements.”