Alpha breaks ground on construction of new cGMP biomanufacturing plant
Construction has started on Alpha Biologics' new 5,000 sq metre mammalian cell biomanufacturing plant on the Penang Biotech Park in Malaysia. It is planned that the facility will be ready for FDA/EMEA cGMP-compliant operation during 2008. The Penang facility is being constructed to an FDA-approved design and is primarily dedicated to the production of mammalian cell secreted proteins, such as monoclonal antibodies and recombinant proteins.
The facility includes three isolation suites for USP-cell banking and related activities. Stirred tank vessels, ranging in volume from 10 to 500 litres, combined with perfusion technology will significantly increase productivity per vessel, allowing ultra-efficient production. The facility also includes two separate DSP suites and separate final filtration/viral removal suites.
Alpha already carries out scientific research and process development services at its European facility at Babraham, Cambridge, but only up to around 10 litre capacity. The combination of these services with the new Penang cGMP manufacturing base will allow Alpha to offer customer services from research stage all the way through to clinical trials or early market supply.
The combination of lower operating costs compared to the US and Europe and the new plant's high productivity will allow Alpha to significantly reduce manufacturing costs for clients, while still ensuring that they receive full cGMP manufacturing compliance.