State-of-the-art processing areas and technologies were designed into the Penang cGMP biomanufacturing facility to provide maximum flexibility, allow parallel processing, minimise throughput time and cost to the customer.
Upstream Advanced Bioprocessing Areas: these are designed to perform a number of stages in parallel, enabling us to move through each stage of process development and manufacturing as quickly and efficiently as possible - whilst still ensuring cGMP compliance. By doing this we can deliver product earlier than expected, significantly reducing the cost of development programmes.
The cGMP manufacturing plant has a Process Development facility incorporated into the entire facility. It is equipped with identical technologies to the cGMP production suites, thus ensuring seamless transition to production once a process is ready. The Upstream Process Development area operates with its own dedicated team of experienced staff. This team works closely with cGMP manufacturing staff to ensure that there is a clear understanding of process requirements and specifications - and a smooth transition of the process at the appropriate time.
Downstream Advanced Bioprocessing Areas: these are purpose-designed to complement the flexibility, capacity and process flow through the upstream phases - once again ensuring that we are able to meet client needs from early development through to the delivery of purified product for pre-clinical, clinical trial or market use.
As with upstream processing, the cGMP manufacturing plant has a Downstream Process Development facility incorporated into the entire facility. Downstream Process Development areas are equipped with identical technologies to cGMP purification suites - and operate with its own dedicated team of experienced staff, who work with cGMP staff to ensure a clear understanding of process requirements and specifications and a smooth transition to cGMP manufacturing.
The degree of integration of the upstream and downstream processes enable us to significantly reduce the normal timelines for process development and cGMP manufacture, resulting in significant cost savings for clients.
Contact us on +44 (0) 1223 496070 (UK), +60 (0) 4 5048800 (Malaysia) or firstname.lastname@example.org for a quotation or further information.