Monday, August 10, 2015

Designing and building next gen biomanufacturing facilities in Asia

Singapore has become a significant hub for biopharmaceutical companies looking to manufacture in Asia. Locating manufacturing facilities in Asia allows companies to product biologics close to important and expanding markets and improve their cost structure. Amgen is one such company that is increasing its presence in Asia with a $160 million investment to build a manufacturing facility in Singapore for the production of denosumab the active ingredient in Prolia and XGEVA. Regulatory filing is expected to take place in 2016.

Amgen’s next generation biomanufacturing facility
Kimball Hall, Vice President of Manufacturing and site head at Amgen Singapore Manufacturing Pte. Ltd. will be presenting at Bioprocess International’s 2015 Conference and Exhibition in Octoberon “Amgen’s next generation biomanufacturing facility”.

The facilities smaller, modular design will allow it to be readily replicated for future facilities in order to increase capacity while expanding the company’s global network and reach. It will heavily utilize single-use technologies including bioreactors up to 2000L in scale. Also of interest is Amgen’s choice to make use of continuous processing steps which is a topic I’ve covered in this blog previously.

Next gen facility saves time and money
The approach that Amgen has adopted is set to save the company money. In a recent interview Kimball was quoted as saying Amgen’s “next-generation biomanufacturing require ¼ of the capital costs, 1/3 of the operating expense; and half of the construction time” (Inside Look at Amgen’s Next-Gen Biomanufacturing by Denice Cabel).

The environmental impact of single-use technologies
Interestingly, Amgen considers the use of disposable technology as being more environmentally friendly than traditional stainless steel plants. This for many is counterintuitive as they see the single-use technologies made from plastics as part of a throwaway culture but they neglect to consider the considerable energy and water requirements needed to produce the clean steam, WFI and cleaning solutions that are required to prevent contaminations in reusable bioprocessing equipment.

Global supply chain networks are becoming increasingly important as was highlighted in last week’s post on final fill finish operations. Interestingly the trend to develop these networks is driving innovation and the adoption of novel technologies.
Have your say
Singapore has a significant cluster of biomanufacturing facilities and is important on the global stage. Where do you see the next big hub developing?

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Dr Nick Hutchinson has a Masters and Doctorate in Biochemical Engineering from University College London, UK where he focused on laboratory tools for rapid bioprocess development and characterization. He then worked at Lonza Biologics in an R&D function investigating novel methods for large-scale antibody purification before moving to an operational role scaling-up and transferring manufacturing processes between Lonza sites in the UK, Spain and USA. Nick now works in Market Development at Parker domnick hunter where his focus is in bringing Parker's strengths in Motion & Control to Bioprocessing. This will enable customers to improve the quality and deliverability of existing and future biopharmaceuticals.

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