Investment will enable antibody drug conjugates to be made in sufficient quantities for large scale clinical trials
UK-based ADC Biotechnology (ADC Bio) has announced a £6.5m (US$10m) plan to build a 1,500m2 manufacturing facility for advanced anticancer drugs. The two-stage expansion programme marks the transition of ADC Bio into GMP manufacturing of antibody drug conjugates (ADCs) and will create more than 60 new science jobs at completion.
The investment responds to demand by drug developers and a shortage of capacity to make these new drugs in quantities sufficient for large scale clinical trials. Phase 1 of the project will come on stream in mid-2017, creating a 1,500m2 state-of-the-art, dual-stream facility for process development, manufacturing and quality testing of ADC drugs. From both scale and regulatory perspectives, the new facility will be able to produce clinical trial and low-volume commercial quantities. Production will be in cutting edge cleanroom facilities, accommodating both ADC Bio’s proprietary 'Lock-Release' technology and conventional, solution-phase production.
The facility will bring process development, manufacture, quality control, quality assurance and stability testing together under one roof at ADC Bio’s operational headquarters in St Asaph, North Wales.
A projected second phase is planned to add another 2,500m2 of manufacturing space for larger scale clinical and commercial manufacturing.
The fastest-growing segment of oncology therapy, ADC drugs target tumour cells directly, without the side-effects common in conventional chemotherapy. ADC Bio estimates that the world market for clinical trial contract manufacturing of these new therapies could triple to over $150m by 2018.
ADC Bio is the market’s only contract technical services company specialising in manufacture based on its own patented technology. The unique 'Lock-Release' platform technology ‘locks’ antibodies onto a solid polymer bead support for the entire process. The drug – typically a potent cytotoxin – can then be conjugated with the antibody using a specialised chemical linker to form the ADC, which is then ‘unlocked’ as clean drug product from the support by use of a chemical ‘key’.
'Lock-Release' is faster, simpler and less vulnerable to processing errors and batch risks to high value materials than multi-stage, solution-based processing, according to ADC Bio.
'This exciting project marks a key extension of our business model into larger-scale clinical trial and commercial drug manufacturing, in response to our customers’ demands,' said ADC Bio’s CEO Charlie Johnson. 'ADC manufacturing at larger scales is a fast-emerging global market opportunity. Our ‘Lock-Release’ enabling technology is set to revolutionise ADC manufacturing, by enabling process development for the next generation of ADC drugs and helping to reduce future production costs in one of the fastest-growing sectors of healthcare.'