The U.K.-based processing technology provider said on Friday that its $10 million investment will create a state-of-the-art, dual-stream facility for process development, manufacturing, quality control, quality assurance and stability testing of ADCs (antibody-drug conjugates).
ADC drugs target tumor cells directly, without the side effects common in conventional chemotherapy.
The 1,500-square-meter manufacturing facility at ADC Bio’s operational headquarters in St Asaph, North Wales, is planned to start operating in mid-2017. It will be able to produce clinical trial and low-volume commercial quantities in cutting-edge cleanroom facilities, using both conventional, solution-phase production and ADC Bio’s proprietary ‘Lock-Release’ technology.
This processing technique ‘locks’ antibodies onto a solid polymer bead, enabling the drug to be conjugated with the antibody using a specialized chemical linker. The ADC is then ‘unlocked’ as a clean drug product by a chemical ‘key’.
A projected second phase of the project will add another 2,500 square meters of manufacturing space for larger-scale clinical and commercial manufacturing.
“ADC manufacturing at larger scales is a fast-emerging global market opportunity,” said ADC Bio CEO Charlie Johnson. “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.”
ADC Bio estimates that the world market for clinical trial contract manufacturing of these new therapies could triple to over $150 million by 2018.