ADC Biotechnology is investing $11 million to build a bioconjugation facility at its new site in Deeside, North Wales, UK. The new facility will provide a suite of capabilities ranging from R&D technical services, quality control, QA, warehousing, and process development through to manufacturing. As a result, ADC Bio will have free capacity to upscale from early clinical phases into late phase and commercial manufacturing within the new facility.
 
The 6,500m² facility – scheduled to be operational by December 2018 – will support manufacturing in all clinical phases and small-scale commercial production of antibody drug conjugates. It will provide GMP production suites equipped with vessels of 10 to a few hundred liters for batch sizes from 100 grams up to a kilo. The new facility will be integrated with the company’s technical services business that provides small scale R&D through to preclinical testing, with three on site labs and analytical testing capabilities.
 
The company will offer its ‘Lock-Release’ technology, an aggregation control platform designed to help overcome aggregation challenges from the more complex, potent and hydrophobic payloads. The technology ensures that much cleaner drug products are ultimately released and that the quality and yield of highly aggregated systems are managed in one step. The technology will also be available for licensing and sublicensing in the future. 
 
“We already have confirmation that many of our existing customers will use the facility for clinical development and we anticipate adding a number of the new targets entering clinical development from customers in the USA and Europe – especially in light of the added value we can provide through Lock-Release. For many of the newer types of payload this could well be the difference between a viable product and not” commented Charlie Johnson, chief executive officer of ADC Bio.
 
Subsequent phases are planned for 2018 that will add further capacity for large scale clinical and commercial, and potentially, dosage form production (fill/finish).