UK-based ADC Biotechnology has secured investment for the construction of an $11 million* bioconjugation facility at its new site in Deeside, North Wales, UK.
The specialist antibody-drug conjugate contract services company with proprietary conjugation technology designed to overcome process and aggregation challenges during the development of new antibody-drug conjugates,
The new 6,500 m2 facility – scheduled to be operational by December 2018 – is expected to support manufacturing in all clinical phases and small-scale commercial production of antibody-drug conjugates. The new facility includes GMP production suites equipped with vessels of 10 up to a few hundred liters for batch sizes from 100 grams up to a kilo. The integrated facility is also expected to complement ADC Biotechnology’s long established technical services business that provides small scale R&D through to preclinical testing, with three on site laboratories and analytical testing capabilities.
The company’s move into clinical and commercial ADC manufacturing is particularly significant as it already boasts a strong pipeline of customers – thanks to its patented ‘Lock-Release’ technology and the extensive experience of its senior scientists.
The aggregation control platform is currently used by over 20 customers, including a number of ‘big pharma’ as well as smaller biotechnology companies. The ‘Lock-Release’ technology results in fast, simple and robust conjugation processes with the potential to eliminate several process steps while, at the same time, enhancing product quality.
This process is expected to help overcome aggregation challenges from the more complex, potent and hydrophobic payloads increasingly coming through discovery and development. The ADC Biotechnology technology immobilizes protein elements, keeping them separated up to the point they are conjugated – ensuring that much cleaner drug products are ultimately released and that the quality and yield of highly aggregated systems are managed in one single step. The technology will also be available for licensing and sub-licensing 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,” noted Charlie Johnson, Chief Executive Officer of ADC Biotechnology.
The purpose-built, dual stream bioconjugation facility will provide a suite of capabilities ranging from R&D technical services, quality control, QA, warehousing, and process development through to manufacturing – all of which will occupy just 50% of the unit’s footprint. Consequently, ADC Bio will have free capacity to upscale quickly from early clinical phases into late phase and commercial manufacturing within the same footprint at the new facility.
Subsequent phases are planned for 2018 and beyond and will add further capacity for large scale clinical and commercial, and potentially, dosage form production (fill/finish).
“We are already preparing for future phases of development and the medium-term manufacturing pipeline for the business looks extremely strong. But longer term, we also have a lot of USPs – as a standalone site with patented Lock-Release technology – which makes us extremely attractive.” added Johnson.
ADC Biotechnology’s senior management and scientific team have decades of professional experience of developing ADCs both at ADC Bio and at rival CDMOs. Several of the company’s senior management were pivotal to the development and commercialization of Adcetris – the world’s first approved ADC. And, the company is already an integral part of the growing North West pharmaceutical manufacturing hub.