The £125,000 ($190,000) investment for the St. Aseph, North Wales-based company will see a new technical service laboratory added to its site in order to meet growing demand for the company’s R&D services from pharma companies developing ADCs.
Speaking with Outsourcing-Pharma.com, CEO Charlie Johnson said the investment “provides a more extensive capability, up to and including pre-clinical Tox, to offer ADC services including proof of concept using [its] proprietary 'Lock-Release' technology.”
He added that expansion was necessary as “overall demand for ADC services and material supply is increasing sharply and is overhauling supply.”
The new lab will bring together analytical and preparative equipment and skill sets in one integrated space and will allow the company’s original lab to be dedicated to the "lock-release" tech that received a £600,000 boost in January.
The technology differs from existing methods in ADC manufacturing as the drug is bound to the targeting antibody while it is attached to a solid surface, rather than being carried out in a high concentration of reagent.
Johnson said such deployment in a multi-well plate format “shortcuts the need to manage typical early challenges, e.g. ADC aggregation, free drug and solvent clearance issues” and is increasingly “enabling 'next generation' ADCs that cannot be accessed via conventional solution phase processes.”
ADC Demand
Recently there has been a lot of action from contract manufacturing organisations (CMOs) big and small in expanding their presence in ADC development, including within the last few weeks Catalent’s technology and facility investment and Goodwin Biotechnology’s collaboration with Coldstream Laboratories.
One major factor that has sped up interest is February’s approval by the US Food and Drug Administration (FDA) of Genentech’s (Roche's) drug, Kadcyla, which became only the second commercially available ADC in the US after Seattle Genetic’s Adcetris in 2011.
ADC Bio has seen a rise in business from a mix of large pharma and biotech companies, referred to by Johnson as “the 'fast followers' who have anticipated the success of Adcetris and Kadcyla.”
According to ADC Bio, the number of ADCs in trials over the last 18 months has risen sharply, and the number in development is now in its hundreds.
In-House Development?
Though the industry is presently looking at CMOs and partnerships to develop ADCs – such as in the recent $112m collaboration between Bristol-Myers Squibb and Ambrx – we asked Johnson if the rise of ADCs entering clinical trials would lead to more pharma companies developing ADCs in-house.
“This cannot be discounted but will be dependent on the relative success of individual companies ADC portfolios.”
He added: “This is why we are pursuing differentiation through 'Lock-Release' which will also provide a step-change in manufacturing productivity and economics, as ADCs progress through clinical trials to the market.”