DEESIDE, U.K.—Aimed at speeding, simplifying and lowering production costs of the latest generation of anticancer drugs, ADC Biotechnology (ADC Bio) has invested $11 million into construction of a high-tech, state-of-the-art bioconjugation plant at its new site in Deeside, North Wales. The icing on the cake is ADC Bio’s proprietary “lock-release” technology, a new paradigm in that antibody-drug conjugates (ADCs) are developed and manufactured at lower costs and reduced environmental impact.
With “lock-release” technology, antibodies or ADCs covalently “lock” to solid polymer beads, prior to conjugation and ultimately release as clean drug substance, making for smaller production and containment footprints, thus minimizing risk to high-value drug components.
“Essentially, these state-of-the-art complex payloads can be very problematic from an aggregation perspective, which is where the ‘lock-release’ technology provides a solution—a unique form of aggregation control—that is essential for such new cytotoxic payloads,” says Charlie Johnson, CEO of ADC Bio. “The ‘lock-release’ technology is unique to ADC Biotechnology, a step-change technology that is set to provide the best process solutions to its clients and significant value creation for ADC Bio’s supportive shareholders.”
The new 6,500-meters-squared (70,000 square-foot) facility will support manufacturing in all clinical phases and small-scale commercial production of antibody drug conjugates, Johnson says.
This location will be 20 times the company’s current size, with an operational increase of six times in the first phase of the new facility’s development, leaving a further 4,000 meters squared for planned expansion. Having completed the design of the first phase of expansion over the last 12 months, the plant should be fully validated and operational by the third quarter of 2018.
“The new facility provides a manufacturing platform for ADC manufacturers who want to utilize not only the ADC Bio’s ‘lock-release’ aggregation control technology, but the manufacturing of ADCs based on conventional solution-phase bioconjugation techniques,” Johnson tells DDNews.
“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 U.S. and Europe,” he adds.
The dual-stream bioconjugation facility will provide a suite of capabilities ranging from R&D technical services, quality control, quality assurance, warehousing and process development through to manufacturing—all of which will occupy just 50 percent of the unit’s footprint, according to Johnson. Consequently, ADC Bio’s new plant will have free capacity to upscale quickly from early clinical phases into late-phase and commercial manufacturing within the same footprint.
The main initial focus for manufacturing operations will be “first-in-man” ADCs, Johnson reports. The new facility provides ADC Bio with the capability to manufacture commercial ADCs, equivalent to Adcetris, to the scale needed to meet all its global demands year on year, with room to grow, he says.
According to Johnson, the aggregation control platform is currently used by over 20 customers, including Big Pharma, and helps overcome aggregation challenges from the more complex, potent and hydrophobic payloads appearing more frequently in discovery and development.
“We are already preparing for future phases of development, and the medium-tier manufacturing pipeline for the business looks extremely strong,” Johnson says. “But longer term, as a standalone site with patented technology, it makes us extremely attractive.”
With surging numbers of “second-generation” drugs in development (currently around 200) tumor-selective ADCs are building a significant position in the oncology field, the fastest-growing sector in healthcare.