Catalent Pharma Solutions has acquired the license to market the proprietary SMARTag technology from Redwood Bioscience in order to develop advanced antibody-drug conjugates (ADCs) and has entered into an increasingly populated segment of the services market as drugmakers continue to drive demand for these high end products.
“ADCs are a fast growing area of biologics development and many of our customers are pursuing this approach to create their next generation of biologic therapies,” said Michael Riley, VP of Strategy, Medications Delivery Solutions at Catalent, speaking to Outsourcing-Pharma.com.
ADCs are monoclonal antibodies designed to target specific cancers by combining highly potent (and normally intolerable) anticancer molecules together, and though there are relatively few approved ADCs on the market at present (just two in the US following the FDA’s approval of Genentech’s breast cancer drug, Kadcycla), levels of investment by pharma and manufacturing companies are on the rise.
Many recent investments in ADCs have come from contract manufacturing organisations (CMOs) looking to offer high value manufacturing capacities. Lonza, for example, announced in January it would double its ADC capacity and just weeks later Synthon unveiled a new Dutch ADC facility. Other recent investments include ones by Fujifilm and Piramel, Baxter and French company Novasep.
However, Catalent says its interest lies beyond ADC capacity: “We are pursuing a technology-led strategy for our participation in biologics and ADCs,” Riley explained.
“We believe that by providing the most advanced technologies and development solutions, we can help customers to create better biologic treatments. Our goal is to compete as a technologies and solutions provider, and not simply based on manufacturing capacity.”
New Tech, New Facility
The licensing of Redwood’s “site-specific conjugation” SMARTag platform will in combination with Catalent’s own GPEx platform and the opening up of a new facility, can, according to Riley, “create significant value for our customers in their biologics development.”
The Madison, Wisconsin facility, announced in 2011 and formerly operated by GE Healthcare, will - said Riley - offer “cell line engineering, process development, and cGMP biomanufacturing from 10 to 1000 Liter scale using single-use disposable technology.”
He continued: “We will have the capability to produce aldehyde “tagged” antibodies developed using the SMARTag system at our site in Madison, and will offer development-scale conjugation through our partner, Redwood Biosciences.”