Novasep has opened its new EUR 11-million ($11.6-million) bioconjugation facility at its site in Le Mans, France, for clinical and commercial manufacturing of antibody-drug conjugates (ADCs).
The 2,000 square-meter facility has two flexible GMP production suites equipped with 10-liter to 400-liter vessels to support clinical- and commercial-scale ADC manufacturing. The stand-alone facility also offers research and development services, quality control, and scale-up laboratories.
The new facility completes Novasep’s ADC manufacturing platform, which includes ADC payloads, drug linkers, and monoclonal antibody (mAb) commercial-scale production capabilities.
ADCs are composed of a biological component (mAb) and chemical components (linker and a highly potent payload). Conjugation is the process step where both parts are assembled, according to Novasep.
Currently, there are only two ADCs approved on the market, Seattle Genetics’ Adcetris (brentuximab vedotin), indicated for treating classical Hodgkin lymphoma and systemic anaplastic large cell lymphoma, and Roche’s Kadcyla (trastuzumab emtansine), indicated for treating HER2-positive, metastatic breast cancer.
Seattle Genetics, a Bothell, Washington-headquartered biotechnology company, developed Adcetris in collaboration with Takeda Pharmaceutical. Adcetris, which had 2016 sales of $265.8 million, is commercially available in 65 countries, including the US, Canada, Japan, and members of the European Union.
Roche licenses technology for Kadcyla under an agreement with ImmunoGen, a Waltham, Massachusetts-headquartered clinical-stage biotechnology company that develops targeted cancer therapeutics using its proprietary ADC technology. Kadcyla had 2016 sales of CHF 831 million ($822 million).