Novasep, heeding the next-gen oncology call, boosts high-potency drug ingredient capacity

With so many customers working on cutting-edge cancer treatments, CDMO Novasep says demand for antibody-drug conjugate manufacturing is booming.

Heeding the call, Novasep on Wednesday said it plans to beef up capacity for highly potent active pharmaceutical ingredients (HPAPIs)—a key component of the treatments—at its plant in Le Mans, France. The increase to both clinical and commercial capacity will be fueled by a more than €4 million ($4.83 million) investment and at least 30 new hires at the site. 

Still relatively fresh in the oncology realm, ADCs use a chemical linker to combine a monoclonal antibody with a potent cancer drug payload. The antibody then homes in on specific antigens in target cells, allowing the drug to go to work without damaging the cells around it. 

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The French CDMO opened its Le Mans bioconjugation facility back in 2017, when there were a slim two ADCs on the market. But the company saw promise in the field. And it wasn't wrong: Since then, a suite of ADCs like AstraZeneca and Daiichi Sankyo's breast cancer med Enhertu and GlaxoSmithKline's multiple myeloma treatment Blenrep have entered the fold—and those are just a couple of recent examples. 

The €12 million, 2,000-square-meter facility debuted with two flexible production suites capable of handling projects from 10 liters to 400 liters. Bioconjugation would round out the company's ADC repertoire, which already included commercial-scale production of ADC payloads, drug linkers and monoclonal antibodies, Novasep said at the time. 

The plant is now delivering ADC batches to clients and passed an inspection by France's drug regulator, ANSM, earlier this year, Novasep said. 

RELATED: CDMO Sterling plots buyout of antibody-drug conjugate specialist in play at next-gen oncology market

While its ADC prowess is on the ascent, Novasep has slimmed down in other areas this year. In the first week of January, Novasep lined up a sale of its chromatography equipment division to Sartorius Stedim Biotech. Shortly after that, Thermo Fisher Scientific laid out €725 million ($878.2 million) to buy Novasep's viral vector manufacturing division, Henogen. 

Novasep isn't the only manufacturer making ADC moves, though. Merck KGaA's MilliporeSigma unit in September said it would throw down $65 million to build a new commercial facility near its Madison, Wisconsin, plant to increase production of HPAPIs for ADCs. Pegged for completion in mid-2022, the Wisconsin facility will join another MilliporeSigma ADC site in St. Louis.

Meanwhile, Sterling Pharma Solutions in April acquired British ADC specialist ADC Biotechnology, with a view to start bioconjugation and production at the company's plant in 2022.