The Le Mans site has already benefitted from significant investment.
Now, to support further growth and to sustain the increase in both clinical and commercial production capacity at the facility, the contract development and manufacturing organization (CDMO) is investing more than €4m (US4.84m) in the site, with it also set to boost employees numbers there; over 30 new hires are planned.
ADC manufacturing services
In making its announcement this week, the French company also noted increasing customer demand for manufacturing services for Antibody Drug Conjugates (ADCs). It opened its Le Mans bioconjugation facility back in 2017, with it ploughing €12m into those operations at the time. At the outset, the standalone had two flexible GMP production suites equipped with 10L to 400L vessels to support both clinical and commercial manufacturing of ADCs. Today, it allows commercial-scale production of ADC payloads, drug linkers and monoclonal antibodies.
ADCs are particularly complex to produce because they are composed of a biological part – the monoclonal antibody, and a chemical part - the linker and the highly potent payload. The conjugation is the critical process step where both parts are assembled.
The plant is now delivering ADC batches to customers and Novasep says it passed an inspection by France's regulator, ANSM, earlier this year.
As well as facility expansion, Novasep has been divesting assets. In January this year, it set in motion a deal to sell its chromatography equipment division to Sartorius Stedim Biotech. The unit employs around 100 people, the majority working at Novasep’s site in Pompey, France.
That same month saw Thermo Fisher Scientific acquire Novasep’s viral vector manufacturing business, Henogen, for €725m. That business is run out of two locations - in Seneffe and Gosselies, Belgium; the viral vector operations include more than 7,000 square meters of state-of-the-art clinical and commercial manufacturing capacity.
Founded more than 20 years ago, Henogen employs around 400 staff, with substantial operational and technical expertise in a broad range of viral vector classes. Thermo Fisher said the deal fits in well with its recent investment in its clinical and commercial capabilities, in the US and also in facilities in the UK and Germany, for cell and gene-based therapies. The CDMO is planning to expand the development and scale of Henogen’s viral vector services portfolio.