Jean Bléhaut PresidentPresident, Manufacturing Solutions Business Unit Novasep

In response to growing demand for specialized capabilities in biologics, Novasep is launching a series of major projects to boost its biomanufacturing capacity for select types of drug substances and fill/finish activities. Jean Bléhaut, President, Manufacturing Solutions Business Unit, Novasep outlined the expansions at the DCAT Week ’18 Member Company Announcement Forum, which was held Monday, March 19, 2018 in New York.

Novasep is investing $20 million in a new cGMP monoclonal antibody (mAb) manufacturing facility at its site in Pompey, France for small-volume mAb production for targeted therapies, orphan drugs, and antibody-drug conjugates (ADCs). Scheduled to be operational by mid-2019, the plant will feature upstream processing and downstream processing suites equipped with single-use 50-L, 200-L, and 500-L bioreactors and Novasep’s BioSC low-pressure chromatography system. The BioSC technology is part of Novasep’s proprietary downstream processing platform to enable flexible downstream processing in batch and/or continuous modes. With the inauguration of Novasep’s $13-million ADC conjugation facility at it site in Le Mans, France in 2017, Bléhaut says the new mAb facility further reinforces the company’s end-to-end ADC drug substance offer.

Viral vectors for gene therapies are another strategic focus of Novasep, which Bléhaut addressed in his presentation. Project Senrise, Novasep’s $33-million investment in a new commercial-scale production facility, which is ongoing at the company’s site in Seneffe, Belgium, will be fully qualified by the first quarter of 2019. The site will feature two cGMP manufacturing lines equipped with a set of single-use bioreactors ranging from 50 L up to 2,000 L to meet production requirements for Phase III development and commercial production.

Bléhaut explained that the plant is being planned in response to strong market demand driven by both a growing interest in this therapeutic approach and a maturing clinical pipeline. Viral vectors are used in gene therapies or immunotherapies, such as in new cancer treatments, and in “new generation” therapeutic vaccines. With more than 500 gene-therapy candidates in different stages of clinical development and nine products launched, the market is expecting to see high single-digit growth over the next five years, according to information from the company.

Novasep is complementing these expansions with “SeneFill,” a $12-milion investment in a commercial facility for fill/finish at its site in Seneffe, Belgium to boost its drug-product services for mAbs, viral vectors, and other low-volume biopharmaceuticals.

With this $65-million investment for new biomanufacturing capacities, Bléhaut said Novasep is fully engaged in its RISE-2 strategic plan, which is aimed at doubling the company’s size by 2022.