Gwenael Servant, PhD Senior Director, Servier Contract Manufacturing Servier CDMO

Servier CDMO, the contract development and manufacturing organization of the French pharmaceutical company, Servier, is investing $55 million for biologic-based drug-substance and drug-product manufacturing and has invested $7 million to expand its preparative chromatography infrastructure. Gwenael Servant, PhD, Senior Director, Servier Contract Manufacturing, highlighted the expansions at the DCAT Week ’19 Member Company Announcement Forum, which was held March 18, 2019 in New York.

In November 2018, Servier broke ground for a new bioproduction unit at its industrial site in Gidy, France. Called Bio-S, the unit will produce biologic-based drug substances and drug products (prefilled syringes and vials). The future unit will be responsible for the manufacture and packaging of monoclonal antibodies, initially in the form of preclinical batches, then clinical batches. With a surface area of more than 6,000 square meters, the Bio-S unit will assemble various activities, including a development workshop dedicated to monoclonal antibody processes (bio-engineering), which will be operational in early 2020. The rest of the unit, grouping all the steps to deliver injectable products, will be operational in 2021. Bio-S is a project jointly led by the research and development and industry teams of Servier and is the result of an investment of $55 million over three years as well as regional, national, and European research and development grants. Initially, Bio-S will have approximately 30 employees and close to 60 employees by 2022.

The Bio-S project began work at the end of 2018 and key upcoming milestones are: the purchase of equipment in the spring of 2019; the first installations of the process development workshop dedicated to monoclonal antibodies (bio-engineering) in the first half of 2020; the start of preclinical batches production activities for research in 2020; and the launch of clinical batch production by 2021.

Separately, Servier has invested $7 million in equipment and expansion of its preparative chromatography infrastructure at its drug-substance facility in Normandy, France. The company’s proprietary system, InnoPreP, encompasses the capability for either continuous processing using simulated moving bed (SMB) chromatography or six-column batch chromatography at lab to industrial scales. The company added a new 500-square meter space to house continuous processing using SMB technology, which the company says can achieve greater yields from fewer starting materials and is efficient for racemic separations. The unit also uses green technology with supercritical carbon dioxide and a falling film evaporator recycles up to 90% of solvent. The InnoPreP area also has high containment to enable handling of highly potent compounds down to OEB 5, serving companies seeking to develop highly potent active pharmaceutical ingredients for oncology drugs. InnoPreP was built in 2018 and was became fully operational in the first quarter of 2019.