Pall Corporation and CDMO Servier have announced a single-source supply agreement for a new site in Gidy, France, which is part of Servier’s launch into biotech in the region. As part of the agreement, Pall becomes an exclusive technology and services provider for the new project.
Gidy is located near Orleans, 100 km from Paris. The site was built in 1972 and has four production units: two dedicated to dry forms, one dedicated to liquid and spray forms nearby in Fleury-les-Aubrais, and one additional unit that is currently being transformed into a biotechnology unit. Servier said the launch is scheduled later in 2019.
End-to-end solutions from Pall Biotech will be implemented for the development and manufacturing of monoclonal antibodies (mAbs) and recombinant proteins, resulting in increased speed to market and reduced customer costs.
End-to-end solutions from Pall Biotech will be implemented for the development and manufacturing of monoclonal antibodies
Ed Hoare, Vice President & General Manager at Pall Biotech, commented: “Pall was chosen as a single vendor for our unique ability to offer integrated solutions that help to guarantee supply chain security for customers and patients while allowing data to be collected and organized efficiently. We are honoured to have been chosen and look forward to delivering comprehensive and scalable biomanufacturing solutions from upstream to downstream and through to fill and finish, as well as process development service expertise."
Oncology drug products
The facility is part of the Bio-S project at Servier focused on delivering best-in-class support for oncology drug production from research and development (R&D) to clinical scale.
The Bio-S project at the Gidy facility includes production lines to support internal production needs with up to 2,000L bioreactor capacity that can be run in a parallel format.
The Bio-S unit aligns various activities, including a development workshop dedicated to monoclonal antibody processes (Bio-engineering) which will be operational by 2019. The rest of the unit grouping all of the steps to deliver an injectable product to humans will be operational in 2020.
“The Bio-S project in Gidy is the beginning of an industrial solution for biomanufacturing in France, offering an innovative path for critical oncology therapies, one of the main strategic priorities for Servier,” said Renaud Bessière, Director of the Bio-S Project at Servier.
“We selected Pall Biotech as our single supplier because of their capacity to deliver the complete suite of development and manufacturing equipment, including an automation package, assurance of consumables supply and technical support under a well-defined project execution plan.”
Through the Bio-S project Servier is building infrastructure that enables the company to be a key partner in the development of new therapeutics in oncology, offering customer support from R&D through to manufacture and packaging of monoclonal antibodies, initially in the form of preclinical batches, then clinical batches.