Pall Corporation will implement its end-to-end solutions for the development and manufacture of monoclonal antibodies (mAbs) and recombinant proteins at Servier’s Gidy, France facility.
Servier’s facility is part of the Bio-S project, which focuses on delivering support for oncology drug production from R&D to clinical scale.
Renaud Bessière, director of the Bio-S project at Servier, said in a statement, “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.”
A filtration, separation and purification-focused company, Pall will work at the facility to provide equipment to accelerate the process of mAb and protein production.
Ed Hoare, Vice President and General Manager of Pall Biotech told us, “This is the first biotech facility for Servier Group, so this is a big change as [the Gidy facility] was specialized for tablets. The revamping is strategic for Servier, so there are huge expectations in terms of time to market, respect of budget and transfer of know-how from a supplier.”
Bio-S project: ‘A partner in development’
The Bio-S project includes production lines to also support internal production, with a 2,000L bioreactor capacity. It will also provide all of the steps required to deliver an injectable product, a function set to be operational by 2020.
Additionally, Servier will use the Bio-S unit to provide a development workshop for mAb processes.
Pall will supply its Allegro product portfolio of bioreactors, mixers, storage tanks, TFF and consumables as part of the arrangements. The Allegro line also uses a polyethylene contact film for all its biocontainers in the process, said Hoare.
Pall will also act as a co-development partner for all customer production steps at the facility.
Servier is building infrastructure through the Bio-S project to enable it to become a partner in the development of therapeutics in oncology by offering customer support from R&D through the manufacture and packaging of mAbs. Hoare added, “This first facility will be the platform, which could be duplicated as success is achieved.”
He also told us that the plan is for the facility to start producing full scale by the end of 2019. Pall will use all new tools to train Servier, such as e-learning, videos, handoff sessions, and knowledge checks, while it manufactures the equipment to enable Servier to be operational as soon as the equipment arrives at Gidy.