Servier has selected Pall Corporation as its exclusive technology and services provider at its biomanufacturing facility in Gidy, France.
The facility, located about 50 km south of Paris, forms part of Servier’s oncology drug development and production network, Bio-S. This unit will be used for the manufacture of recombinant proteins and monoclonal antibodies, using equipment and processes supplied and supported by Pall Biotech.
“Pall will assist Servier with technical support for the scale up of the process to enable Servier to transfer the small case process (on benchtop) to the bioprocessing line and afterwards to the bioproduction lines,” Ed Hoare, VP and general manager of Pall Biotech, told this publication.
“This means that the selection of the purification steps from the very beginning has to be in line with Servier’s platform, which is fully compatible with Pall equipment. Thus, no further tests and no requalification are required. The yield of each step, whatever the scale, will be repeatable and every optimization at small scale can be easily implemented at larger scale.”
Pall will also support Servier with all small devices to conduct feasibility and validation testing for small scale to screen the right Pall consumable, before deploying it at larger-scale, which he said increases accuracy, reliability and optimized costs.
While the financials of the deal have not been disclosed, Hoare said the arrangement ensures both organizations benefit. “Our collective, long-term vision is to develop flexible and innovative facilities while reducing costs and making drugs accessible.”
The single vendor model will deliver a “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,” Renaud Bessière, director of the Bio-S Project at Servier, said in a statement.
This model is not new for Pall, Hoare said, but “what is new here is that it is applicable for the full lines from A to Z in single use technologies.”
He continued: “So, our structure is already in place, well-trained and able to offer a quick and best in class support to all Servier R&D projects, both in house or at their partner’s facility.
“If needed, Pall offers Servier process development capabilities to develop, optimize and validate a full process in our lab. This is one option to speed up the development process by sharing experience on the customer’s cell line and our technology platform for mAbs, recombinant proteins and cell therapies.”