LFB Biomanufacturing can offer mammalian cell line development capabilities and can work with most common recombinant mammalian cell lines such as CHO, to assist clients with cell line selection, comparability assessments and cell line characterization. Moreover, LFB Biomanufacturing can propose EMABling, a proprietary technology using the YB2/0-E cell line to produce recombinant monoclonal antibodies having an enhanced antibody-dependent cellular cytotoxicity (ADCC) activity.
Upstream (USP) and downstream process (DSP) optimizations are executed in state-of-the-art facilities using both “platform-type” and customized approaches. LFB Biomanufacturing’s technological options uses exclusively Single-Use-Technology (SUT) such as disposable bioreactors Hyclone Bioreactors (SUB) systems. Our in-house scientists and our network of experts will facilitate the development of optimum cell culture conditions for each cell line. Our engineering staff possess strong experience for the selection of optimal chromatography and filtration/purification processes and viral clearance methods. LFB Biomanufacturing has a proven track record in tackling a number of challenging processes and scale-up, resulting in successful production of several antibodies and recombinant proteins.
The GMP multi-product manufacturing facility has been produced API/DS batches since 2005. The facility has been regularly inspected and approved by the French regulatory agency (ANSM). The facility has been inspected succesfully by FDA in 2017. LFB Biomanufacturing also offers GMP mammalian cell bank production as part of a comprehensive process development and manufacturing project. Buffers and cell culture media are manufactured under GMP conditions in dedicated production suites at 2,000L scale using a state of the art single-use technology and scale-out approach up to 6x2000L
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