Process development

LFB BIOMANUFACTURING offers its development services for your pharmaceutical biomedicine projects at the pre-clinical and clinical stages: development of cell lines and cell banks, and development of processes at industrial scale.

Our customers include both pharmaceutical and biotechnology companies, and, for you too, we offer tailor-made support throughout your biopharmaceutical project.
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Development of industrial-scale processes

CELL CULTURE AND PURIFICATION PROCESSES

The biomedicinal product manufacturing processes developed must be transposable to industrial scale in order to obtain a competitive product on the market. To address this challenge, we use cell lines specially adapted to serum-free/protein-free media, optimised to achieve optimal yield.
We develop the cell culture processes (Upstream process = USP) and purification processes (Downstream process = DSP), commonly called USP DSP, in state-of-the-art facilities. Our upstream process development workshops work in particular with micro ambr® 15 and ambr® 250 bioreactor systems to optimise the media and culture parameters, and then move to single-use bioreactors for the industrial scale-up.

Our CDMO experience with complex processes and industrialisations

Our biomanufacturing specialists team up with the LFB Group’s network of experts to facilitate the development of optimal cell culture conditions for each line. Our engineering teams have extensive experience in selecting the most suitable chromatography and filtration processes and associated viral elimination methods.
We have successfully developed numerous molecules and cell line processes, up to industrial scale, and today we are able to produce recombinant proteins and monoclonal antibodies under optimal conditions:
♦ Development of cell culture processes,
♦ Optimisation of media and yields,
♦ Preparation of media,
♦ Full development of processes from A to Z (USP DSP),
♦ Production of 50 L batches (non-GMP) in the pilot zone, and batches up to 2000 L in one of its 3 multi-product production zones. Additional capacities are under construction.

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