FUJIFILM Biotechnologies

Articles by FUJIFILM Biotechnologies

Microbial cell culture processes are diverse and difficult to harmonize, however, with a new microbial purification platform, downstream processes are streamlined. Applicable for use in E. coli and P. pastoris, this microbial purification platform utilizes a novel scarless protease to reduce purification steps, accelerating the journey from PD to GMP.

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Case study showcasing accelerated PPQ for an E. coli–expressed orphan therapy, achieving three PPQ batches in 18 months through high-compliance manufacturing.

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This white paper explains the benefits and challenges of microbial-based fermentation for biologics, highlighting why processes often need to be custom-built for each molecule. Outlining a streamlined, cost-effective path that accelerates development from strain selection through tox material and early GMP, to reach IND and first-in-human trials faster.

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