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The Purification Development team has extensive experience in the development, characterization and validation of purification processes of a wide range of therapeutic proteins. These include recombinant monoclonal antibodies, chemically conjugated proteins, hormones, enzymes and other proteins. We have developed purification processes for more than 15 recombinant proteins.
To ensure the development of an integrated process, and to minimize the timeline, purification development activities are performed in parallel with fermentation and analytical assay development activities. Downstream process lab has resin library with a wide range of chromatographic resins used for the purification of recombinant proteins (e.g. Affinity, Ion exchange, Hydrophobic interaction, Mixed mode, Gel Filtration, etc.). Virus removal and virus inactivation steps are included in mammalian cell culture derived processes, and particular attention is paid to the characterization of post-translational modifications such as glycosylation. During process development, importance is given for decreasing production costs and improving robustness using advanced technologies.
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