Lonza's Purification Development team has extensive experience in the development and validation of purification processes for the large-scale manufacture of a wide range of therapeutic proteins. These include recombinant monoclonal antibodies, antibody fragments, fusion proteins and chemically conjugated proteins, hormones, enzymes and other proteins. To ensure the development of an integrated process, and to minimize the development timeline, purification development activities are performed in parallel with fermentation and assay development activities. A target specification for the product is first defined with the customer. Concurrently, fermentation, product recovery and purification processes are developed to meet this specification.
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Recombinant Protein Purification
Lonza’s purification development group has developed purification processes for a wide variety of recombinant proteins. Many of these process development projects are undertaken in collaboration with the customer’s process development and analytical scientists. A wide range of chromatographic operations have been used for the purification of recombinant proteins (e.g. ion exchange, hydrophobic interaction, affinity, ceramic Hydroxyapatite, metal chelate, gel permeation, etc.). Virus removal and virus inactivation steps are included in all processes, and particular attention is paid to the characterization of post-translational modifications such as glycosylation.