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Development and Scale up of Preparative HIC for the Purification of a Recombinant Therapeutic Protein
Author(s) -
Graumann K.,
Ebenbichler A. A.
Publication year - 2005
Publication title -
chemical engineering and technology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.403
H-Index - 81
eISSN - 1521-4125
pISSN - 0930-7516
DOI - 10.1002/ceat.200500165
Subject(s) - process development , quality by design , downstream processing , transferability , biopharmaceutical , process optimization , scale (ratio) , context (archaeology) , biochemical engineering , robustness (evolution) , chemistry , hydrophilic interaction chromatography , scale up , process engineering , chromatography , process (computing) , computer science , downstream (manufacturing) , engineering , machine learning , high performance liquid chromatography , microbiology and biotechnology , chemical engineering , biology , biochemistry , operations management , operating system , paleontology , logit , quantum mechanics , classical mechanics , physics , gene
In the biopharmaceutical industry, process development has to overcome the paradox between increasing demands on product quality and aggressive overall development time lines. Streamlining development and scale‐up has become a requirement in order to cope with these constraints. Hydrophobic interaction chromatography (HIC) has gained popularity as an efficient tool in downstream process development, which represents an orthogonal method compared to other widely used chromatography principles. Thus, host cell protein (HCP) removal combined with the separation of product variants based on subtle differences in hydrophobicity are major strengths of this separation technique. The development and scale‐up of a preparative HIC step for a therapeutic protein for human use is described. Issues like the removal of product‐ and process‐related impurities have been addressed. The direct transferability of the results, from scale‐down optimization experiments via the pilot scale to the final production scale, clearly show the robustness and power of HIC in this process context.