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. 2001 Jul;36(1-3):33–39. doi: 10.1023/A:1014045104525

Advanced Granulation Technology (AGTTM). An alternate format for serum-free, chemically-defined and protein-free cell culture media

Richard Fike 1, Barbara Dadey 1, Richard Hassett 1, Robert Radominski 1, David Jayme 2,✉, David Cady 1
PMCID: PMC3449658  PMID: 19003312

Abstract

To overcome limitations of conventional milling technology, we investigated the application of fluid bed granulation for the production of dry-form nutrient media. Serum-free, protein-free and chemically-defined specialty media were produced in granulated format and compared with identical formulations manufactured by conventional methods. HPLC analysis of multiple lots of granulated materials demonstrated that biochemical constituents were precisely and homogeneously distributed throughout the granules and that nutrient levels were comparable to conventional formats. Comparison of medium performance in cell proliferation and biological production assays demonstrated equivalence with reference media. The fluid bed granulation process meets pharmaceutical quality requirements and may be applied to a broad range of nutrient formulations required for bioproduction applications.

Keywords: biopharmaceutical production, complete formulation, granulated media, novel format, nutrient media, protein-free, serum-free

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