Supplementary Figure 5: Typical product-related variant levels in reference standards for hGH, IFNα-2b and G-CSF.
From: On-demand manufacturing of clinical-quality biopharmaceuticals
Summary of product-related variant levels found in reference standards for hGH, IFNα-2b, and G-CSF compared with values found for marketed products in literature44-47. hGH and G-CSF reference standards are de-identified marketed products; IFNα-2b reference standard is a manufactured drug substance.
References
44. Jiang, H., Wu, S., Karger, B. L. & Hancock, W. S. Mass Spectrometric Analysis of Innovator, Counterfeit, and Follow-On Recombinant Human Growth Hormone. Artif. Cells Blood Substitutes Immobil. Biotechnol. Cells Blood Substit Immobi 10–15 (2009). doi:10.1021/bp.72
45. Riggin, R. M., Shaar, C. J., Dorulla, G. K., Lefeber, D. S. & Miner, D. J. High-performance size-exclusion chromatographic determination of the potency of biosynthetic human growth hormone products. J. Chromatogr. A 435, 307–318 (1988).
46. Herman, A. C., Boone, T. C. & Lu, H. S. Characterization, Formulation, and Stability of Neupogen(R) (Filgrastim), a Recombinant Human Granulocyte-Colony Stimulating Factor. in Formulation, Characterization, and Stability of Protein Drugs (eds. Pearlman, R. & Wang, Y. J.) 303–328 (Plenum Press, 1991). doi:10.1080/10643389.2012.728825
47. Rathore, A. S. & Bhambure, R. Establishing analytical comparability for ‘biosimilars’: Filgrastim as a case study. Anal. Bioanal. Chem. 406, 6569–6576 (2014).
