Protein isolated from biopharmaceutical formulations cannot be used for comparative studies: Follow‐up to “a case study using Epoetin Alfa from Epogen and EPREX”

In the biotechnology area, the issue of comparability with an innovator product is complex. Ideally, a side‐by‐side comparison of physical properties would be part of the demonstration of comparability. However, biogeneric companies do not have access to the bulk drug substance from the innovator co...

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Bibliographic Details
Published in:Journal of pharmaceutical sciences 2007-12, Vol.96 (12), p.3214-3225
Main Authors: Heavner, G.A., Arakawa, T., Philo, J.S., Calmann, M.A., LaBrenz, S.
Format: Article
Language:English
Subjects:
analytical ultracentrifugation
Biological and medical sciences
biophysical characterization
biosimilar
Chemistry, Pharmaceutical
Chromatography, High Pressure Liquid
Drug Compounding
Drug Contamination
Drug Stability
Epoetin Alfa
Epogen
EPREX
Erythropoietin - chemistry
Erythropoietin - isolation & purification
General pharmacology
Hematinics - chemistry
Hematinics - isolation & purification
Hydrogen-Ion Concentration
Medical sciences
Pharmaceutical technology. Pharmaceutical industry
Pharmacology. Drug treatments
Protein Denaturation
protein isolation
Quality Control
Recombinant Proteins
Reproducibility of Results
Spectrophotometry, Ultraviolet
Technology, Pharmaceutical - methods
Technology, Pharmaceutical - standards
Ultracentrifugation
ultraviolet spectroscopy
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Summary:In the biotechnology area, the issue of comparability with an innovator product is complex. Ideally, a side‐by‐side comparison of physical properties would be part of the demonstration of comparability. However, biogeneric companies do not have access to the bulk drug substance from the innovator company for biophysical comparison, and isolation of protein from marketed product cannot be guaranteed to produce material that is identical to the bulk drug substance from which it was prepared. In a recently published study, protein was isolated from marketed product and comparative studies performed. In a follow‐up investigation of the published work, we demonstrate here that even a simple isolation procedure can significantly compromise the protein, which raises serious questions about the interpretation of that study, and in a broader context the value of any studies done with such “out‐of‐process” protein. © 2007 Wiley‐Liss, Inc. and the American Pharmacists Association J Pharm Sci 96: 3214–3225, 2007
ISSN:0022-3549
1520-6017
DOI:10.1002/jps.20993