Sartorius #1 eBook - 2019 - 9

Sample Preparation for Quality Control

Conclusion
The novel Claristep® filtration device was easy to use and
facilitated a rapid sample preparation. Protein losses were
negligible compared to the standard sample preparation protocol if protein concentrations were 1.0 g L-1. If
applicable, a pre-adsorption of the filter with a defined
non-analyte protein (e.g. bovine serum albumin) may reduce
the protein losses that we observed for mAb concentrations
below 1.0 g L-1 and can thus render the method compatible with analytical methods that typically require only low
concentrations of the target molecule, e.g. surface plasmon
resonance. n
References
1. Interferon alfa-2 concentrated solution. European
Pharmacopoeia. 8.3: p. 2502-2505.
Abbreviations
df
Degrees of freedom
EDTA
Ethylene diamine tetraacetic acid
HPLC
High performance liquid chromatography
mAb
Monoclonal antibody
TFA
Trifluoroacetic acid
p-value Probability value
t-test Student's t-test
Tris
2-Amino-2-(hydroxymethyl)propane-1,3-diol
(U)HPLC (Ultra-) high performance liquid chromatography

9

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Sartorius #1 eBook - 2019

Table of Contents for the Digital Edition of Sartorius #1 eBook - 2019