ProteinSimple eBook - 21

Simplifying Protein Analysis * Comparability Study of Manual and Automated Particle Characterization with MFI

Comparison of the Manual Versus Automated Method, Takeda
Tests performed at Takeda were comparable to the ProteinSimple site, and the
automated format of 1% BSA protein solution produced consistent counts and
concentration data similar to the manual format (data not shown). The standard
deviation for both methods was 6% or less for all samples tested. Takeda results
were similar to ProteinSimple's in terms of successful transfer of the 1% BSA
assay to an automated format.
Conclusion
The MFI 5200 produces the same high-quality particle characterization in manual
or automated mode. This study showed that method optimization could further
reduce the sample volume required without impairing concentration accuracy.
Statistical analysis conﬁrmed that these protocols are robust and provide an
example of standardization of methods across instrument conﬁgurations.
In the Takeda development laboratory, MFI was originally implemented due
to its advantages over conventional techniques (HIAC-based light obscuration
used according to Ph. Eur. 2.9.20/USP <788>) for measurement of sub-visible
particles in the µm range (e.g. 2-10 µm).

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Those advantages included:
* Lower sample consumption versus light obscuration
* 1-10 µm particle detection
* MFI's ability to distinguish between particle types
based on morphology parameters
Reduction of hands-on time associated with manual operation was a primary
goal, and became the main reason for upgrading to the automated MFI 5200 system
with Bot1autosampler at an early stage. In addition, the improved reproducibility
associated with the automated format further contributed to the decision to
upgrade. The option to automate provides a key advantage for particle
characterization of protein formulations, offering many beneﬁts compared to
more common techniques. Automated protocols allow for much greater
throughput and less hands-on time, with up to 90 samples per unattended run,
and address demand for more rapid and consistent screening methods in particle
characterization. Moreover, the latest version of MFI's MVSS analysis software
give you high throughput with the full beneﬁts of multisample analysis. It's ideal
for monitoring the impact of different conditions during stability testing. For
more information on the new multisample analysis format, be sure to check
the link to the Appendix section on the next page. n

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