Unchained Labs eBook - 30

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Case study
In this study, we used a Freeslate system to complete a protein
formulation screening and stability study. To demonstrate the
productivity improvements made possible with the Freeslate
system, we automated the buffer and excipient screen, and the
stressing and analysis of each sample (Figure 2). Protein drug
products in multiple formulations were previously tested by a set of
physical and thermal stress tests, and then studied for evidence
of degradation. These manual stress tests included agitation or
stirring the samples at different temperatures, for different times,
in different reaction vessels. The measurements for degradation
included DLS, UV/Vis, and SEC (Figure 2).

For the Freeslate, we added the capabilities of making the
formulations within the automated workflow. The system could
automate the heating, stirring and measurements from the manual
methods. The rotation method used in the manual method was
matched to a vortex method that could be automated. For the analysis,
we added inline turbidity, particle counting and color measurements
on vialed samples, which could be measured without removing the
sample from the vial. SEC was performed offline, but samples for SEC
were prepared on the Freeslate. While the Freeslate as configured can
do the entire soup-to-nuts formulation creation and assessment, the
workflow could be split into two smaller Freeslate Junior automated
platforms. The processing data from both systems plus the offline
SEC data can be linked together with the LEA software package.

Figure 2.
Formulation study design. Two protein drug molecules were formulated, stressed and analyzed by a traditional manual or an automated process.

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