Unchained Labs eBook - 31

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For this case study, molecule and formulation stability were assessed
by the manual method, establishing benchmarks for expected data
prior to running the automated method. For molecule 1, formulation
stability was determined to be B > C > A. For molecule 2, formulation
stability was assessed to be C > B/B' > A. Formulations were run manually in 2 mL vials. That format was also tested on the Freeslate. To seek
out additional benefits, the formulations were also plated in a 96-well
plate to determine if similar results could be obtained in that format.
Control samples were created and assessed for formulation.
Data from the study confirmed similar DLS and UV/Vis data between the
manual and automated process. Data from visual particle counting and
turbidity, while not part of the manual process, added to the data available for the formulation stability assessment. In larger screens, this data
could be used to differentiate formulations that otherwise appear similar.
SEC data from the various stress conditions applied to Molecule 1
exhibited the most striking distinction between the three formulation
conditions. Stirring the sample greatly reduced the % monomer
content for Formulation A and C. Formulation B retained the highest
% monomer and lowest % aggregate among the three formulations
(Figure 3).

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Figure 3.
% aggregate peak for the three formulations studied for Molecule
1. Across multiple testing conditions the average amount of
aggregate was lowest in Formulation B and worst in Formulation A.

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