Unchained Labs eBook - 26

Unleash your biologic * Kick manual buffer exchange to the curb

control, and flexibility in the degree of exchange for each cycle,
which reduces the possibility of aggregation at high protein
concentrations.

Case studies
A mAb excipient screen was run on the Junior buffer exchange
system. The molecule starting stock was 25 mg/mL, and was
concentrated to a final target of 60 mg/mL post-exchange.
Formulations spanned a pH range of 6.3-7.4 in 0.1 increments,
with no excipient, sodium chloride, sucrose, or arginine. In all,
48 unique formulations were exchanged in duplicate.
The experiment took only 30 minutes of hands-on time to transfer
the protein into the Unfilter and place it onto the Junior buffer
exchange deck. Exchange was completed in 7 hours. Immediately
following exchange, concentration and mass recovery were analyzed
for each sample. Concentration for the samples ranged from 57-78
mg/mL and high mass recoveries were evident throughout the
experiment, ranging from 89-99% (Figure 4 and Figure 5).
A mAb pH screen was run on Grunt. Similar to the previous study
on Junior, the starting molecule stock concentration of 25 mg/mL
was brought to a final concentration of 60 mg/mL. The antibody
was exchanged into acetate, histidine and phosphate buffers in
a 4-8 pH range.
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Figure 5.
Mass recovery for each protein formulation measured after
Junior buffer exchange.
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