Biomedical Engineering Reference
In-Depth Information
DNA filtration & viral filtration
Harvest
fluid
Formulation
TFF
Chromatographic
column
Chromatographic
column
Chromatographic
column
Eluate
Eluate
Eluate
Formulated
bulk drug
substance
Harvest fluid that has been filtered and pH adjusted can be loaded onto chromatographic columns (e.g., ion exchange
columns - IEC) for initial purification. In the next step, the eluate is loaded onto chromatographic columns (e.g., IEC, affinity, etc.)
for intermediate processing and removal of contaminants (e.g., viruses). Intermediate processed eluates are then loaded onto
chromatographic columns (e.g., GPC, high resolution adsorption chromatography) for a final polishing and concentration step for
removal of contaminants and impurities.
Figure 12.7 Typical stages in the recovery and purification of extracellular therapeutic products.
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