Platform Purification of Six Biosimilar Molecules using Amsphere A3 – Protein A Resin

Currently more than 70 biosimilar mAbs (monoclonal antibodies) are under development and multiple originator mAbs are going off-patent in the next 3-4 years. Protein A resin remains the most important workhorse for the purification of monoclonal antibodies. Protein A resin has a high impact on both development and manufacturing cost, in particular during early stage clinical phases. This application note summarizes the key performance parameters for our high capacity protein A resin, Amsphere A3, for 6 biosimilar molecules of which five are mAbs and one is a Fc-fusion protein.

Materials and Methods
TABLE 1: MONOCLONAL ANTIBODIES AND FUSION PROTEIN—ALL BIOSIMILARS DERIVED FROM CHO CELL LINE CLARIFIED BY CENTRIFUGATION AND 0.22 MICROMETER FILTRATION

FIGURE 1: TEST CONDITIONS OF CHROMATOGRAPHY PROCESS

TABLE 2: EXPERIMENTAL METHODS AND MATERIALS

Results
FIGURE 2: PLATFORM PURIFICATION OF FIVE BIOSIMILAR ANTIBODIES USING AMSPHERE A3

TABLE 3: HCP REMOVAL

FIGURE 3: LEACHED PROTEIN A

Discussion and Conclusions
Amsphere A3 consistently delivers high binding capacities and excellent impurity clearance for multiple biosimilar molecules as highlighted in this application note. Amsphere A3 excels with comparably high DBC demonstrating its potential to improve the process economics for biosimilar development and manufacturing. In addition, the data underlines the suitability of Amsphere A3 as a platform, since the same protocol was used for all investigated mAbs, consistently yielding excellent performance results with standard wash and elution buffers.

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