Antibody fragments constitute a promising class of biopharmaceutical products. As compared with full length antibodies, their fragments have unique properties that make them favorable for certain therapeutic conditions. However, due to their high molecular diversity, the use of a purification platform approach (i.e., standard sets of unit operations, conditions, and methods applied to a given class of molecules) is more difficult for fragments than for full length antibodies, for which the Fc region can be utilized as a common binding motif. However, with recent developments of novel affinity chromatography resins, there are new emerging possibilities. Here, we present affinity chromatography resins that offer the possibility of a platform approach to the purification of the majority of antibody fragments. The described BioProcess™ resins offer high selectivity and excellent pressure-flow properties for high purity and yield in industrial-scale purifications. In addition, several case studies on purification of antibody fragments are described.
November 10, 2016