High binding capacity for bispecific antibodies and antibody fragments containing the VH3 sequence family. Provides good resolution for productrelated impurities in the capture of bispecific antibodies. Excellent alkaline stability; stable when cleaned with 0.5 M NaOH, minimizing risk for bioburden incidents and providing a long resin lifetime. A single interaction with the Fab VH3 region is beneficial over a dualinteraction affinity ligand, as separation of unwanted mispaired antibodies and fragments from target bsAb may be more efficient. Prepacked column with MabSelect™ VH3 resin. This protein A ligand interacts only with the variable heavy chain of the VH3 sequence family of the human antibody for efficient separation of bispecific antibodies (bsAb) and fragments, such as fragment antigenbinding region (Fab), singlechain variable fragment (scFv), and variable heavy domain of heavy chain (VHH). Engineered for specific VH3 interaction The ligand of MabSelect™ VH3 resin has been engineered to have affinity only for the variable region of the VH3 heavy chain. Traditional protein A resins have affinity for both the Fc region and the Fab VH3 region of human antibodies. In the ligand used in the MabSelect™ VH3 resin, the Fc interaction has been knocked out, and VH3 interaction has been enhanced. In bioprocessing, an affinity ligand with a single interaction with the Fab VH3 region is beneficial over a dualinteraction affinity ligand, as separation of unwanted mispaired antibodies and fragments from the target bispecific antibody (bsAb) may be more efficient. The VH3 sequence family is the most common VH class for antibodies in commercialized biologics. Efficient separation of bsAb and antibody fragments High dynamic binding capacity (DBC) allows high mass throughput of processed antibody per resin volume unit. It also provides productivity and process economy benefits. For a typical mAb (with VH3 sequence), MabSelect™ VH3 resin shows similar binding capacity as MabSelect PrismA™ resin. MabSelect VH3 resin showed significantly higher (70%) binding capacity for Fab compared to MabSelect PrismA™ resin. For VHH, MabSelect™ VH3 resin showed a higher (11%–14%) DBC compared to MabSelect PrismA™ resin.
Asymmetric bispecific antibodies can form productrelated impurities such as homodimers, half antibodies, and an excess of light chains during cell culture. They are also prone to aggregation. The similarities between these impurities present extra challenges for downstream processes, especially postcapture. MabSelect™ VH3 resin and its novel selectivity enables separation in the capture step of asymmetric bispecific antibodies, where only one of the heavy chains includes the VH3 sequence family, from productrelated entities. Robust resin designed for harsh cleaning over many cycles The alkaline stability of the MabSelect™ VH3 resin was evaluated in an accelerated alkaline stability study and in a repeated CIP cycling study with 0.5 M NaOH. The resin showed excellent alkaline stability when cleaned with 0.5 M NaOH. Resin toolbox for the diversified antibody pipeline Manufacturing platform approaches used for many traditional monoclonal antibodies (mAbs) are being adapted to fit respective antibody variant molecules. To provide the required purity and yield, a chromatography resin must be selected based on the domains of the target molecule, the impurity profile, and the antibody regions that the resin interacts with.
