In today’s market, mAbs are produced for several therapeutic applications, yet they are not a homogeneous family of products. Each mAb is unique, based on its isoelectric point, hydrophobicity and ability to aggregate; the contaminant HCP content is also process-dependent.
As drug manufacturers seek to produce mAbs for various application, they are also looking to streamline processes for efficiency and quality. Till now, mAb purification processes have traditionally acted as a barrier to innovation due to:
- The long screening and optimization process development of each mAb process limiting changes of existing processes
- The non universality of the mAb process solution to reply to each mAb specificity
- Low capacity of mixed mode chromatography sorbents which limited their use in despite of their unrivalled resolution
Pall Biotech recently delivered a solution to biopharmaceutical manufacturers who are looking to optimize their own mAb purification processes: CMM HyperCel™ mixed-mode cation exchange sorbent. This high-performance, salt-tolerant, mixed-mode cation sorbent combines the selectivity power of a mixed-mode sorbent and the high binding capacity of a cation exchanger.
CMM HyperCel sorbent is a mixed-mode product with aminobenzoic acid ligand properties that confer cation exchange properties via the carboxyl group, and hydrophobicity through its aromatic ring. CMM HyperCel sorbent enables the separation of the target molecule from physically similar contaminants. Additionally, it has been proven to bind mAbs over a broad range of conductivity and pH, and is able to be integrated into new or existing processes with no need to adjust the load buffer condition, thereby eliminating dilution/diafiltration steps.
In a recent white paper, Method for Optimizing mAb Polishing Using CMM HyperCel Mixed-Mode Cation Exchanger, the team detailed the development of a polishing step for post Protein A monoclonal antibody (mAb) using CMM HyperCel mixed-mode cation exchange sorbent.
The paper delivers critical takeaways, including how:
- High throughput chromatography screening was completed with minimal sample consumption
- Design space operation was refined
- Efficient host cell proteins (HCPs) and aggregate removal was achieved (and how it can be done over a broad range of conditions)
It is also critical to note that the paper details how the CMM HyperCel polishing step can be optimized in the last step in a mAb purification process with KANEKA KanCapA™ Protein A sorbent as a capture step, and Mustang® Q membrane in flow through mode. The optimization comes from the complementary nature of the sorbent to the impurity removal performance of CMM HyperCel sorbent.
For more information, please see application note USD 3189