Resolving 5 Challenges Of Novel mAb Purification

The growing diversity of monoclonal antibody (mAb) therapies presents new purification challenges that conventional chromatography techniques, like Protein A, may struggle to address. Thermo Fisher Scientific offers CaptureSelect™ affinity ligands and POROS™ chromatography resins to overcome these issues, enabling efficient, scalable mAb purification with high yield and purity.

Key Challenges in Novel mAb Purification:

• Absence or modification of the Fc region, impairing affinity binding.
• pH-sensitive mAbs, limiting interactions with polishing matrices.
• Aggregates, dimers, and mixed molecular weight species in the culture medium.
• Overexpressed light chains and light chain dimers competing for binding.
• Sensitivity to elution conditions, impacting stability.

CaptureSelect™ & POROS™ Solutions:
CaptureSelect™ ligands specifically target challenging mAb structures where Protein A fails, enabling effective purification of bi-specific antibodies, Fab fragments, and Fc-fusion proteins. POROS™ beads facilitate hydrophobic interaction (HIC), ion exchange (IEX), and multimodal chromatography for removing host cell proteins, aggregates, DNA, and virus particles.

Advantages:

• High specificity for complex mAb isoforms.
• Chemically robust, scalable purification platforms.
• Tailored solutions for streamlined bioprocessing.

These innovations support next-generation mAb therapies to help meet rigorous production and quality standards, accelerating their path to clinical and commercial success.

_{Pharmaceutical Grade Reagent. For Manufacturing and Laboratory Use Only.}