Endotoxin reduction in monoclonal antibody preparations using arginine

Area of Science:

• Biochemistry
• Protein purification
• Immunology

Background:

• Endotoxin contamination poses a significant challenge in monoclonal antibody (mAb) production.
• Conventional endotoxin removal methods often fail when endotoxins are closely associated with antibodies.

Purpose of the Study:

• To evaluate methods for endotoxin removal from mAb preparations.
• To identify efficient and scalable techniques for dissociating and removing endotoxins associated with antibodies.

Main Methods:

• Immobilization of mAbs onto chromatographic media.
• Introduction of buffer additives in the mobile phase to dissociate endotoxins.
• Evaluation of non-ionic detergents and arginine as buffer additives.

Main Results:

• 0.5M arginine demonstrated comparable endotoxin removal efficiency to non-ionic detergents.
• Arginine successfully reduced endotoxin levels to less than 0.2 EU mg(-1).
• Monoclonal antibody recovery exceeded 95% using the arginine-based method.

Conclusions:

• Arginine is an effective, non-toxic, and easily removable additive for endotoxin removal during mAb purification.
• The developed method is easily integrated into existing purification processes, offering speed, cost, and effort advantages.
• This approach provides a scalable solution for producing endotoxin-free monoclonal antibodies.