Method of Non-Chromatographic Purification of Monoclonal Antibodies
The potent pharmacodynamics and numerous diagnostics of monoclonal antibodies (mAbs) have led to their extensive use as therapeutic treatments for various cancers and autoimmune disorders, and for diagnostic assays. However, rapid developments in the foundational cell biology and recombinant technology of mAbs have not been matched by progress in downstream purification, a major determinant of mAb cost. mAb purification, largely reliant on chromatography (e.g. Protein A chromatography), is the principal determinant of drug cost. The present invention generally relates to non-chromatographic purification of mAbs, and particularly, to a method of purification of monoclonal antibodies via selective coacervation with hyaluronic acid. The method separates mAb from unwanted proteins and nucleic acids secreted from mAb-producing hybridoma cells, forming a fluid coacervate from which the mAb is purified. This promising technique may be an effective alternative for Protein A chromatography. Figure (above right) demonstrates that pH and salt conditions can be optimized to achieve a 96% yield of mAb in coacervate, while only 2-10% of BSA (host cell protein).TECHNOLOGY DESCRIPTION ADVANTAGES • Economizes mAb production APPLICATIONS• New non-chromatographic method for mAb production ABOUT THE INVENTORDr. Paul Dubin is a Professor in the Department of Chemistry at the University of Massachusetts. AVAILABILITY: Available for Licensing and/or Sponsored Research DOCKET: UMA 15-027 PATENT STATUS: Patent Pending NON-CONFIDENTIAL INVENTION DISCLOSURE LEAD INVENTOR: Paul Dubin, Ph.D. CONTACT: The potent pharmacodynamics and numerous diagnostics of monoclonal antibodies (mAbs) have led to their extensive use as therapeutic treatments for various cancers and autoimmune disorders, and for diagnostic assays. However, rapid developments in the foundational cell biology and recombinant technology of mAbs have not been matched by progress in downstream purification, a major determinant of mAb cost. mAb purification, largely reliant on chromatography (e.g. Protein A chromatography), is the principal determinant of drug cost. The present invention generally relates to non-chromatographic purification of mAbs, and particularly, to a method of purification of monoclonal antibodies via selective coacervation with hyaluronic acid. The method separates mAb from unwanted proteins and nucleic acids secreted from mAb-producing hybridoma cells, forming a fluid coacervate from which the mAb is purified. This promising technique may be an effective alternative for Protein A chromatography.
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