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Method of Non-Chromatographic Purification of Monoclonal Antibodies

详细技术说明

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.

*Abstract

None

*Principal Investigation

Name: Paul Dubin

Department: Chemistry

Name: Rachel Wollacott, R&D Scientist II

Department: MassBiologics

Name: Daniel Seeman, PhD Candidate

Department: Chemistry

Name: Alex Malanowski, Undergraduate

Department: Chemistry

国家/地区

美国