Method for purifying antibodies
Inventors
Meh, David • Atolagbe, Timothy • Farquharson, G. Mark • Shaban, Samir • Koleck, Mary • Mitra, George
Assignees
United Therapeutics Corp • US Department of Health and Human Services
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Publication Number
US-12358946-B2
Publication Date
2025-07-15
Expiration Date
Abstract
Disclosed here includes a method for purifying a biologic composition, comprising diafiltering the biologic composition into a composition comprising phosphate buffered saline (PBS) to obtain a purified composition. The method disclosed here can be particularly useful for removing one or more impurities from the biologic composition, such as bis(2-hydroxyethyl)amino-tris(hydroxymethyl)methane (Bis-tris).
Core Innovation
The invention is a method for purifying a biologic composition by diafiltering the biologic composition with phosphate buffered saline (PBS). The biologic composition prior to purification comprises bis(2-hydroxyethyl) amino-tris(hydroxymethyl)methane (Bis-tris), and the diafiltering removes at least 50% of the Bis-tris to obtain a purified composition.
The method specifies that the concentration of PBS is 10 to 50 mM Sodium Phosphate and 100 to 200 mM NaCl. The core disclosure also includes defined ranges for Bis-tris in the starting composition and describes diafiltration through PBS prior to final HBS formulation.
The disclosure further describes embodiments that integrate additional purification steps, including chromatography such as affinity and ion exchange, and the use of Capto™ adhere. It also references monoclonal antibody purification context, including ch14.18/dinutuximab, and further purification steps into histidine-buffered saline (HBS).
Claims Coverage
The independent claim covers a biologic purification method with four inventive features.
Diafiltering a Bis-tris-containing biologic with PBS
A method for purifying a biologic composition, comprising diafiltering the biologic composition with phosphate buffered saline (PBS) to obtain a purified composition, wherein the biologic composition prior to purification comprises bis(2-hydroxyethyl) amino-tris(hydroxymethyl)methane (Bis-tris).
Removing at least 50% Bis-tris during diafiltration
The diafiltering removes at least 50% of the Bis-tris from the biologic composition.
PBS defined by sodium phosphate and NaCl ranges
The concentration of the PBS is 10 to 50 mM Sodium Phosphate and 100 to 200 mM NaCl.
Excluding a ch14.18 antibody from the biologic composition
Wherein the biological composition does not comprise a ch14.18 antibody.
Overall, the independent claim requires PBS diafiltration of a Bis-tris-containing biologic composition, quantitative removal of Bis-tris, use of PBS with sodium phosphate and NaCl in specified ranges, and exclusion of a ch14.18 antibody from the starting composition.
Stated Advantages
Documented Applications
Purification of a biologic composition, including a process context specifically mentioning ch14.18/dinutuximab monoclonal antibody, using diafiltration with PBS to remove Bis-tris impurities prior to final histidine-buffered saline (HBS) formulation.
Monoclonal antibody purification embodiments that integrate affinity chromatography and ion-exchange chromatography (cation exchange and/or anion exchange), including the use of a Capto™ adhere column.
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