US20170066839A1 - Novel affinity chromatography media for removal of anti-a and/or anti-b antibodies - Google Patents

Novel affinity chromatography media for removal of anti-a and/or anti-b antibodies Download PDF

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Publication number
US20170066839A1
US20170066839A1 US15/226,461 US201615226461A US2017066839A1 US 20170066839 A1 US20170066839 A1 US 20170066839A1 US 201615226461 A US201615226461 A US 201615226461A US 2017066839 A1 US2017066839 A1 US 2017066839A1
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Prior art keywords
media
antibodies
ligand
solid support
sample
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Abandoned
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US15/226,461
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English (en)
Inventor
Nanying Bian
Chia-Yun Sun
Melissa Holstein
Kristen Cotoni
Matthew T. Stone
Santosh RAHANE
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Merck Patent GmbH
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Merck Patent GmbH
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Application filed by Merck Patent GmbH filed Critical Merck Patent GmbH
Priority to US15/226,461 priority Critical patent/US20170066839A1/en
Assigned to EMD MILLIPORE CORPORATION reassignment EMD MILLIPORE CORPORATION ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: SUN, CHIA-YUN, BIAN, NANYING, COTONI, KRISTEN, HOLSTEIN, Melissa, RAHANE, Santosh, STONE, MATTHEW T.
Assigned to MERCK PATENT GMBH reassignment MERCK PATENT GMBH ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: EMD MILLIPORE CORPORATION
Publication of US20170066839A1 publication Critical patent/US20170066839A1/en
Priority to US17/088,659 priority patent/US12441809B2/en
Abandoned legal-status Critical Current

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/34—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against blood group antigens
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, fragmentation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C07K1/22—Affinity chromatography or related techniques based upon selective absorption processes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/10—Selective adsorption, e.g. chromatography characterised by constructional or operational features
    • B01D15/20—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to the conditioning of the sorbent material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/38—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving specific interaction not covered by one or more of groups B01D15/265 and B01D15/30 - B01D15/36, e.g. affinity, ligand exchange or chiral chromatography
    • B01D15/3804—Affinity chromatography
    • B01D15/3809—Affinity chromatography of the antigen-antibody type, e.g. protein A, G or L chromatography
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/42—Selective adsorption, e.g. chromatography characterised by the development mode, e.g. by displacement or by elution
    • B01D15/424—Elution mode
    • B01D15/426—Specific type of solvent
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J20/00—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
    • B01J20/28—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof characterised by their form or physical properties
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J20/00—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
    • B01J20/28—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof characterised by their form or physical properties
    • B01J20/28014—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof characterised by their form or physical properties characterised by their form
    • B01J20/28016—Particle form
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J20/00—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
    • B01J20/281—Sorbents specially adapted for preparative, analytical or investigative chromatography
    • B01J20/282—Porous sorbents
    • B01J20/285—Porous sorbents based on polymers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J20/00—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
    • B01J20/281—Sorbents specially adapted for preparative, analytical or investigative chromatography
    • B01J20/286—Phases chemically bonded to a substrate, e.g. to silica or to polymers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J20/00—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
    • B01J20/281—Sorbents specially adapted for preparative, analytical or investigative chromatography
    • B01J20/286—Phases chemically bonded to a substrate, e.g. to silica or to polymers
    • B01J20/289—Phases chemically bonded to a substrate, e.g. to silica or to polymers bonded via a spacer
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J20/00—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
    • B01J20/30—Processes for preparing, regenerating, or reactivating
    • B01J20/32—Impregnating or coating ; Solid sorbent compositions obtained from processes involving impregnating or coating
    • B01J20/3202—Impregnating or coating ; Solid sorbent compositions obtained from processes involving impregnating or coating characterised by the carrier, support or substrate used for impregnation or coating
    • B01J20/3206—Organic carriers, supports or substrates
    • B01J20/3208—Polymeric carriers, supports or substrates
    • B01J20/321—Polymeric carriers, supports or substrates consisting of a polymer obtained by reactions involving only carbon to carbon unsaturated bonds
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J20/00—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
    • B01J20/30—Processes for preparing, regenerating, or reactivating
    • B01J20/32—Impregnating or coating ; Solid sorbent compositions obtained from processes involving impregnating or coating
    • B01J20/3231—Impregnating or coating ; Solid sorbent compositions obtained from processes involving impregnating or coating characterised by the coating or impregnating layer
    • B01J20/3242—Layers with a functional group, e.g. an affinity material, a ligand, a reactant or a complexing group
    • B01J20/3268—Macromolecular compounds
    • B01J20/3272—Polymers obtained by reactions otherwise than involving only carbon to carbon unsaturated bonds
    • B01J20/3274—Proteins, nucleic acids, polysaccharides, antibodies or antigens
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J2220/00—Aspects relating to sorbent materials
    • B01J2220/50—Aspects relating to the use of sorbent or filter aid materials
    • B01J2220/54—Sorbents specially adapted for analytical or investigative chromatography
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J2220/00—Aspects relating to sorbent materials
    • B01J2220/50—Aspects relating to the use of sorbent or filter aid materials
    • B01J2220/58—Use in a single column
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen

Definitions

  • a chromatography media for removing anti-A antibodies from a sample comprising a solid support with a blood group A antigen ligand attached thereto, where the ligand is attached to the solid support at a ligand loading of at least 0.8 mg/ml of solid support, where the chromatography media is stable under acid and alkaline conditions.
  • the ligand loading is at least 1 mg/ml of solid support or at least 1.5 mg/ml of solid support or at least 1.65 mg/ml of solid support and where the chromatography media is stable under acid and alkaline conditions.
  • the chromatography media is packed in a device, e.g., a chromatography column.
  • the static binding capacity of a particular chromatography media is generally influenced by the composition of the protein solution including one or more of the following factors, e.g., concentration of the protein, amount of chromatographic media used, concentration of other components in the solution (salts, organic molecules, buffers), the solution pH, and conductivity. It may also be influenced by the temperature of the protein solution. All of these variables are generally held constant in order to allow the comparison of static binding capacity between two different chromatography media.
  • the term “static binding capacity” may also be referred to as “saturation binding capacity” or “maximum binding capacity.”
  • IgM immunoglobulin M
  • IgM antibodies refers to antibodies with a pentameric structure, e.g., the IgM antibodies found in blood serum. With a molecular weight of approximately 970 kDa, IgM antibodies are considerable larger than IgG that have a monomeric structure and a molecular weight of approximately 150 kDa. Unlike IgG antibodies that have 2 antigen binding sites, IgM antibodies have 10 antigen binding sites. IgM antibodies are primarily responsible for the agglutination of red blood cells when a recipient receives a blood transfusion from an incompatible donor. For instance, a person with blood type A and having anti-B IgM antibodies will experience agglutination upon transfusion from a blood type B donor. The large IgM antibodies can generally be separated from smaller IgG antibodies in blood plasma by fractionation.
  • a solution comprising phosphoric acid, acetic acid and benzyl alcohol (PAB) is used for sanitization.
  • PAB benzyl alcohol
  • the chromatography media described herein maintain their binding capacity or the ability to remove substantial amount of anti-A and/or anti-B antibodies even after sanitization with PAB.
  • Blood group A or B antigen antibody (anti-A/B) levels were determined using an established flow cytometry method (Christensson, M. et al, Transfusion, 1996; 36:500-505).
  • Type A or Type B red blood cells were incubated with a representative IVIG feed for a pre-determined time, followed by extensive washes. The cells were then stained with fluorescence-labeled anti-human IgGs, and subjected to Flow Cytometry (Guava 5HT, EMD Millipore).
  • the chromatography media containing trisaccharide A or trisaccharide B ligand maintain their ability to remove anti-A and anti-B antibodies, respectively, after exposure to PAB. No significant change in anti-A or anti-B removal capabilities was observed relative to a control sample which was not exposed to PAB (indicated by “0 hours” of PAB exposure in the table below).
  • For Feed 1 about 80% or higher of anti-A or anti-B antibodies were removed both in case of control and following exposure to PAB.
  • For Feed 2 about 90% of anti-A or anti-B was removed both in case of control and following exposure to PAB.
  • Trisaccharide A and Trisaccharide B Ligand Containing Media are Stable Under Acidic Conditions
  • an IVIG feed material was first passed through a column containing a trisaccharide A ligand containing chromatography media followed by a separate column containing a trisaccharide B ligand chromatography media.
  • the removal of anti-A and anti-B antibodies was determined using flow cytometry.
  • the opposite order was also demonstrated, where the feed was contacted with chromatography media containing a trisaccharide B ligand first, followed by a chromatography media containing a trisaccharide A ligand.
  • Anti-A Antigen murine monoclonal IgM antibody
  • clone BIRMA-1 Vox Sang., 1991, 61: 53-58
  • 10 mM PBS buffer product number: JH-1L-BK, EMD Millipore, Billerica, Mass., USA
  • the anti-A cell culture feed was filtered through a 0.22 micron membrane and subjected to bind/elute chromatography on a media having blood group A antigen trisaccharide (TriA) ligands attached thereto, as described herein.
  • TriA antigen trisaccharide
  • a column 10 mm in diameter was packed to 64 mm with the Tri-A ligand media.
  • the column was equilibrated with 10 mM PBS buffer (10 column volumes (CVs) at 305.58 cm/h, 4.0 mL/min) and subsequently loaded with the clarified cell culture feed containing anti-A in 10 mM PBS (40 CVs, 229.18 cm/h, 3.0 mL/min).
  • the column was washed with 10 mM PBS buffer (5 CVs, 305.58 cm/h, 4.0 mL/min), followed by 0.5 M sodium chloride in 10 mM PBS buffer (10 CVs, 305.58 cm/h, 4.0 mL/min).

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  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Hematology (AREA)
  • Peptides Or Proteins (AREA)
  • Treatment Of Liquids With Adsorbents In General (AREA)
US15/226,461 2015-09-08 2016-08-02 Novel affinity chromatography media for removal of anti-a and/or anti-b antibodies Abandoned US20170066839A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US15/226,461 US20170066839A1 (en) 2015-09-08 2016-08-02 Novel affinity chromatography media for removal of anti-a and/or anti-b antibodies
US17/088,659 US12441809B2 (en) 2015-09-08 2020-11-04 Affinity chromatography media for removal of anti-a and/or anti-b antibodies

Applications Claiming Priority (2)

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US201562215401P 2015-09-08 2015-09-08
US15/226,461 US20170066839A1 (en) 2015-09-08 2016-08-02 Novel affinity chromatography media for removal of anti-a and/or anti-b antibodies

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US17/088,659 Continuation US12441809B2 (en) 2015-09-08 2020-11-04 Affinity chromatography media for removal of anti-a and/or anti-b antibodies

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US20170066839A1 true US20170066839A1 (en) 2017-03-09

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US17/088,659 Active 2039-10-27 US12441809B2 (en) 2015-09-08 2020-11-04 Affinity chromatography media for removal of anti-a and/or anti-b antibodies

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US (2) US20170066839A1 (fr)
EP (1) EP3141558B2 (fr)
JP (1) JP6494572B2 (fr)
KR (1) KR101952228B1 (fr)
CN (1) CN106995496B (fr)
AU (1) AU2016219569B2 (fr)
CA (1) CA2938544C (fr)
ES (1) ES2737731T5 (fr)
SG (1) SG10201606493XA (fr)

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US20180345250A1 (en) * 2015-05-06 2018-12-06 Elicityl Method for the purification of whole blood or a blood-derived product
US20180345249A1 (en) * 2015-05-06 2018-12-06 Elicityl Substrate for the purification of biological liquids
WO2020154038A1 (fr) * 2018-12-05 2020-07-30 Cytosorbents Corporation Absorbants à base de polysaccharide réticulé d'élimination d'anticorps anti-a et/ou anti-b de plasma humain et de sang total
CN116868059A (zh) * 2022-10-18 2023-10-10 天津德祥生物技术股份有限公司 血型抗原三糖偶联物在血型抗体检测中的应用
US12441809B2 (en) 2015-09-08 2025-10-14 Merck Patent Gmbh Affinity chromatography media for removal of anti-a and/or anti-b antibodies

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JP7786876B2 (ja) * 2017-12-21 2025-12-16 ジェンザイム・コーポレーション プロテインａクロマトグラフィー中の不純物の除去を促進する方法
CN108101981B (zh) * 2018-01-15 2019-06-04 四川远大蜀阳药业有限责任公司 一种静注免疫球蛋白的生产工艺
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PH12022552347A1 (en) * 2020-03-06 2024-01-29 Incyte Corp Combination therapy comprising axl/mer and pd-1/pd-l1 inhibitors
CN112794425B (zh) * 2021-02-05 2022-02-18 广东省科学院生物工程研究所 一种提高右旋糖酐絮凝能力的方法
WO2024082390A1 (fr) * 2022-10-18 2024-04-25 天津德祥生物技术股份有限公司 Utilisation d'un conjugué trisaccharide d'antigène de groupe sanguin dans la détection d'anticorps de groupe sanguin
EP4637947A1 (fr) * 2022-12-19 2025-10-29 Eli Lilly and Company Procédés de nettoyage de matrices de chromatographie
FR3152409A1 (fr) 2023-09-04 2025-03-07 Maco Pharma Procédé pour l’élimination sélective des leucocytes et des érythrocytes d’un produit concentré en plaquettes
FR3152408A1 (fr) 2023-09-04 2025-03-07 Maco Pharma Procédé pour l’obtention d’un produit concentré en plaquettes réduit en anticorps anti-A et/ou anti-B
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CN106995496A (zh) 2017-08-01
EP3141558B1 (fr) 2019-05-22
CA2938544C (fr) 2020-03-24
EP3141558B2 (fr) 2022-02-16
US12441809B2 (en) 2025-10-14
AU2016219569B2 (en) 2018-05-17
KR101952228B1 (ko) 2019-02-26
AU2016219569A1 (en) 2017-03-23
US20210047430A1 (en) 2021-02-18
JP2017053846A (ja) 2017-03-16
ES2737731T3 (es) 2020-01-15
JP6494572B2 (ja) 2019-04-03
SG10201606493XA (en) 2017-04-27
CA2938544A1 (fr) 2017-03-08
KR20170030033A (ko) 2017-03-16
ES2737731T5 (es) 2022-05-09
EP3141558A1 (fr) 2017-03-15

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