JP6444871B2 - 抗プロラクチン受容体抗体製剤 - Google Patents
抗プロラクチン受容体抗体製剤 Download PDFInfo
- Publication number
- JP6444871B2 JP6444871B2 JP2015529978A JP2015529978A JP6444871B2 JP 6444871 B2 JP6444871 B2 JP 6444871B2 JP 2015529978 A JP2015529978 A JP 2015529978A JP 2015529978 A JP2015529978 A JP 2015529978A JP 6444871 B2 JP6444871 B2 JP 6444871B2
- Authority
- JP
- Japan
- Prior art keywords
- prlr antibody
- prlr
- antibody preparation
- sucrose
- histidine
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2869—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against hormone receptors
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- A—HUMAN NECESSITIES
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- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
-
- A—HUMAN NECESSITIES
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- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39591—Stabilisation, fragmentation
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- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A—HUMAN NECESSITIES
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- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
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- 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
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/51—Complete heavy chain or Fd fragment, i.e. VH + CH1
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- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/515—Complete light chain, i.e. VL + CL
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
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- C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
Description
抗体溶液の濁度に対するNaCl濃度およびpHの影響
この実施例は、PCT特許公開番号国際公開第2011/069799号パンフレット、国際公開第2011/069798号パンフレット、国際公開第2011/069797号パンフレット、国際公開第2011/069796号パンフレット、国際公開第2011/069795号パンフレットおよび国際公開第2011/069794号パンフレットの1つまたは複数に記載されている軽鎖配列および重鎖配列を含む抗PRLRヒトモノクローナル抗体を含む溶液の凝集に対する塩(NaCl)濃度およびpHの影響を開示している。溶液の濁度を目視によって評価して、aPRLR mAb溶液に対する塩濃度およびpHの影響を迅速に評価する。pH5.5〜6.5で塩の存在しない製剤では5℃および25℃で2か月後に沈殿は観察されない。
抗PRLR抗体製剤
NaClを用いないで実質的に等浸透圧性の高濃度抗PRLR Ab製剤を調製する。これらの製剤は、抗PRLR Abを安定化するのを助けるために高いスクロース濃度を使用する。
Claims (30)
- a.10mM〜70mMのヒスチジンと、
b.50ppm〜300ppmのポリソルベート20およびポリソルベート80から選択される非イオン界面活性剤と、
c.34mM〜292mMのスクロースである糖と、
d.0mM〜50mMのアルギニンと、
e.0mM〜50mMのリジンと、
f.0mM〜270mMのグリシンまたはアラニンと、
g.0mM〜10mMのメチオニンと、
h.1mg/ml〜150mg/mlの抗PRLR抗体と
を含む、抗PRLR抗体製剤であって、
pH5.0〜pH6.5に及ぶpHを有する抗PRLR抗体製剤であって、塩化ナトリウム(NaCl)、硫酸ナトリウム(Na2SO4)、チオシアン酸ナトリウム(NaSCN)、塩化マグネシウム(MgCl)、硫酸マグネシウム(MgSO4)、チオシアン酸アンモニウム(NH4SCN)、硫酸アンモニウム((NH4)2SO4)、塩化アンモニウム(NH4Cl)、塩化カルシウム(CaCl2)、硫酸カルシウム(CaSO4)および塩化亜鉛(ZnCl2)からなる群から選択される無機塩をいずれも実質的に含まない、抗PRLR抗体製剤。 - 22℃〜23℃で1〜8mPa・Sに及ぶ粘度を有する、請求項1に記載の抗PRLR抗体製剤。
- 240〜380mmol/kgに及ぶ重量オスモル濃度を有する、請求項1に記載の抗PRLR抗体製剤。
- 10mM〜50mMの間のアルギニンを含む、請求項1に記載の抗PRLR抗体製剤。
- a.30mMのヒスチジンと、
b.100ppmのポリソルベート80と、
c.292mMのスクロースと、
d.20mg/mlの抗PRLR抗体と
を含む、請求項1に記載の抗PRLR抗体製剤であって、
pH5.0〜pH6.5に及ぶpHを有する抗PRLR抗体製剤。 - a.10mMのヒスチジンと、
b.80ppmのポリソルベート80と、
c.234mMのスクロースと、
d.60mg/mlの抗PRLR抗体と
を含む、請求項1に記載の抗PRLR抗体製剤であって、
pH5.0〜pH6.5に及ぶpHを有する抗PRLR抗体製剤。 - a.10mMのヒスチジンと、
b.75ppmのポリソルベート80と、
c.234mMのスクロースと、
d.60mg/mlの抗PRLR抗体と
を含む、請求項1に記載の抗PRLR抗体製剤であって、
pH5.0〜pH6.5に及ぶpHを有する抗PRLR抗体製剤。 - a.10mMのヒスチジンと、
b.75ppmのポリソルベート80と、
c.88mMのスクロースと、
d.270mMのグリシンと、
e.60mg/mlの抗PRLR抗体と
を含む、請求項1に記載の抗PRLR抗体製剤であって、
pH5.0〜pH6.5に及ぶpHを有する抗PRLR抗体製剤。 - a.10mMのヒスチジンと、
b.75ppmのポリソルベート20と、
c.88mMのスクロースと、
d.133mMのグリシンと、
e.60mg/mlの抗PRLR抗体と
を含む、請求項1に記載の抗PRLR抗体製剤であって、
pH5.0〜pH6.5に及ぶpHを有する抗PRLR抗体製剤。 - a.10mMのヒスチジンと、
b.200ppmのポリソルベート20と、
c.88mMのスクロースと、
d.133mMのグリシンと、
e.60mg/mlの抗PRLR抗体と
を含む、請求項1に記載の抗PRLR抗体製剤であって、
pH5.0〜pH6.5に及ぶpHを有する抗PRLR抗体製剤。 - a.70mMのヒスチジンと、
b.80ppmのポリソルベート80と、
c.200mMのスクロースと、
d.60mg/mlの抗PRLR抗体と
を含む、請求項1に記載の抗PRLR抗体製剤であって、
pH5.0〜pH6.5に及ぶpHを有する抗PRLR抗体製剤。 - a.10mMのヒスチジンと、
b.75ppmのポリソルベート80と、
c.292mMのスクロースと、
d.10mMのアルギニンと、
e.60mg/mlの抗PRLR抗体と
を含む、請求項1に記載の抗PRLR抗体製剤であって、
pH5.0〜pH6.5に及ぶpHを有する抗PRLR抗体製剤。 - a.70mMのヒスチジンと、
b.75ppmのポリソルベート80と、
c.176mMのスクロースと、
d.30mMのリジンと、
e.60mg/mlの抗PRLR抗体と
を含む、請求項1に記載の抗PRLR抗体製剤であって、
pH5.0〜pH6.5に及ぶpHを有する抗PRLR抗体製剤。 - a.10mMのヒスチジンと、
b.75ppmのポリソルベート80と、
c.234mMのスクロースと、
d.30mMのアルギニンと、
e.10mMのメチオニンと、
f.60mg/mlの抗PRLR抗体と
を含む、請求項1に記載の抗PRLR抗体製剤であって、
pH5.0〜pH6.5に及ぶpHを有する抗PRLR抗体製剤。 - a.10mMのヒスチジンと、
b.75ppmのポリソルベート80と、
c.234mMのスクロースと、
d.30mMのアルギニンと、
e.10mMのメチオニンと、
f.2mg/mlの抗PRLR抗体と
を含む、請求項1に記載の抗PRLR抗体製剤であって、
pH5.0〜pH6.5に及ぶpHを有する抗PRLR抗体製剤。 - a.10mMのヒスチジンと、
b.75ppmのポリソルベート80と、
c.234mMのスクロースと、
d.20mMのアルギニンと、
e.10mMのメチオニンと、
f.150mg/mlの抗PRLR抗体と
を含む、請求項1に記載の抗PRLR抗体製剤であって、
pH5.0〜pH6.5に及ぶpHを有する抗PRLR抗体製剤。 - a.10mMのヒスチジンと、
b.75ppmのポリソルベート80と、
c.205mMのスクロースと、
d.20mMのアルギニンと、
e.10mMのメチオニンと、
f.1mg/mlの抗PRLR抗体と
を含む、請求項1に記載の抗PRLR抗体製剤であって、
pH5.0〜pH6.5に及ぶpHを有する抗PRLR抗体製剤。 - a.10mMのヒスチジンと、
b.80ppmのポリソルベート80と、
c.205mMのスクロースと、
d.20mMのアルギニンと、
e.10mMのメチオニンと、
f.60mg/mlの抗PRLR抗体と
を含む、請求項1に記載の抗PRLR抗体製剤であって、
pH5.0〜pH6.5に及ぶpHを有する抗PRLR抗体製剤。 - a.10mMのヒスチジンと、
b.234mMのスクロースと、
c.80ppmのポリソルベート80と、
d.30mMのアルギニンと、
e.5mMのメチオニンと、
f.7.5mg/mlの抗PRLR抗体と
を含む、請求項1に記載の抗PRLR抗体製剤であって、
pH5.0〜pH6.5に及ぶpHを有する抗PRLR抗体製剤。 - a.10mMのヒスチジンと、
b.234mMのスクロースと、
c.80ppmのポリソルベート80と、
d.30mMのアルギニンと、
e.5mMのメチオニンと、
f.60mg/mlの抗PRLR抗体と
を含む、請求項1に記載の抗PRLR抗体製剤であって、
pH5.0〜pH6.5に及ぶpHを有する抗PRLR抗体製剤。 - a.10mMのヒスチジンと、
b.234mMのスクロースと、
c.75ppmのポリソルベート80と、
d.30mMのアルギニンと、
e.10mMのメチオニンと、
f.60mg/mlの抗PRLR抗体と
を含む、請求項1に記載の抗PRLR抗体製剤であって、
pH5.0〜pH6.5に及ぶpHを有する抗PRLR抗体製剤。 - a.10mMのヒスチジンと、
b.263mMのスクロースと、
c.80ppmのポリソルベート80と、
d.60mg/mlの抗PRLR抗体と
を含む、請求項1に記載の抗PRLR抗体製剤であって、
pH5.0〜pH6.5に及ぶpHを有する抗PRLR抗体製剤。 - 前記抗PRLR抗体がヒトIgG2モノクローナル抗体である、請求項1に記載の抗PRLR抗体製剤。
- 前記ヒトIgG2モノクローナル抗体が配列番号1の軽鎖配列および配列番号7の重鎖配列を含む、請求項23に記載の抗PRLR抗体製剤。
- pH5.0〜pH6.5の間のpHで10mM〜70mMの間のヒスチジンと、50ppm〜200ppmの間のポリソルベート80またはポリソルベート20と、34mM〜292mMの間のスクロースと、0mM〜50mMの間のアルギニンと、0mM〜50mMの間のリジンと、0mM〜270mMの間のグリシンまたはアラニンと、0mM〜10mMの間のメチオニンと、1mg/ml〜150mg/mlの間のタンパク質または抗体とを含み、塩化ナトリウム(NaCl)、硫酸ナトリウム(Na2SO4)、チオシアン酸ナトリウム(NaSCN)、塩化マグネシウム(MgCl)、硫酸マグネシウム(MgSO4)、チオシアン酸アンモニウム(NH4SCN)、硫酸アンモニウム((NH4)2SO4)、塩化アンモニウム(NH4Cl)、塩化カルシウム(CaCl2)、硫酸カルシウム(CaSO4)および塩化亜鉛(ZnCl2)からなる群から選択される無機塩をいずれも実質的に含まない、患者の子宮内膜症の非ホルモン治療のための抗PRLR抗体製剤。
- 静脈内、皮下または筋肉内投与される、請求項26に記載の抗PRLR抗体製剤。
- 前記抗PRLR抗体がヒトIgG2モノクローナル抗体である、請求項27に記載の抗PRLR抗体製剤。
- 前記ヒトIgG2モノクローナル抗体が配列番号1の軽鎖配列および配列番号7の重鎖配列を含む、請求項28に記載の抗PRLR抗体製剤。
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