CA2954767A1

CA2954767A1 - Crystalline antibody formulations

Crystalline antibody formulations Download PDF

Info

Publication number: CA2954767A1
Authority: CA; Canada
Prior art keywords: antibody; seq; phosphate; crystals; sodium
Prior art date: 2014-07-14
Legal status : Abandoned

Application number

CA2954767A

Other languages

English (en)

French (fr)

Inventor

Nazer Khalaf

Saraswathi MANDAPATI

Reena J. Patel

Current Assignee

Amgen Inc

Original Assignee

Amgen Inc

Priority date

2014-07-14

Filing date

2015-07-13

Publication date

2016-01-21

2015-07-13 Application filed by Amgen Inc filed Critical Amgen Inc

2016-01-21 Publication of CA2954767A1 publication Critical patent/CA2954767A1/en

Status Abandoned legal-status Critical Current

Links

239000000203 mixture Substances 0.000 title claims abstract description 184
238000009472 formulation Methods 0.000 title claims abstract description 148
239000013078 crystal Substances 0.000 claims abstract description 263
238000000034 method Methods 0.000 claims abstract description 63
238000002425 crystallisation Methods 0.000 claims description 69
230000008025 crystallization Effects 0.000 claims description 68
125000003275 alpha amino acid group Chemical group 0.000 claims description 48
235000002639 sodium chloride Nutrition 0.000 claims description 46
LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 claims description 41
239000007983 Tris buffer Substances 0.000 claims description 40
239000000243 solution Substances 0.000 claims description 35
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FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 25
MNNHAPBLZZVQHP-UHFFFAOYSA-N diammonium hydrogen phosphate Chemical compound [NH4+].[NH4+].OP([O-])([O-])=O MNNHAPBLZZVQHP-UHFFFAOYSA-N 0.000 claims description 22
239000003153 chemical reaction reagent Substances 0.000 claims description 20
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239000006259 organic additive Substances 0.000 claims description 13
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LWIHDJKSTIGBAC-UHFFFAOYSA-K tripotassium phosphate Chemical compound [K+].[K+].[K+].[O-]P([O-])([O-])=O LWIHDJKSTIGBAC-UHFFFAOYSA-K 0.000 claims description 12
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IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims description 8
239000011548 crystallization buffer Substances 0.000 claims description 8
ZPWVASYFFYYZEW-UHFFFAOYSA-L dipotassium hydrogen phosphate Chemical compound [K+].[K+].OP([O-])([O-])=O ZPWVASYFFYYZEW-UHFFFAOYSA-L 0.000 claims description 8
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