EA202092510A1 - Квалификация хроматографической колонки в способах производства для получения композиций антител к tnf - Google Patents

Квалификация хроматографической колонки в способах производства для получения композиций антител к tnf

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EA202092510A1
EA202092510A1 EA202092510A EA202092510A EA202092510A1 EA 202092510 A1 EA202092510 A1 EA 202092510A1 EA 202092510 A EA202092510 A EA 202092510A EA 202092510 A EA202092510 A EA 202092510A EA 202092510 A1 EA202092510 A1 EA 202092510A1
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column
parameters
hetp
mobile phase
tnf
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EA202092510A
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EA039041B1 (ru
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Пол Рэндолф
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Янссен Байотек, Инк.
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    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
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    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
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    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/36—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction
    • B01D15/361—Ion-exchange
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
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    • B01D15/361—Ion-exchange
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    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
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    • 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 - B01D15/36
    • B01D15/3804—Affinity chromatography
    • B01D15/3809—Affinity chromatography of the antigen-antibody type, e.g. protein A, G, L chromatography
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    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
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    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
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    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
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Abstract

Изобретение относится к способу эксплуатации колонки в промышленных способах изготовления антител к TNF, например антител к TNF- SIMPONI (голимумаб), и конкретных фармацевтических композиций антител. Этот способ включает регистрацию выходного сигнала колонки и параметров суммарного потока через два или более интервалов по меньшей мере одного переходного фронта подвижной фазы во время эксплуатации хроматографической колонки, содержащей насадку колонки. Модельную кумулятивную кривую гамма-распределения определяют на основе регистрируемого выходного сигнала колонки и параметров суммарного потока для по меньшей мере одного переходного фронта подвижной фазы. Значение высоты, эквивалентной теоретической тарелке (ВЭТТ) рассчитывают для по меньшей мере одного переходного фронта подвижной фазы с использованием параметров кумулятивной кривой гамма-распределения, а качество насадки хроматографической колонки оценивают на основе рассчитанного значения ВЭТТ. Если во время регулярного мониторинга колонок наблюдают неблагоприятный тренд в ВЭТТ или превышение контрольных пределов, то для обеспечения качества продукта элюата следует оценить данные производительности процесса с использованием колонки и/или данные очистки примесей для обеспечения качества продукта из выявленной партии. Если качество продукта или производительность не соответствуют установленным критериям, перед запуском в дальнейшую эксплуатацию необходимо предпринять соответствующее корректирующее действие, такое как кондиционирование, повторное наполнение или замена колонки, и провести квалификацию.
EA202092510A 2018-04-20 2019-04-19 Квалификация хроматографической колонки в способах производства для получения композиций антител к tnf EA039041B1 (ru)

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Application Number Priority Date Filing Date Title
US201862660340P 2018-04-20 2018-04-20
PCT/US2019/028314 WO2019204721A1 (en) 2018-04-20 2019-04-19 Chromatography column qualification in manufacturing methods for produring anti-tnf antibody compositions

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EA202092510A1 true EA202092510A1 (ru) 2020-12-22
EA039041B1 EA039041B1 (ru) 2021-11-25

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EA202192301A EA202192301A1 (ru) 2018-04-20 2019-04-19 Квалификация хроматографической колонки в способах производства для получения композиций антител к tnf
EA202092510A EA039041B1 (ru) 2018-04-20 2019-04-19 Квалификация хроматографической колонки в способах производства для получения композиций антител к tnf
EA202092511A EA039018B1 (ru) 2018-04-20 2019-04-19 Квалификационное исследование хроматографической колонки в способах производства для получения композиций на основе антител к il-12/il-23
EA202192300A EA202192300A1 (ru) 2018-04-20 2019-04-19 Квалификационное исследование хроматографической колонки в способах производства для получения композиций на основе антител к il-12/il-23

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EA202192300A EA202192300A1 (ru) 2018-04-20 2019-04-19 Квалификационное исследование хроматографической колонки в способах производства для получения композиций на основе антител к il-12/il-23

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JP (3) JP2021522477A (ru)
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AU (2) AU2019256647A1 (ru)
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