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RU2510400C2 - Способ модификации изоэлектрической точки антитела с помощью аминокислотных замен в cdr - Google Patents

Способ модификации изоэлектрической точки антитела с помощью аминокислотных замен в cdr Download PDF

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RU2510400C2
RU2510400C2 RU2010116208/10A RU2010116208A RU2510400C2 RU 2510400 C2 RU2510400 C2 RU 2510400C2 RU 2010116208/10 A RU2010116208/10 A RU 2010116208/10A RU 2010116208 A RU2010116208 A RU 2010116208A RU 2510400 C2 RU2510400 C2 RU 2510400C2
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antibody
amino acid
acid residues
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amino
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Томоюки ИГАВА
Хироюки ЦУНОДА
Тацухико ТАТИБАНА
Таити КУРАМОТИ
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Abstract

Изобретение относится к области биохимии, в частности к способу получения антитела, у которого изменены фармакокинетические свойства при сохранении антиген-связывающей активности вариабельной области, который предусматривает стадии: (а) получение антител, в которых модифицирован заряд аминокислотных остатков, выбранных из аминокислотных остатков в положениях 31, 61, 62, 64 и 65 вариабельной области тяжелой цепи и в положениях 24, 27, 53, 54 и 55 вариабельной области легкой цепи в соответствии с нумерацией по системе Кабата, где модификация заряда аминокислотных остатков приводит к изменению 1,0 или более в теоретической изоэлектрической точке вариабельной области антитела, и (b) отбор антитела с сохраненной антиген-связывающей активностью от антител, полученных на стадии (а). Изобретение позволяет эффективно изменять фармакокинетические свойства антитела, сохраняя его антиген-связывающую активность. 7 з.п. ф-лы, 62 ил., 34 табл.

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Claims (8)

1. Способ получения антитела, у которого изменены фармакокинетические свойства в плазме при сохранении антиген-связывающей активности вариабельной области, который предусматривает стадии:
(а) получение антител, в которых модифицирован заряд аминокислотных остатков, выбранных из аминокислотных остатков в положениях 31, 61, 62, 64 и 65 вариабельной области тяжелой цепи и в положениях 24, 27, 53, 54 и 55 вариабельной области легкой цепи в соответствии с нумерацией по системе Кабата, где модификация заряда аминокислотных остатков приводит к изменению 1,0 или более в теоретической изоэлектрической точке вариабельной области антитела, и
(b) отбор антитела с сохраненной антиген-связывающей активностью от антител, полученных на стадии (а).
2. Способ по п.1, где антитело дополнительно содержит FcRn-связывающий домен.
3. Способ по п.1, где антитело представляет собой антитело IgG.
4. Способ по п.1, где антитело представляет собой химерное антитело, гуманизированное антитело или антитело человека.
5. Способ по п.1, где антитело представляет собой полиспецифическое антитело, которое связывается по меньшей мере с двумя типами антигенов.
6. Способ по п.1, где заряд аминокислотного остатка модифицирован с помощью замены аминокислоты.
7. Способ по п.1, где модифицированная аминокислота выбрана из аминокислотных остатков любой группы (а) или (b) ниже:
(а) глутаминовая кислота (E) и аспарагиновая кислота (D); и
(b) лизин (K), аргинин (R) и гистидин (H).
8. Способ по п.1, где изменение фармакокинетических параметров относится к увеличению или уменьшению любого параметра из клиренса (CL) плазмы, площади под кривой концентрации (AUC), среднего времени удержания в плазме и времени полужизни в плазме (t1/2).
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