Patent · US Active

Process and methods for efficient manufacturing of highly pure asymmetric antibodies in mammalian cells

US9499634B2 · kind B2 · utility

36Cited by
21References
30Claims
0Family size

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Key dates

Filing dateJun 25, 2013
Grant dateNov 22, 2016
Priority date
Expiry dateFeb 25, 2034

Classification

  • Technology area (CPC C)Chemistry; Metallurgy
  • CPC primaryC07K2317/64
  • WIPO fieldBiotechnology
  • WIPO sectorChemistry

Abstract

The present invention provides a process and methods for producing asymmetric antibodies in a mammalian expression system. The asymmetric antibodies are transiently or stably expressed and in cells that stably express the asymmetric antibody, following a rapid 2-step process of stable pool to clone, a highly pure asymmetric antibody expressing clone can be identified at a success frequency that permits for screening of tens of clones rather than thousands. The asymmetric antibodies are produced at a high titre and with a high level of purity with no contaminating homodimer antibodies following protein A purification with a step yield of near 100%. Typical downstream purification processes employ standard hydrophobic interaction chromatography (HIC) and/or cation exchange (CEX) resins and the antibody is stable within a wide dynamic range of buffer pH (4-8) and within the requirements for manufacturing antibodies for pre-clinical and clinical applications.

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