Title:
METHOD FOR DETERMINING THE IN VIVO COMPARABILITY OF BIOLOGIC DRUG AND A REFERENCE DRUG
Document Type and Number:
WIPO Patent Application WO/2017/053792
Kind Code:
A8
Abstract:
The invention provides a mass-spectroscopic approach for assessing and determining the in vivo comparability of a candidate biologic molecule to a reference biologic molecule. The results can be presented in the form of an in vivo comparability profile, which can serve as a development tool, e.g., as a guide or target for the development of biologies, biosimilars,or gene therapy-based drugs. The invention further provides an approach using an in vivo comparability profile for measuring the similarity of two biologies, for example, a biosimilar and a reference approved biologic or manufacturing lots of the same biologic to confirm acceptable release criteria for a particular manufacturing lot.
Inventors:
LI LILY Y T (US)
POSS KIRTLAND G (US)
WU SHIAW-LIN (US)
GARNICK ROBERT (US)
POSS KIRTLAND G (US)
WU SHIAW-LIN (US)
GARNICK ROBERT (US)
Application Number:
PCT/US2016/053434
Publication Date:
May 04, 2017
Filing Date:
September 23, 2016
Export Citation:
Assignee:
BIOANALYTIX INC (US)
International Classes:
G01N33/68
Attorney, Agent or Firm:
GREENHALGH, Duncan, A. et al. (US)
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