Methods of determining interferon having direct inhibitory effects on tumors and uses thereof
AssigneeSuperlab Far East Limited
InventorGuangwen Wei
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Abstract
The invention provides novel methods of determining or comparing potency of a test interferon relative to rSIFN-co (an interferon having therapeutic effects on solid tumors); methods of establishing substantial equivalence between a test interferon and rSIFN-co; as well as methods for determining potency of a test interferon, kits for determination of such methods, and an interferon or an interferon substitute having said activities.
Claims11
A method of determining or comparing potency of a test interferon relative to Recombinant Super-Compound Interferon (rSIFN-co), or establishing substantial equivalence between a test interferon and rSIFN-co, comprising the steps of:
- (1) providing a first sample, a second sample and a third sample of cancer cells of the same type;
- (2) treating the first sample with the test interferon, treating the second sample with rSIFN-co, and using the third sample as a control sample;
- and
- (3) measuring binding affinity of said test interferon and rSIFN-co to Interferon Alpha And Beta Receptor Subunit 1 (IFNAR1) and Interferon Alpha And Beta Receptor Subunit 2 (IFNAR2) in the first, second and third samples;
- wherein similar binding affinity to IFNAR1 between the first and second samples, and similar binding affinity to IFNAR2 between the first and second sample indicates substantial equivalence between the test interferon and the rSIFN-co.
Dependencies are inferred from the claim text.