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NCL Method ITA-18

By Timothy Potter, Edward Cedrone, Barry Neun, Marina Dobrovolskaia

Human Leukocyte Proliferation Assay (HuLa)

Listed in Datasets | publication by group NCL Protocols

Version 2.0 - published on 09 Jul 2020 doi:10.17917/3429-7641 - cite this Last public release: 2.0b

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Description

Immunosuppression is a common reason for drug withdrawal from the market. The traditional immune function test used to estimate materials’ immunosuppression is T cell dependent antibody response (TDAR). This method involves a 28 day, in vivo, study evaluating animal antibody titers to a known antigen (KLH) with and without challenge. Due to the limited quantities of novel drug candidates, an in vitro method called Human Leukocyte activation (HuLa) has been developed as a substitute to the traditional TDAR assay in early preclinical development. The method presented herein is based on the HuLa assay originally developed by Mark Collinge et al at Pfizer (1). The protocol presented in this document has been adapted for use with engineered nanomaterials.

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