Quantitative determination of humanized monoclonal antibody rhuMAb2H7 in cynomolgus monkey serum using a Generic Immunoglobulin Pharmacokinetic (GRIP) assay.

Preclinical pharmacokinetic (PK) assays are important to help evaluate the safety and efficacy of a potential biotherapeutic before clinical studies. The assay typically requires a biotherapeutic-specific reagent to minimize matrix effects especially when the host species are non-human primates such as cynomolgus monkeys and the biotherapeutic is a humanized monoclonal antibody (MAb). Recombinant humanized mAb 2H7 (rhuMAb2H7) binds to the extracellular domain of CD20 that is expressed on B cells and results in B cell depletion.

Depletion of B cells by a humanized anti-CD20 antibody PRO70769 in Macaca fascicularis.

PRO70769 is a humanized IgG1 monoclonal antibody against the CD20 molecule that is present on normal and malignant B cells. PRO70769 is being evaluated for treatment of B-cell-mediated diseases and is in a phase 1 trial for rheumatoid arthritis. As part of the preclinical toxicology evaluation, B-cell depletion profiles and safety of PRO70769 were assessed in cynomolgus monkeys.

An evaluation of the accuracy of four ELISA methods for measuring natural and recombinant human interferon-g.

We describe an evaluation of four ELISA methods, including three commercial kits, for measuring recombinant and natural human interferon-g (hIFN-g). Using a panel of samples, including well-characterized reference standards, we compared relative quantification between assays, within assays and, where possible, the absolute accuracy of quantification as compared to other analytical methods. The four assays generated markedly different results; up to an almost 60-fold difference between the highest and lowest values for one sample.

Simulation of paretic gait in normal subjects by loading the ankles.

Normal subjects were loaded with increasing weights (2-6 kg) applied around the ankles. During these conditions stride length increased in relation to velocity. The percentage duration of single support in relation to stride duration increased.