Conjugation of polyethylene glycols (PEGs) to proteins or drug delivery nanosystems is a
widely accepted method to increase the therapeutic index of complex nano …

Bioanalytical methods have experienced unprecedented growth in recent years, driven in
large part by the need for faster, more sensitive, more portable (“point of care”) systems to …

Here, we review the current state of the art in analytical and structural methods used to
characterize therapeutic monoclonal antibodies (mAbs) and derivatives. First, a general …

Extensive medical research showed that patients, with high protein concentration in urine,
have various kinds of kidney diseases, referred to as proteinuria. Urinary protein biomarkers …

Workshop/Conference Report Bioanalytical Method Validation—A Revisit with a Decade of
Progress Page 1 Workshop/Conference Report Bioanalytical Method Validation—A Revisit with …

Despite major advances in modern drug discovery and development, the number of new
drug approvals has not kept pace with the increased cost of their development. Increasingly …

Most biological drug products elicit some level of anti-drug antibody (ADA) response. This
antibody response can, in some cases, lead to potentially serious side effects and/or loss of …

Most biopharmaceutical therapeutics elicit some level of antibody response against the
product. This antibody response can, in some cases, lead to potentially serious side effects …

Purpose. With this publication a subcommittee of the AAPS Ligand Binding Assay
Bioanalytical Focus Group (LBABFG) makes recommendations for the development …

Calibration curve is a regression model used to predict the unknown concentrations of
analytes of interest based on the response of the instrument to the known standards. Some …