Polyclonal antibodies against recombinant human nerve growth factor (rhNGF) potently
inhibited PC12 neurite outgrowth, blocked high‐affinity 125 I‐rhNGF binding but not its receptor, …

An enzyme-linked immunosorbent assay (ELISA) has been developed for the quantitation of
part-per-million levels of the most probable E. coli polypeptide (ECP) contaminants of E. coli …

A rapid, sensitive, and high-capacity assay has been developed to quantify ligand-induced
receptor tyrosine kinase activation in terms of receptor phosphorylation. The assay, termed a “…

Such instances of rapid clinical success and early stage technology have led to the use of
ineffective, non-optimal equipment on the upstream side; for example, thousands of roller …

This report describes a specific radioimmunoprecipitation (RIP) assay for the detection of
antibodies to recombinant DNA (rDNA) derived human gamma-interferon (rHuIFN-γ). The …

Three immunization procedures were compared for the production of antibodies to the minor
components of a complexE. coli protein (ECP) mixture: a conventional protocol and two …

A key challenge in biotechnology is the production of proteins by large-scale cell culture in a
cost-effective manner. The development of efficient and reproducible separation processes …

The presence of impurities in protein pharmaceuticals may effect the biochemical quality of
the product or result in detrimental effects on the drug recipient. To optimize separation …

According to the FDA guidelines (1), pilot plant facilities may be used to generate material to
support process validation studies. The guidelines also state that process modifications are …

1.1 Background The 2012 Food Drug Administration Safety and Innovation Act (FDASIA)
gave FDA new tools to encourage high quality manufacturing of pharmaceuticals and …