Anergy is a mechanism of T lymphocyte tolerance induced by antigen receptor stimulation
in the absence of co-stimulation. Anergic T cells were shown to have a defect in antigen-…

Viral safety is a predominant concern for monoclonal antibodies (mAbs) and other recombinant
proteins (RPs) with pharmaceutical applications. Certain commercial purification modules…

The N-linked glycan profiles on recombinant monoclonal antibody therapeutics significantly
affect antibody biological functions and are largely determined by host cell genotypes and …

There is a trend across the pharmaceutical sector toward process intensification and
continuous manufacturing to produce small-molecule drugs or biotechnology products. For …

Demonstration of viral clearance is a critical step in assuring the safety of biotechnology
products. We generated a viral clearance database that contains product information, unit …

Using the polyfructose, bacterial levan, as a model polysaccharide, we analyzed how V regions
affect binding in anti-polysaccharide mAbs. Previously, panels of mAb were constructed …

The breakthrough of a model virus, bacteriophage ΦX‐174, through normal‐flow virus filters
was studied using both commercial process fluids and model feedstreams. The results …

Mycoplasmas, particularly species of the genera Mycoplasma and Acholeplasma, are
known to be occasional microbial contaminants of cell cultures that produce biologics. This …

Cell culture optimization is a labor-intensive process requiring a large number of experiments
to be conducted under varying conditions. Here we describe a high-throughput bioreactor …

The potential of viral contamination is a regulatory concern for continuous cell line‐derived
pharmaceutical proteins. Complementary and redundant safety steps, including an …