Host cell proteins (HCPs) are process‐related impurities that may copurify with
biopharmaceutical drug products. Within this class of impurities there are some that are …

Highlights•The CHO genome suffers from chromosomal rearrangements and other stability-
related issues.•The CHO cell instability phenotype is characterized by titer instability and …

The use of biological systems to synthesize complex therapeutic products has been a
remarkable success. However, during product development, great attention must be devoted …

In the 40‐year history of biopharmaceuticals, there have been a few cases where the final
products contained residual host cell protein (HCP) impurities at levels high enough to be of …

Two-dimensional polyacrylamide gel electrophoresis (2D-PAGE) continues to be one of the
most versatile and widely used techniques to study the proteome of a biological system. In …

Therapeutic proteins including monoclonal antibodies (mAbs) are usually produced in
engineered host cell lines that also produce thousands of endogenous proteins at varying …

Highlights•Cell viability and time of harvest impacts greatly on the subsequent HCP
profile.•Primary and secondary clarification decisions impact on the HCP profile.•HCPs in …

ABSTRACT A potential risk factor for immunogenicity of a biotherapeutic is the low levels of
host cell protein (HCP) impurities that remain in the product following the purification …

The repertoire of complex proteins produced by the host cell during monoclonal antibody
(mAb) production has generated a bottleneck in downstream bioprocessing. Low ppm levels …

Host cell proteins (HCPs) are bioprocess-related impurities arising from cell-death or
secretion from nonhuman cells used for recombinant protein production. Clearance of HCPs …