In the biopharmaceutical industry, therapeutic monoclonal antibodies are primarily
produced in mammalian cell culture systems. During the scale-up of a monoclonal antibody …

… Further, the MBP–CpxPA24D protein migrated at a slightly higher molecular weight than the
… and reduced levels of the higher molecular weight precursor protein after incubation relative …

The long serum half-lives of mAbs are conferred by pH-dependent binding of IgG-Fc to the
neonatal Fc receptor (FcRn). The Fc region of human IgG1 has three conserved methionine …

We recently observed a significant disulfide reduction problem during the scale‐up of a
manufacturing process for a therapeutic antibody using a CHO expression system. Under certain …

Historically, therapeutic protein production in Chinese hamster ovary (CHO) cells has been
accomplished by random integration (RI) of expression plasmids into the host cell genome. …

Amino acid sequence variants are defined as unintended amino acid sequence changes that
contribute to product variation with potential impact to product safety, immunogenicity, and …

… Extracted ion chromatogram of the Ser to Asn variant peptide at a MW of 2,477 Da. Protein
A-purified MAb-B product samples of the reference (S63AGC) cell line and from one cell line …

Cell line development (CLD) by random integration (RI) can be labor intensive, inconsistent,
and unpredictable due to uncontrolled gene integration after transfection. Unlike RI, …

During large-scale manufacturing of an IgG1 monoclonal antibody in Chinese hamster
ovary (CHO) cells, reduction of the antibody's disulfide bonds was observed. We present …

The goal of quality by design (QbD) in cell culture manufacturing is to develop manufacturing
processes which deliver products with consistent critical quality attributes (CQAs). QbD …