Purpose: Therapeutic proteins are sensitive to photo-degradation by UV A and visible light.
As none of the essential amino acids exhibits significant absorption in the UV A and visible …

The success of biotherapeutic development heavily relies on establishing robust production
platforms. During the manufacturing process, the protein is exposed to multiple stress …

Photostability studies are standard stress testing conducted during drug product
development of various pharmaceutical compounds, including small molecules and …

During biopharmaceutical process development, it is important to improve titer to reduce
drug manufacturing costs and to deliver comparable quality attributes of therapeutic …

Process changes are inevitable in the life cycle of recombinant monoclonal antibody
therapeutics. Products made using pre-and post-change processes are required to be …

Rapid technological advances have significantly improved the capability, versatility, and
robustness of mass spectrometers which has led to them playing a central role in the …

Recombinant monoclonal antibodies are commonly expressed in mammalian cell culture
and purified by several steps of filtration and chromatography. The resulting high purity bulk …

IgG4s are dynamic molecules that undergo a process called Fab-arm exchange. Disulfide
bonds between heavy chains are transiently reduced, resulting in half antibodies that reform …

Monoclonal antibody interchain disulfide bond reduction was observed in a Chinese
Hamster Ovary manufacturing process that used single‐use technologies. A similar …

Therapeutic monoclonal antibody (mAb) drug products are increasingly used to treat both
chronic and acute diseases. These mAb drug products are often developed for …