The role in human health of therapeutic proteins in general, and monoclonal antibodies
(mAbs) in particular, has been significant and is continuously evolving. A considerable …

Reactive impurities in excipients can cause drug product degradation or protein modification
even at trace levels, and thus impact drug stability and quality. It is critical to understand the …

Purpose Enzymatic polysorbate (PS) degradation and resulting free fatty acid (FFA) particles
are detrimental to biopharmaceutical drug product (DP) stability. Different types and grades …

Photostability testing of therapeutic proteins is a critical requirement in the development of
biologics. Upon exposure to light, pharmaceutical proteins may undergo a change in …

Abstract Super Refined™ and Tween™ 20 HP polysorbate 20 (PS20) are two commercially
available compendial grades of PS20 frequently used in biopharmaceutical formulations as …

Injectable protein-based medicinal products (drug products, or DPs) must be produced by
using sterile manufacturing processes to ensure product safety. In DP manufacturing the …

Purpose Biotherapeutics can be susceptible to oxidation during manufacturing and storage.
Free L-methionine is known to protect methionine residues in proteins from oxidation …

The aseptic filling of drug products is carried out in pharmaceutical isolators that have been
sterilized. A commonly used method for achieving a high level of sterility assurance is …

Because the spike (S) protein of the severe acute respiratory syndrome coronavirus (SARS-
CoV) is the immunodominant antigen, the S protein and its receptor-binding domain (RBD) …

Methionine oxidation in therapeutic antibodies can impact the product's stability, clinical
efficacy, and safety and hence it is desirable to address the methionine oxidation liability …