Processing stresses on therapeutic proteins may cause formation of subvisible particles.
Different stress mechanisms generate particle populations with characteristic morphological …

Visible particles are a critical quality attribute for parenteral products and must be monitored.
A carefully designed, executed, and controlled drug product manufacturing process …

Subvisible particles (SVPs) are a critical quality attribute of injectable therapeutic proteins
(TPs) that needs to be controlled due to potential risks associated with drug product quality …

Suspensions of protein antigens adsorbed to aluminum‐salt adjuvants are used in many
vaccines and require mixing during vial filling operations to prevent sedimentation …

Subvisible particles may be encountered throughout the processing of therapeutic protein
formulations. Flow imaging microscopy (FIM) and backgrounded membrane imaging (BMI) …

Visible protein-like particle standards may improve visual inspection and/or appearance
testing practices used in the biotechnology industry. They may improve assay performance …

Innovative analytical instruments and development of new methods has provided a better
understanding of protein particle formation in biopharmaceuticals but have also challenged …

The presence of visible particles that are not anticipated to be present in drug products is
one of the most common causes of recalls and warning letters (Parenteral Drug Association …

As reported in the previous commentary (Ishii-Watabe et al., J Pharm Sci 2017), the
Japanese biopharmaceutical research group is promoting collaborative multilaboratory …

Industrial–SAFYBI como ámbito de participación y formación de referencia de los
Farmacéuticos y Bioquímicos relacionados con la industria Farmacéutica, toma el …