Detection and characterization of particles in the visible and subvisible size range is critical
in many fields of industrial research. Commercial particle analysis systems have proliferated …

Particles in biopharmaceutical formulations remain a hot topic in drug product development.
With new product classes emerging it is crucial to discriminate particulate active …

Glass delamination is characterized by the dissociation of glass flakes from the glass
surface. Since glass delamination is time dependent, 5 vial types were investigated to …

Visible particle identification is a crucial prerequisite step for process improvement and
control during the manufacturing of injectable biotherapeutic drug products. Raman …

A new type of lamellae-like particles was observed in protein based liquid therapeutic
protein drug product (DP) packaged in standard (STD) and delamination controlled (DC) …

This chapter discusses the important elements of extractables and leachables, with which
those in the pharmaceutical industry should be familiar. Drug products, biological products …

A previously unreported particle type was observed during routine visual vial inspection of a
liquid drug product and suspected to be the result of vial delamination. Delamination is the …

Parenteral container closure systems are in direct contact with the drug product formulation
and can significantly impact the product quality. The interaction between the drug product …

Primary packaging containers used for the storage of parenteral drugs are designed to
protect the medicinal product from the environment to ensure patient safety. Mainly …

The field of formulation and stabilization of protein therapeutics has become rather
extensive. However, most of the focus has been on stabilization of the final drug product …