To ensure the stability of biologicals over their entire shelf-life, non-ionic surface-active
compounds (surfactants) are added to protect biologics from denaturation and particle …

Sterile product packaging systems consist of glass, rubber, and plastic materials that are in
intimate contact with the formulation. These materials can significantly affect the stability of …

Out of the plethora of chemical species extractable at low levels from the materials of
construction of single-use bioprocess containers, we have identified one particularly …

ABSTRACT A review is provided on the general topic of the compatibility of plastic materials
with pharmaceutical products, with specific emphasis on the safety aspects associated with …

In addition to degradation products, impurities, and exogenous contaminants, industries
such as pharmaceutical, food, and others must concern themselves with leachables. These …

Rubber stoppered glass vial systems are widely used as primary containers for storing and
delivering therapeutic protein products to patients. Addressing concerns and regulatory …

Structure elucidation of pharmaceutical impurities is an important part of the drug product
development process. Impurities can have unwanted pharmacological or toxicological …

Extractables and leachables are product‐related impurities that result from product contact
with components such as gaskets, stoppers, storage bags, cartridges, and prefilled syringes …

The increasing application of Single-Use Systems (SUSs) in pharmaceutical manufacturing
lines poses a potential risk of polymer-related impurities leaching into the process stream …

Purpose To investigate the cause of the observed instability of dulanermin in 100 ml
polyolefin (PO) infusion bags containing saline. Methods Diluted dulanermin in IV bags was …