Methods of rapidly and accurately assessing the chemical stability of pharmaceutical
dosage forms are reviewed with respect to the major degradation mechanisms generally …

Monoclonal antibodies (mAbs) are the most important family of biopharmaceutical
compounds in terms of market share. At present, 30 mAbs have been approved and are now …

The increased incidence of pure red cell aplasia with an Eprex formulation in uncoated
rubber stopper syringes. Background The incidence of pure red cell aplasia (PRCA) in …

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 …

Plant molecular farming (PMF) has been promoted since the 1990s as a rapid, cost-effective
and (most of all) safe alternative to the cultivation of bacteria or animal cells for the …

Abstract Background Subcutaneous administration of Eprex®(epoetin alfa) in patients with
chronic kidney disease (CKD) was contraindicated in the European Union between 2002 …

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 …

The Product Quality Research Institute (PQRI) is a non-profit consortium of organizations
working together to generate and share timely, relevant, and impactful information that …