Formation of aggregates and particulates in biopharmaceutical formulation continues to be
one of the major quality concerns in biotherapeutics development. The presence of large …

Sterile injectable products are used extensively in health care. Patients, caregivers,
manufacturers, and regulators have an inherent expectation for safe and effective injectable …

The objective of this study was to compare different agitation stress methods (stirring in
Reacti VialsTM versus horizontal shaking) in their effect on protein destabilization, to assess …

Completely revised and updated, this third edition of Pharmaceutical Dosage Forms and
Drug Delivery elucidates the basic principles of pharmaceutics, biopharmaceutics, dosage …

The feasibility of size exclusion chromotography (SEC)–multiangle laser-light scattering as a
technique to investigate aggregation and degradation of glycosylated and nonglycosylated …

The development of a Microflow digital imaging (MDI) method to detect and monitor protein
particulates in a high concentration IgG1 monoclonal antibody formulation is presented. The …

Purpose: Studies were initiated to examine the effect of formulation and process variables
on the delamination process and also the influence of the glass manufacturing process …

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

Numerous presentations and articles on manual inspection of pharmaceutical drug products
have been released, since the pioneering articles on inspection by Knapp and associates …

Written by an expert in the industry, this text addresses the specifics of contamination,
including particle origination, characterization, identification, and elimination, with a special …