The number of therapeutic monoclonal antibody in development has increased tremendously
over the last several years and this trend continues. At present there are more than 23 …

Formulation of a new drug product with excipients, that have been previously added to an
approved injectable product, may save pharmaceutical companies developmental time and …

This review article is a current survey of excipients used in approved injectable products.
Information provided includes concentration ranges, function, frequency of use, and role in …

Proteins generally will tend to aggregate under a variety of environmental conditions in
comparison with small drug molecules. The extent of aggregation is dependent on many factors …

Protein aggregation is one of the key challenges in the development of protein biotherapeutics.
It is a critical product quality issue as well as a potential safety concern due to the …

This paper investigates the microneedle-mediated in vitro transdermal delivery of human
IgG as a model protein and demonstrates its applicability to deliver a monoclonal antibody. …

Production of biologics is an expensive process, and to optimize capacity use, bulk protein
solution is often produced in manufacturing campaigns. It is converted into drug product …

The objective of this study was to investigate the behavior of lactate dehydrogenase (LDH).upon
freezing and thawing, alone or in the presence of several selected cryoprotectants. Also,…

The purpose of this work was to establish ultrasonic storage modulus (G′) as a novel
parameter for characterizing protein-protein interactions (PPI) in high concentration protein …

The term pharmaceutical excipient or additive denotes compounds that are added to the
finished drug product for a variety of reasons. Most often excipients are major components of …