Commonly Asked Questions About Protein Aggregates
Pharmaceutical & Medical Packaging News - April 2012
Subvisible and visible particulate in parenteral drug products is an ongoing concern in the pharmaceutical industry. In particular, the presence of protein aggregates or protein/silicone aggregates in therapeutic protein drugs is a potential problem.
According to senior research chemist Gretchen Shearer at McCrone Associates Inc., the analytical division of The McCrone Group, Inc., because of the increased interested in obtaining a better understanding of the chemical composition, amount, and size of protein/silicone aggregates, concerns have been raised that protein aggregates can increase immune response and may produce undesirable events or outcomes. Below she answers some basic questions about protein aggregates and how to detect them.