Particulates in parenteral drug products are a concern in the pharmaceutical industry and require preventative action. Gretchen Shearer, McCrone Associates, looks at techniques for identifying protein aggregates.
The presence of protein aggregates or protein/silicone aggregates in therapeutic protein drugs is a potential problem.
Evidence suggests that protein aggregates can increase the immune response, which may result in undesirable events or outcomes. Parenteral drugs (drug products packaged for injection into the patient) are, therefore, required by regulatory agencies to be essentially free of visible particles, and there are limits for sub-visible particles. It is important to identify these particles to evaluate the potential hazards and to eliminate future particle problems.
Pharmaceutical and biopharmaceutical companies are becoming increasingly interested in obtaining a better understanding of the chemical composition, amount and size of protein/silicone aggregates.
There are several different types of protein aggregates, but for the purposes of this article, protein aggregates are defined as insoluble material that can be recovered from solution by filtration and can be observed in a product vial as a haze or as visible particulate (parenteral drugs are usually contained in glass vials, but syringes and ampoules may also be used).
Not yet a Subscriber?
This is a small extract of the full article which is available ONLY to premium content subscribers. Click below to get premium content on Manufacturing Chemist.
Subscribe now Already a subscriber? Sign in here.