CHALLENGES

Regulatory and market expectations constantly increase. Novel drug products such as cell and gene therapies have a very high value and therefore each dose is precious. With that, drug product manufacturers face increased pressure to minimize rejects of finished drug products. One aspect of this is controlling particulate matter. Particulate matter in finished drug products can come from a number of sources, including the ingredients in the drug product, manufacturing equipment and environment, or the components of the container closure system. This blog describes approaches to control and measure particulate matter.

The drug and packaging industries have always been extremely conscientious to ensure that anything added to a delivery device to improve performance (e.g., silicone oil used to coat the inner surface of a syringe barrel), does not affect a drug’s efficacy or safety. But what about the converse? How do we make sure that the drug, or more specifically its added excipients, does not affect the delivery system’s performance? The term excipient refers to any member of a broad group of surfactants, preservatives, tonicity agents, and buffers which formulation scientists take great care to balance in order to provide the drug, such as a therapeutic protein, in its most effective and deliverable state.

A point to consider in piercing a rubber stopper with a needle is formation of cores and fragments. Their presence in a drug is a critical concern. Both are considered particulate matter.