Particle Identification, CSI Edition: Unveiling Invisible Threats in Pharmaceutical Manufacturing
In this episode we are joined by Pascal Chalus, Lonza's Associate Director of Particle Identification, to uncover the intricacies of ensuring drug products are free from both visible and subvisible particles.
Imagine a simple injection – a vaccine, an IV fluid, or an antibiotic. Its clarity is not just aesthetic; it's a testament to safety and efficacy. But lurking beneath this clear surface could be subvisible particles, invisible threats that pharmaceutical manufacturers work tirelessly to eliminate. These particles, although unseen, can reduce the effectiveness of a medication, trigger unwanted immune responses, or even cause dangerous blockages in the bloodstream.
How do we combat what we cannot see? This question leads us into an insightful discussion with Pascal Chalus, who draws intriguing parallels between pharmaceutical particle identification and the forensic science popularized by the TV series "CSI." Just as forensic experts identify unknown substances to solve crimes, scientists like Pascal identify and analyze particles in medications, tracing their origins to ensure patient safety.
This field impacts everyone who has ever received an injection, taken a tablet, or swallowed a capsule – essentially, every one of us. Innovations in this field hold the promise of raising the bar for drug safety standards and therapeutic efficacy.
KEY TERMS:
Forensic chemistry is the field of chemistry related to legal investigations, paralleled in the podcast to the investigative methods used in particle identification.
Particle and foreign body identification is the process of detecting, analyzing, and identifying particles and larger bodies in pharmaceutical products to ensure their safety and efficacy for patient use.
A sub-visible Particle is a particulate that cannot be detected by the naked eye but can be identified through highly specialized equipment and procedures.
Protein aggregates are clusters of protein molecules that have bonded together, typically due to protein misfolding or denaturation. These aggregates can vary in size from a few nanometers to visible particles (half a millimeter).
Protein precipitates are larger deposits of proteins that have become insoluble and fall out of solution, forming visible particles.
Raw materials in pharmaceutical production are the basic substances from which drug products are made. If a particle or foreign body is found to come from the raw material, the entire batch must be rejected.