Particles are a critical component of all biologic, cell, and gene therapies.
Subvisible particles matter. They matter a lot. Subvisible particles are generally considered anything smaller than about 100 micrometers – just smaller than what the human eye can see. However, they can have a big impact even though they are small. They are the #1 cause of drug product recalls. These small particles can be dangerous to patients. They are much larger than what can fit through the capillaries in the human body (~10 micrometers), so just imagine what could happen if one of these particles entered and clogged capillaries in the brain or lungs. Plus, these particles can elicit a dangerous immune reaction in some patients.
All injectable drugs face strict requirements to be virtually free of subvisible particles. The problem is, however, that subvisible particles are very hard to see and count. Some particles, like plastic or fibers, can be easily seen with a microscope, but what if the particle is the drug itself? When the drug forms particles, they often form in ways that make them difficult to see. They can look almost identical to the liquid that they are in. Even worse, with some of the newest life-saving cell therapies, the drug itself is supposed to be a particle (a cell). How do you tell a good particle that should go into a patient from a harmful particle that should not go into a patient?
Fortunately, Halo Labs has the Aura™ line of instruments. These are the first systems that allow particles to be tested both early in development and later during quality control. The Aura systems can determine if a particle is the result of the drug itself, an ingredient in the liquid crashing out of solution, an external contaminant, or even a cell.
According to the FDA, drug manufacturers can’t just rely on the minimum standards when they release a product. They need to make sure that their products are truly safe and so particles need to be fully characterized throughout the entire development cycle. Halo Labs allows drug companies to make critical therapeutics safer and reduce their development time to help patients in need.