Formulation and Quality – Biomolecular
2019 PharmSci 360
Particulates in parenteral drug development have always been a serious issue. In biopharmaceuticals, the issue is compounded by reported impacts of aggregates and particulates on the product’s efficacy, safety, and immunogenicity. FDA regulations strongly recommend in-depth characterization of the identity and quantity of particles in protein therapeutics. Particle concerns are increasingly common in FDA submissions, and in some cases, particle matters have resulted in drug recalls.
Image quality is extremely important when characterizing, identifying, and differentiating particles like protein aggregates, silicone oil droplets, air bubbles, and other contaminants, and is also essential for accurate sizing. “Blurry” particles produce a relatively lower count and concentration compared to “sharp” particles. Poor characterization creates a wider variation in measurements, and can lead to less accurate results and lower statistical confidence.
FlowCam represents a powerful tool with unique features for detection, counting, and characterization of protein aggregates and other particles in parenteral drug formulations.