Formulation and Quality – Biomolecular
2019 PharmSci 360
One of the major product quality challenges for injectable biologics is controlling the amount of protein aggregates and particles present in the final drug product. This presentation focuses on particles in the submicron range (defined here as below 2 μm in size based on technical capabilities), a population for which very little information is available. A cross-industry collaboration was undertaken through the International Consortium for Innovation and Quality (IQ Consortium) to address some of the analytical gaps in measuring submicron particles (SMP), developing best practices, and surveying the concentration of these particles present in 52 unique clinical and commercial protein therapeutics covering 62 dosage forms. Two emerging SMP characterization techniques, Nanoparticle Tracking Analysis (NTA) and Resonant Mass Measurement (RMM), were employed for this evaluation. The results from this cross-industry benchmarking study will be discussed. To the best of our knowledge, this is the largest study ever conducted to characterize SMP in late-phase and commercial products.