Due to the impact on patient safety, particles have become a growing regulatory concern. West’s Analytical Services laboratory team has an intimate understanding of particle sources related to packaging and delivery systems, and can collaborate with customers to assist in testing.
West’s integrated analytical services around particle include particle counting/sizing, characterization and identification of particles. The laboratory team provides support to product development to ensure that the particle load coming from newly developed product is understood and characterized to ensure customers’ drug products are safe and effective when they reach the market.
West Analytical Services laboratory offers an integrated service that enables cost effective, efficient turnaround times for testing. Because the analytical lab is an extension of our product offerings, our analysts are intimately familiar with the composition of our products and potential particles related to the manufacturing process and the products.
West’s capabilities for particle characterization and identification include:
Glass delamination remains a significant concern for the storage of biologics. This is especially the case for large molecule formulations with high pH levels.
The particle laboratory can perform glass delamination testing using Differential Interference Contrast Microscopy (DICM) to determine if glass delamination has the potential to occur on selected glass.
In addition, the particle laboratory has the capability to perform particle counting and sizing for sub-visible and visible particles using: