June 6th 2025
ICH Q6B provides expectations and a clear framework for the structural characterization of biopharmaceutical products.
Analytical Procedure Lifecycle Management: Current Status and Opportunities
Drawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.
Three Examples of Hypothetical ATPs
Three hypothetical analytical target profiles (ATPs) are provided, reflecting the current thinking of the the European Federation of Pharmaceutical Industries and Associations Analytical Lifecycle Management Team.
Multiple Attributes Monitoring: A New Phase in PAT for Biopharmaceuticals
November 15th 2018By reducing the number of assays needed and allowing product quality attributes to be measured end to end, MAM promises to allow users to gain product and process understanding much sooner than they could in the past, and to ensure quality and safety in a more efficient, streamlined way, throughout the product life cycle.
The Impact of Vortexing on the Particle-Size Distribution of Pharmaceuticals
November 15th 2018If a vortex mixer produces too much energy during sample preparation for particle size analysis, the size and morphology of particles can change. A study compares the applied shear to sample suspensions of ibuprofen to observe the effects of applied shear on the particle size distribution.