Raw material variability: the need for deeper process understanding
Read about one source of variation, chromatography resin raw materials.
Risk assessment: when to study chromatography resin variability
Learn how to identify which parameters and interactions to focus on during process characterization studies.
Application: studying resin variability
Learn how Process Characterization Kits can be used to assess the potential impact of resin ligand density variability
Addressing the complex nature of downstream processing with QbD
Get Gunnar Malmquist’s insights from this interview by BioPharm International
Manufacturing process understanding and control help to ensure biologic delivery
Understanding and controlling raw material variation in cell culture media
Manage variability through advanced analytical methods and risk-based assessment