Search results for " lot-to-lot variability"

Article Raw Material Variability
The biopharmaceutical industry is developing a new approach to controlling variability in raw materials. It would seem that raw materials used in bioprocessing operations are a relatively straig…

Article Addressing the Complex Nature of Downstream Processing with QbD
Quality by design brings both challenges and benefits to the development of downstream processes. By Susan Haigney natali_mis/Stock.Adobe.com Regulators have been encourag…

Article Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
The author applies the continuum of criticality to develop the process control strategy and move through Stages 2 and 3 of the new process validation lifecycle. With the most recent FDA …

Article A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
The analysis revealed that near-infrared spectra of different soy lots contain enough physicochemical information about soy hydrolysates to allow the identification of lot-to-lot variability as well a…

Article Purification Strategies to Process 5 g/L Titers of Monoclonal Antibodies
Differences in DBC resulting from packing or resin lot-to-lot variability are considered negligible. Protein A resins all demonstrate higher DBCs with decreasing flow rate, although the slope of th…