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 Setting Up Bioprocessing Systems for Digital Transformation
Digitalization of bioprocessing operations, equipment, and facilities can improve workflow and output, but maintaining data integrity is a concern. By Feliza Mirasol The advancement of digit…

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 en…

Article Biosimilar Quality Requirements
Because protein products are, by their nature, complex molecules that are manufactured in living cells and later on purified through a variety of technologies, they will naturally have inherent lot-to…

Article Driving Improved Access to Biosimilars
Driving Improved Access to Biosimilars New guidance from FDA, including standards for interchangeability, is expected to speed development of biosimilars, but experts warn against oversimplifying ri…

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 Single-Use Technologies Prove Effective for Viral Vector Process Development
Serum is used to inactivate the trypsin, but lot-to-lot variability and the instability of the serum may fluctuate the degree of trypsin inactivation, and thereby result in less control over the host-…

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…