Search results for " variability"

Article Optimizing Late-Stage and Commercial Cell-Culture Processes
Cell-culture process innovations include platform processes with high productivity and chemically defined culture media, which have helped to reduce process variability and complexity, improve efficie…

Article Understanding Validation and Technical Transfer, Part 2
Understanding Validation and Technical Transfer, Part 2 A validation plan developed to support a process unrelated to bio-pharmaceutical manufacture is applied to biopharmaceutical processes and sys…

Article Understanding Validation and Technical Transfer, Part I
Codification of validation expectations and requirements was intended to reduce that variability. The 1978 CGMP regulations (4) discussed validation in terms of automatic, mechanical, and elect…

Article Preclinical Evaluation of Product Related Impurities and Variants
This may be attributed to the complexities related to the use of cell lines, media formulation, and other bioprocessing steps that are prone to variability to varying degrees (4). The inherent …

Article Reliability Rooms and the Move to Proactive Supply Chain Management
Success demands consistent discipline and rigor from supply chain and manufacturing operations, as well as programs and procedures that mitigate risk and variability. This article discusses effo…

Article Evaluating Surface Cleanliness Using a Risk-Based Approach
Evaluating Surface Cleanliness Using a Risk-Based Approach Rinse sample analysis or visual inspection can be correlated to surface cleanliness to replace surface sampling. By Elizabeth Rivera…

Article Unifying Continuous Biomanufacturing Operations
Mechanistic modeling may be key for purification processes to be able to react to the inherent variability of cells upstream that result from perfusion, the Karst team demonstrated. Mechanistic modeli…

Article Automating Bioprocesses
Automation of stainless-steel systems and single-use systems differs in complexity. By Jennifer Markarian Both upstream and downstream biopharmaceutical processes have conventionally used st…

Article Managing Risk in Raw Material Sourcing
By Agnes Shanley Choosing excipients and suppliers for pharmaceutical formulations requires a clear understanding of product requirements; material properties; product, process, and material varia…

Article Advancing Single-Use Technology Through Collaboration
By working together to harmonize the highly variable steps within the biopharmaceutical manufacturing process, both end users and suppliers are making strides toward the efficiency and integrity of …

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