Search results for " process qualification"

Article Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
Stage 2: Criticality and process qualification The FDA Process Validation Guidance requires qualification in that “utilities and equipment are suitable for their intended use” as part of Stage 2 (…

Article QbD and PAT in Upstream and Downstream Processing
To gain perspective on the implementation of quality by design (QbD) and process analytical technology (PAT) in biopharmaceutical processing, BioPharm International spoke with Clinton Weber, as…

Article The Lifecycle Change of Process Validation and Analytical Testing
With additional material understanding and a greater development focus, there is tremendous potential to reduce the process qualification burden and enhance process robustness throughout the lifecycle…

Article Assessing Manufacturing Process Robustness
…tinued monitoring and sampling of CPPs and quality attributes is at the level established during the process qualification stage until sufficient data are available. An ongoing progra…

Article Single-Use Technologies Prove Effective for Viral Vector Process Development
The benefits of single-use technologies for upstream viral-vector processes clearly outweigh their disadvantages. Cynthia A. Challener  Upstream viral-vector processes can have sig…

Article Continued Process Verification for Biopharma Manufacturing
In general, the nature and extent of CPV should be aligned with the outcomes of process qualification by focusing attention on aspects of processing that are most important to determining the quality …

Article Leveraging Data for Better Biopharmaceutical Process Control
Leveraging Data for Better Biopharmaceutical Process Control The need to improve and understand processes is moving PAT and more advanced control strategies beyond the lab into manufacturing and dow…

Article Aseptic Processing: Keeping it Safe
By Randi Hernandez, BioPharm International Humans represent the greatest risk for microbial contamination in an aseptic process. Aseptic processing has garnered some increased scrutiny…

Article Using Digital Twins to Model Process Chromatography
Mechanistic models provide process understanding for developing robust manufacturing processes and for scale up and tech transfer. By Jennifer Markarian A digital twin is a model of a proces…

Article The Importance of Process Intensification and PAT for Achieving Real-Time Release
Creativity and collaboration are required to overcome complex method development challenges. By Kelvin H. Lee and Mark Lies …

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