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 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 Monitoring and Control of Inline Dilution Processes
He notes that metering pumps, particularly those that are servo controlled, more accurately and consistently blend buffer constituents to the exact molecular ratio that was defined in the original pro…

Article Automating the Biomanufacturing Process
As automation in biomanufacturing becomes more important, so does the need to integrate process data. By Feliza Mirasol  unlimit3d/Stock.Adobe.com Biomanufacturing proc…

Article Technical and Process Economical Aspects of Using Capto™ Q and ReadyToProcess™Adsorber Q in mAb Polishing
Increasing product titers in upstream cell culture processes pose challenges to downstream purification processes. For efficient operations, downstream purification needs to be able to handle high p…

Poster Scale-up and process economy calculations of a dAb purification process using ready-to-use products
Purification of a domain antibody (dAb) in a chromatography capture step was successfully scaled from laboratory to pilot scale using ready-to-use equipment and ready-made buffers. The scaled-up pro…

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