Search results for " data interpretation"

Article Nurturing Knowledge from Disparate Data Streams
“Many of these techniques have traditionally been employed in the academic sector where data interpretation relies heavily on subjective manual review, and this is often difficult to translate to mach…

Article Successfully Moving Regulated Data to the Cloud
In light of recent FDA guidance on data integrity, the challenges and benefits of using the public cloud to deploy and use data management software are discussed. By Stuart Ward …

Article Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
By establishing effective management of data and knowledge, it will be possible to employ advances, such as artificial intelligence and synthetic biology, to their full potential in upstream bioproc…

Article Continued Process Verification for Biopharma Manufacturing
The authors discuss complications of implementing continued process verification and provide recommended approaches. Oct 1, 2014 By: Jeff Fleming, Robin Payne BioPharm International …

Article Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Advances in data interpretation The use of panels or arrays of highly defined exoglycosidase specificities to “sequence” N-glycans was first described in the 1990s (8). In this method, a series of…

Article Using Quality by Design to Develop Robust Chromatographic Methods
Quality-by-design principles can be used to understand chromatographic measurement system variability. Sep 2, 2014 By: Melissa Hanna-Brown, Kimber Barnett, Brent Harrington, Tim Graul, Jim…

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 Bioterminology: A Guide to the Biopharmaceutical Lexicon
Bioterminology: A Guide to the Biopharmaceutical Lexicon This lexicon was generated by the editors of BioPharm International magazine. Please feel free to email your suggestions for terms that s…

Article Evaluating E&L Studies for Single-Use Systems
• Many artifacts and analytical interferences were generated by strong/reactive solutions (as NaOH/NaClO), causing difficulties in the analyses and data interpretation; the use of strong saline/reacti…

Article Quality by design for biotechnology products—part 3
Guidance from the Quality by Design Working Group of the PhRMA Biologics and Biotechnology Leadership Committee on how to apply ICH Q8, Q8R1, Q9, and Q10 to biopharmaceuticals. By Taruna Arora, …

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