Search results for " process modeling"

Article Mechanistic Modeling of Chromatography: Opportunities and Challenges
What is mechanistic modeling in chromatography? Explore opportunities and challenges of an approach that can help make process development become faster, more scientific, and more reliable. Cl…

Poster Process economy modeling for viral vector production
Viral vectors, such as adenovirus, adeno-associated virus, and herpes simplex virus, can be used in cancer therapeutics and in vaccines for chronic diseases and are thus expected to become high-valu…

Article GE Healthcare Life Sciences and GoSilico Agree to Co-market ChromX™ Mechanistic Modeling Software
The agreement facilitates the adoption of ChromX™ by scientists and users of resins, columns, and chromatography systems into their downstream process-development workflows to accelerate development…

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 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 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 Determining Criticality, Part Two: DoE and Data-Driven Criticality
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle. T…

Article Being Thorough When Transferring Technology
Communication and taking the time to develop the process are key to successful transfer and scale up of biologics. By Susan Haigney Editor's note: The following is an extended version of the…

Article Continuous Manufacturing: A Changing Processing Paradigm
Apr 01, 2015 By Randi Hernandez BioPharm International Volume 28, Issue 4 Although continuous manufacturing is well established for bulk chemicals, complex automation and validation …

Article Understanding Validation and Technical Transfer, Part I
Understanding Validation and Technical Transfer, Part I This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry. Part 1 || Part 2 |…

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