Search results for " validation" in Articles / App Notes
Article
New HiScale™ 10/40 for Scale-Down Studies
Cytiva is pleased to announced the new HiScale™ 10/40.
HiScale 10/40 column is especially suitable for scale-down studies used in, for example, viral clearance evaluation in downstream processing. …
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
An Analytical Approach to Biosimilar Drug Development
Providing analytical data on the comparison between a biosimilar and the reference product is a primary consideration in the development of biosimilars.
By Feliza Mirasol
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Article
Advances in Engineering of Protein-Based APIs
Advances in Engineering of Protein-Based APIs
New platform technologies, advanced modeling tools, and addressing patient needs are important developments.
By Cynthia A. Challener
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Article
Achieving Process Balance with Perfusion Bioreactors
“Users can eliminate most of the cleaning and validation steps that are associated with stainless-steel systems, saving both time and cost. They can also realize economic benefits with the reduction o…
Article
A Plastic Pipeline for Commercial Bioprocessing?
…configurations, faster changeover times, the reduction or elimination of cleaning steps and cleaning validation, and a lower risk of cross contamination are recognized as benefits of single-use syste…
Article
FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
More consistent and reliable production processes are critical for advancing innovative treatments.
By Jill Wechsler
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Article
A Look into the Future of Biopharmaceutical Quality
A Look into the Future of Biopharmaceutical Quality
Quality experts share insights on what the future may hold regarding regulatory quality requirements for biopharmaceuticals.
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Article
Optimizing Late-Stage and Commercial Cell-Culture Processes
• Modeling and leveraging platform knowledge; extensive platform knowledge is enabling more efficient process validation as one study can support multiple products. A platform culture process also ena…
Article
Fifteen Years of Progress: Biopharmaceutical Industry Survey Results
Bioprocessing lines/facilities need some downtime, including for switchovers, maintenance, new equipment installation and validation, staff training, and cleaning and sterilization of stainless steel …