Search results for " analysis" in Articles / App Notes
Article
Understanding Validation and Technical Transfer, Part 3
Maintaining the validated state of control through the product lifecycle extends from product development, through process and analytical development, to process and analysis implementation and commer…
Article
Biopharma Says It Has an Evolution in New Technologies and Processes
Exhibitors announced new chromatography systems for pilot- and small-scale production, new resins, mixing systems, kits for glycan analysis and mycoplasma detection, filters, and sensors.
As bi…
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Reliability Rooms and the Move to Proactive Supply Chain Management
Through data collection and analysis, key themes were identified related to timeliness, certain countries’ response rates, and the quality of documents.
A cross-functional team from quality, cus…
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Managing Residual Impurities During Downstream Processing
“USP was very helpful in introducing mass spectrometry as a tool for the qualitative analysis of residual HCPs,” comments Tissot. She would like to see, however, USP define mass spectrometry as a sol…
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Being Thorough When Transferring Technology
A supplementary process risk identification/assessment using ‘cause and effect’ and/or failure mode and effect analysis tools within the recipient site would confirm the capability of the transferred …
Article
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
Comparative analysis through clinical evaluation is also required for production of the biosimilar product.
Immunogenicity is another important aspect of biosimilarity. Because it is not possible …
Article
Single-use Bioreactors Have Reached the Big Time
Recipe functions and data acquisition and analysis capabilities, including most recently multivariate data analysis, allow for effective monitoring of bioprocesses and provide greater confidence in th…
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Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
Thermal analysis of protein samples was performed by modulated differential scanning calorimetry. The freezing rate in a single freeze-thaw cycle had negligible impact on protein aggregation when fast…
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Resolving a bottleneck in screening and characterization of recombinant antibody fragments using Biacore 4000
A subset from this screen was selected for analysis with the 2-over-2 kinetics approach. This method provides rapid screening in combination with data-rich selection of fragments with high affinity an…
Article
Vaccine Development Faces Urgency and Challenges
The campaign has helped move more vaccine candidates through clinical testing to market approval, according to an analysis in the February 2016 special issue on vaccines in the journal Health Affairs …