Search results for "analysis"
Article
Ensuring Viral Safety of Viral Vaccines and Vectors
Extraneous vesiviruses, however, have recently appeared in bioreactors (2–5), and porcine circovirus type 1 (PCV-1) contamination of oral rotavirus vaccines was first reported by a metagenomics analys…
Article
The Challenge of Disruptive Technologies in Bioprocessing
“Advanced automation also involves the use of trend analysis and correlations between ‘simple’ measurements and ‘complex’ quality attributes,” he says.
“This all helps to lower the cost of the …
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…
Article
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…
Article
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…
Article
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…
Article
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…