Search results for " analysis"
Article
Regulatory Challenges in the QbD Paradigm
…ability and product quality through appropriate control strategies, documentation, data trending and analysis, risk assessment, and continuous review. It is a living system that incorporates gained k…
Article
QbD and PAT in Upstream and Downstream Processing
NMR could change the face of bioprocess development and monitoring because it provides access to component identity, plus quantitative data, rapidly and easily from a single analysis. NMR profiling ca…
Article
Quality by design for biotechnology products—part 1
One approach commonly used to facilitate a cause-and-effect analysis is the "fishbone" or derivative/one branch Ishikawa diagram (Figure 4). Such a diagram provides a graphical representation of the r…
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Article
Considerations in depth filter scale-up
Depth filters are widely used in the biopharmaceutical industry. They are typically made of a mixture of cellulose, filter aids, and a binder. These components can be milled and mixed in diffe…
Article
You are invited to attend DiPIA 2024
DiPIA, or Developments in Protein Interaction Analysis, is a global scientific conference hosted by Cytiva. We bring peers together from across the industry to share best practices, research, and new …
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Life cycle assessment of the protein A process in mAb manufacturing
Life cycle assessment (LCA), a systematic analysis of the environmental impact of a component or process from its material origin to its end-of-life deposition, is a common method for quantifying envi…
Article
Download your Mechanistic Modeling eBook
The ability to anticipate and model scale effects is another advantage of mechanistic modeling over multivariate data analysis (MVDA). Mild extrapolations are also covered in the mechanistic modeling …
Article
Top Process Development Trends for 2022 and a Look into 2023
We could see this clearly in an analytic oriented interview, which delivered useful information to many, describing real-time analysis tools implementation, and how these tools save time versus off-li…
Webcast
Recovery of Biological Products XIX
Case studies will be presented on harnessing digital technologies for manufacturability prediction, root cause analysis and adaptive control.