Search results for " analyses"
Article
Predicting Progress in Protein Aggregation
“We have been successful to date in using such in silico analyses to address the issue of protein aggregation much earlier in the drug development process, which helps avoid potential problems through…
Article
Mechanistic Modeling: Current Advantages and Future Opportunities in Biopharmaceutical Process Development
Even assigning fraction analyses to the right time point in the chromatogram often needs extra work. Theses fraction analyses are currently needed to reveal the individual peak shapes of complex multi…
Article
The Importance of Partnering for Bioanalytical Studies
Additionally, most bioanalytical studies are moving towards mass spectrometry (MS)-based analyses, which involve instrumentation that is too expensive to acquire for many companies and require special…
Article
Moving PAT from Concept to Reality
Numerous at-line analyses evaluate host cell proteins (HCPs), DNA, viable cell density, bioburden, aggregates, product concentration, and particulates.
One of the greatest difficulties with many c…
Article
Understanding Validation and Technical Transfer, Part 3
Determine CQAs and perform appropriate risk analyses, not only with respect to the process, but for the patient who might use the product. Ishikawa diagrams and failure modes and effects analyses are …
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Release assays are often based on relative comparisons and parallel line/parallel logistic analyses with defined conditions for equivalence (28).
In one example, the dual specificity assay f…
Article
Tackling Analytical Method Development for ADCs
…ed when evaluating the systemic exposure of ADCs as part of drug pharmacodynamic and pharmacokinetic analyses, according to Kaur from Dalton.
One approach is to use hybrid techniques such as affi…
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
Chemical analyses
Chemical analyses were performed by Toxikon Europe N.V. in Leuven, Belgium. Extraction of solid materials (containers, films, and resins) was done by refluxing the material in di…
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Best Practices for Selecting a Top-Quality Cell Line
For instance, Fisch observes that secretory requirements can vary from protein to protein, and the genomic and transcriptomic analyses of the parent manufacturing cell lines helps to determine where t…
Article
Fiber-Based Protein A Chromatography for HTPD
Many analyses require purified proteins, and often substantial hands-on time is required for purification. The novel cellulose fiber technology (known as Fibro) may be used with ÄKTA™ chromatogra…