Search results for "analysis"
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
Finally, a qualitative risk analysis or a formal failure mode effects and criticality analysis (FMECA) was conducted for each of the identified process parameters. The purpose of this assessment is to…
Article
Digitalization: The Route to Biopharma 4.0
The industry realizes that there is a limit on the number of experiments that is feasible, and, hence, extensive use of methodologies such as design of experiments and multivariate data analysis is be…
Article
Reimagining Affordable Biosimilars
In case differences are identified, their impact needs to be investigated through a detailed structure-function analysis. Biosimilars are approved only when there is no “meaningful clinical impact” (1…
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
Conventionally, methods that include peptide mapping, N-glycan analysis, capillary electrophoresis (CE), ion exchange chromatography, reversed-phase ultra-high-performance liquid chromatography (RP–UH…
Article
Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell Line
Second, better systems for collecting, storing, and analyzing process data have facilitated the application of multivariate data analysis (MVDA) to historical bioprocess data. These developments have …
Article
Evaluating Design Margin, Edge of Failure and Process
Unfortunately, this graphical representation of the design space is misleading and requires supporting analysis to be sure the set point within the design space will have high success rates.
Fig…
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Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
These recent innovations are better positioning exoglycosidases for routine use in analytical workflows that affect biologic drug analysis.
New problems, new solutions
An ongoing pharmaceutica…
Article
CoAs Help Secure the Supply Chain
I work in the warehouse and am responsible for maintaining the paperwork associated with incoming and outgoing shipments, including the certificates of analysis (CoA). Can you explain what should be o…
Article
Preclinical Evaluation of Product Related Impurities and Variants
This is followed by routine analysis using an array of tests (In vitro binding assays, in vitro potency assessment, pharmacokinetics, pharmacodynamics, toxicity assessment). The data from these studie…
Article
Improving PAT for Biologics
Using spectroscopy for the analysis of a complex broth of cells, where the active ingredient often remains in the cell bodies, is difficult, adds Ivo Backx, manager of business and project development…