Search results for "analysis" in Articles / App Notes
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…
Article
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…
Article
Unifying Continuous Biomanufacturing Operations
A 1998 analysis found that perfusion cultures can be in operation for up to six months (4). But that is just the upstream part of the process stream, so how long could end-to-end production processes …
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
This is commonly accomplished by nucleotide sequence analysis of the transgene-specific PCR products amplified from pooled cDNA.
• Assessment of integration patterns, which provides insight into p…