Search results for " characterization" in Articles / App Notes
Article
Host-Cell Protein Measurement and Control
Supplementary to HCP ELISA, traditional HCP separation and visualization methods, such as 1D and 2D sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE), remain useful tools for HCP ch…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
The purpose of this assessment is to provide a focus for the downstream process characterization work required to complete process validation Stage 1 (process design).
This initial risk assessm…
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
As molecules progress through the clinical phase and begin gearing up for commercial submissions, the amount of development and characterization may increase and many experiments must be repeated, add…
Article
Quality by design for biotechnology products—part 1
This knowledge is gained during development and grows with more manufacturing experience through process characterization, scale-up, technology transfer, and manufacture, as well as through increased …
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
One of the most important strategies manufacturers need to implement is investing significant resources early on for intensive product testing and characterization, including characterization of apher…
Article
Using Multiple Techniques in Biosimilar Analysis
The quality attributes that are assessed include higher order structure for macromolecules, which involves the characterization and comparison of secondary, tertiary, and quaternary structures.
The…
Article
Implications of Cell Culture Conditions on Protein Glycosylation
Techniques like this are, therefore, useful for comparative work but do not give much structural information for characterization of the molecules.
Figure 2: Stacked high pH anion-exchange chromato…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
In Part II, the preliminary risk levels of process parameters provided the basis of characterization studies based on design of experiments (DOE). Data from these studies were used to confirm the cont…
Article
Mechanistic Modeling: Current Advantages and Future Opportunities in Biopharmaceutical Process Development
This opens a wide range of model applications—from early-stage process development via process characterization to process monitoring and control.
GoSilico has developed the ChromX™ software. What…
Article
Good Manufacturing Practices: Challenges with Compliance
BioPharm: What are the struggles you have encountered when trying to comply?
Cohen (Lubrizol): The greatest struggle is achieving adequate characterization of the biologic material. The actual m…