Search results for " characterization"
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…
Article
Modeling the Degradation of mAb Therapeutics
Aggregate sample prep and characterization
To monitor and understand the aggregation mechanism and its behavior in proteins, a model protein (mAb) was chosen with an isoelectric point (pI) of 8.5.…
Article
Understanding Validation and Technical Transfer, Part 3
The product specification is established through evaluation of the process design, process capability determinations, and characterization of the product. Acceptance criteria are established based on …
Article
Analysis of Glycosylation in Biosimilars
A step-wise process is used to characterize glycans and understand the functioning of a molecule for biosimilar development.
The structures of protein drugs such as monoclonal antibodies are mad…
Article
Tools for Continuous Bioprocessing Development
Could perfusion microbioreactors bring more agility to biomanufacturing?
By Rajeev J. Ram
In semiconductor manufacturing, for example, a thorough understanding of process variation allows co…
Article
Application of Quality by Design to Viral Safety
Risk analysis and scientific characterization identify those components that will have the biggest effect on process consistency and CQA.
Identification of a multivariate design space in which dat…