Search results for " characterization" in Articles / App Notes
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…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
These reasons force sponsors to initiate extensive process characterization studies and to lock the production processes early in the clinical development program (41).
One new approach to genera…
Article
Current Techniques and Challenges Presented in Scaling Between Bioreactors
These tools require high quality characterization data of the use bioreactors. Stainless steel bioreactors merge with the described tools which may be a challenge for the upcoming years. However, when…
Article
Assessing Manufacturing Process Robustness
…ty can be detected, as recommended by FDA process validation guidance
closure of the characterization gaps that were not addressed during early product development and to meet QbD sta…
Article
Technology Innovations Improve Process Chromatography Performance
Although significant work has been done in upstream bioprocessing to remove bottlenecks through the implementation of single-use technologies, better characterization of raw materials, and the use of …
Article
Eliminating Residual Impurities Starts with a Strategic Plan
Depletion of such molecules in the final process design should, however, be confirmed during process characterization and process validation.
Many regulations
There are several relevant…