Search results for " methods" in Articles / App Notes
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
Different techniques and particle-detection methods for measuring aggregation at various sizes produce different results that may or may not correlate with one another. “All of this is caused by the d…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
Several computational statistical methods are available for analysis of process reliability. Each of these requires specialized statistical software.
These methods include:
…
Article
Leveraging Data for Better Biopharmaceutical Process Control
Biopharmaceutical companies are starting to use PAT in more advanced development and even some manufacturing work, while methods are also moving downstream. Francisca F. Gouveia, a biopharmaceutical p…
Article
Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
But because the chosen methods focused primarily on downstream virus removal or inactivation instead of strategic sourcing of lower-risk starting materials, the efforts had little effect on serum-free…
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
During development and quality control, a range of analytical technologies are used to characterize biotherapeutic drugs, including methods to analyze their structural integrity and activity. Target/l…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
Cell culture was performed using numerous methods, including roller bottles and stirred tank bioreactors operated in perfusion, batch re-feed, or fed-batch mode (1).
Starting in 1986 with the lic…
Article
Assessing Manufacturing Process Robustness
Documents and methods
Based on the 2011 FDA process validation guidance and relevant ICH guidances, this assessment method requires the use of analytical and interpretive methods based on stan…
Article
Eliminating Residual Impurities Starts with a Strategic Plan
It also allows the development of an optimal process with a suitable control strategy and test methods in a timely fashion.
The implementation of a risk-based strategy for the testing of residua…
Article
Unifying Continuous Biomanufacturing Operations
Through continuous manufacturing methods upstream, engineers have been mastering the ways to support the growth of cells to desired volumes while preserving cell viability. Downstream continuous purif…
Article
Elucidating Biosimilars Characterization
…out the importance of characterization studies during biosimilars development and related analytical methods.
The complex nature of biosimilars
BioPharm: Why are biosimilars not consid…