Search results for " stability"
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
The cell-culture process and media are known to have a significant effect on the expression and stability of therapeutic products as well as their critical quality attributes (CQAs) including glycosyl…
Article
Process Chromatography Selection for Downstream Processing Applications
Some factors companies may consider when selecting a separation technology include the stability of the biologic, buffer compatibility, and ease of scale-up. In this roundtable discussion, industry ex…
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Detecting Protein Aggregates and Evaluating their Immunogenicity
There is currently no statutory requirement for the presence of protein aggregates in the subvisible range, so the ultimate goal is “protein stability with the lowest possible level of aggregates,” as…
Article
Reimagining Affordable Biosimilars
Raman, Fourier transform infrared, and circular dichroism (CD) spectroscopy are now being increasingly used for fingerprinting biomolecules using PTMs like glycosylation and stability parameters as ba…
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The Importance of Partnering for Bioanalytical Studies
The general assessments for method validation consist of accuracy, precision, selectivity/specificity, linearity, robustness, and stability.
Depending on the type of assay, certain parameters ma…
Article
Achieving Process Balance with Perfusion Bioreactors
Ensuring process stability
The longer process durations can be more challenging for single-use bioreactors. “The industry has called for continued innovation in the applications of single-use tech…
Article
Understanding Validation and Technical Transfer, Part 3
Acceptance criteria are established based on data obtained from preclinical and clinical studies as well as from demonstration lots used to show manufacturing consistency and from stability studies. I…
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Platform Technologies Improve Protein Expression
…cell line, expression plasmid design, cultivation medium, growth conditions, equipment, scalability, stability, and matching purification capability, to name but a few. Primary drivers to the develop…
Article
Critical Quality Attributes Challenge Biologics Development
While CQAs of small-molecule drugs can affect the purity, strength, drug release, and stability of a drug, the complex nature of biologics can create additional quality attributes that can affect the …
Article
Establishing Acceptance Criteria for Analytical Methods
Reporting Stability
A stability study on critical reagents such as standards and/or bulk materials has no acceptance criteria; however, the study should indicate the expiry of pre-mixe…