Search results for " experimental data"
Article
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media.
By Satish Mallya, Benjamin Lay, Lihong McAleer, Alexa…
Article
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Analytical exoglycosidases are transitioning from being largely academic tools to being s…
Article
The Importance of Partnering for Bioanalytical Studies
The Importance of Partnering for Bioanalytical Studies
Yakobchuk Olena/Stock.Adobe.com
Bioanalytical studies are an important aspect of biologic drug development that may necessitate…
Article
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Chi2 and residual values were used to evaluate the quality of fit between the experimental data and individual binding models. Plots of residuals indicate the difference between the experimental and r…
Article
Mechanistic Modeling of Preparative Ion-Exchange Chromatography
The first category, empirical modeling, is where the model is built using experimental data based on approaches such as the design of experiments (DOE). The second category is mechanistic modeling, wh…
Article
Modeling the Degradation of mAb Therapeutics
Concentration-based experimental data are fitted into model equations to calculate the apparent rate constants and predict the monomer degradation rate (17).
Aggregate sample prep and characteriza…
Article
Addressing the Complex Nature of Downstream Processing with QbD
Quality by design brings both challenges and benefits to the development of downstream processes.
By Susan Haigney
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Regulators have been en…
Article
Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
Optimization of each phase in a chromatographic cycle has a positive impact on productivity.
By Anna Grönberg
An important area of focus for the biopharma industry is the elucidation and dev…
Article
Concentrating Feed—an Applicable Approach to Improve Antibody Production
In this study, the authors evaluated different approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture. By raising the pH or by adding surfactants, the fe…
Article
Design of Experiments for Analytical Method Development and Validation
Design of experiment is a powerful development tool for method characterization and method validation.
Design of experiments (DOE) is a well-proven characterization approach within product…