Search results for " predictive modeling"

Article Robust Optimization, Simulation, and Effective Design Space
Jul 01, 2015 By Thomas A. Little, PhD BioPharm International Volume 28, Issue 7, pg 40–44 Approaches to the generation of process models, optimization techniques, and application of …

Article Polishing of Monoclonal Antibodies using Capto™ MMC ImpRes in Bind and Elute Mode
A rapid procedure to establish a robust second step in bind/elute (B/E) mode for the purification of a MAb using Capto MMC ImpRes has been developed. This study presents results from optimization …

Article Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
The objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions on aggregation and subvisible particle formation of a monoclonal antibody solution (mAb-A; IgG1) u…

Article Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell Line
Use of a subspace model is a viable method to characterize process space variables and optimize process performance. By Colin Jaques, Daniela Lega Over the past decade, two improved capabili…

Article Predicting Progress in Protein Aggregation
Techniques to enable the design and formulation of stable, protein-based therapeutics. In silico analysis and the evaluation of formulability, aided by new analytical tools such as hydrogen deut…

Article Use of Multivariate Data Analysis in Bioprocessing
Apr 06, 2015 By Anurag S. Rathore, Sumit K. Singh BioPharm International The ever increasing demand of biotherapeutics, together with the pressure to contain healthcare costs have motiva…

Article Essentials in Establishing and Using Design Space
Knowledge of product or process acceptance criterion is crucial in design space. Design space is generally considered to be the areas where the product or process parameters can be run safe…

Article Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
The author applies the continuum of criticality to develop the process control strategy and move through Stages 2 and 3 of the new process validation lifecycle. With the most recent FDA …

Article Bioterminology: A Guide to the Biopharmaceutical Lexicon
Bioterminology: A Guide to the Biopharmaceutical Lexicon This lexicon was generated by the editors of BioPharm International magazine. Please feel free to email your suggestions for terms that s…

Article QbD Improves Cell-Culture Process Control
However, using a quality-by-design (QbD) approach that employs predictive modeling can improve the quality of end product as well as the efficiency of the bioprocess. Real-time quality control …

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