Search results for " mechanistic modeling"

Article Mechanistic Modeling of Preparative Ion-Exchange Chromatography
For complex unit operations such as process chromatography, mechanistic modeling can assist in developing a systematic approach for process development, monitoring, and control. Models can also be jud…

Article Mechanistic Modeling: Does it Have a Future in Process Development?
Most often, the DoE approach is preferred based on a cost-benefit evaluation where the time consumption, complexity, and lack of know-how on how to deploy are found too extensive when using mechanisti…

Article Utilization of Mechanistic Modeling to Improve Process Development
Utilization of mechanistic modeling of unit operations, based on scientific and physical understanding of the process, is one of these approaches. Improved computational resources in the past decade h…

Article Leveraging Computational Models of Glycosylation for Biopharma QA
This disparity may arise from the use of specialized software and the perceived need for expert user input associated with mechanistic modeling. Despite these challenges, mechanistic models are, conce…

Article Determining Criticality, Part Two: DoE and Data-Driven Criticality
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle. T…

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 Modeling and Miniaturization: Key Topics at Successful HTPD Conference
Ottens reviewed how knowledge-based chromatographic process development based on mechanistic modeling will become more important and more utilized in the industry in the coming years. He also emphasiz…

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 Unifying Continuous Biomanufacturing Operations
The success of a truly integrated continuous processing platform relies on the collaborative efforts of upstream and downstream specialists. By Randi Hernandez When human cells travel througho…

Article Quality by design for biotechnology products—part 2
Second in a three-part series that discusses the complexities of QbD implementation in biotech development. By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman…

Next Page