Search results for " optimization" in Articles / App Notes

Article Impact of Media Components on CQAs of Monoclonal Antibodies
The complexity of composition of cell-culture media offers many challenges towards optimization of the individual media components (2–3). The formulation of optimal culture media for propagation of…

Article Mechanistic Modeling of Preparative Ion-Exchange Chromatography
However, development and optimization of a process chromatography step presents a major challenge due to the large number of process parameters that can affect the performance of the step. For example…

Article Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
…an be ensured by using quality-by-design and design-of-experiment techniques to address questions of optimization and reduce variability before implementing a drug substance/drug product sterile manu…

Article Digitalization: The Route to Biopharma 4.0
Such a setup offers multiple advantages, such as the ability to perform in-silco optimization as a means of gaining deeper understanding of the underlying physicochemical processes as well as reducing…

Article The Need for Advanced Process Modeling for New Therapeutic Biologics
…reas: -Design of experiments and statistical analysis -Deterministic models for optimization -Scale-up models linked to experimental data -Data modeling, anal…

Article The Evolving Role of Starting Materials in Cell and Gene Therapy
Scale-up/scale-out:Stability studies and cryopreservation/biopreservation methods optimization, logistics worked out. Manufacturing change validation/product comparability studies:Necessary t…

Article Best Practices for Selecting a Top-Quality Cell Line
Similarly, production cell lines must be well characterized so that scale-up from shake flasks to large bioreactors does not require extensive optimization. “Equally important,” stresses Fisch,…

Article Leveraging Computational Models of Glycosylation for Biopharma QA
Four QA application areas stand out: (i) data analytics, (ii) bioprocess characterization, (iii) cell line engineering/development, and (iv) manufacturing bioprocess optimization and control. Kine…

Article Single-use Bioreactors Have Reached the Big Time
The decision to use disposable bioreactors is now driven by commercial rather than technological considerations. By Cynthia A. Challener Single-use bioreactors available from various vendors…

Article Process Chromatography Selection for Downstream Processing Applications
Levison (Pall): With the introduction of continuous chromatography and optimization of flow through approaches to membrane chromatography, novel ligands, and base matrices may gain broader application…

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