Search results for " optimization"

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…

Article Selecting the Right Viral Clearance Technology
Literature data can help in evaluating and planning effective optimization of these steps. A matter of balance Implementation of viral clearance steps must be accomplished without affecting th…

Article Determining Criticality, Part Two: DoE and Data-Driven Criticality
Optimization (central composite, Box-Behnken). To generate response surfaces and illustrate second-order (quadratic) relationships between process parameters and CQA. This analysis allows optimal se…

Previous PageNext Page