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…
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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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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…