Search results for " design"
Article
Fermentation for the Future
Recent developments at Boehringer Ingelheim
Boehringer Ingelheim has focused on establishing automated high-throughput systems for design of experiment-based, rapid bioprocess development. The com…
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Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
By establishing a correlation between input parameters (raw material chemistry and extrusion settings) and output parameters (leached level of bDtBPP and cell growth), both quality and control are des…
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Ligand-Binding Assays and the Determination of Biosimilarity
Selection and design challenges
One of the biggest challenges with LBAs is determining when they are appropriate. “LBAs are certainly easier for starting a development campaign, but recent regulat…
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What Drove Biopharma Development in 2014?
One of them is Quality-by Design (QbD). As federal agencies continue to push for proof of quality in biologics, there is increased interest in, and use of, QbD in pharmaceutical development and that t…
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Mechanistic Modeling: Does it Have a Future in Process Development?
What is the fundamental difference between mechanistic models and models based on Design of Experiments (DoE)?
Industry today is predominantly using statistical modeling – if they use modeling at a…
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High-Throughput Process Development in an Historical Environment
The workshop was followed by the plenary lecture given by Arne Staby of Novo Nordisk, in which he discussed mechanistic modelling versus – or complementing – Design of Experiments (DoE), and he also p…
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A Q&A With Dr. Anurag Rathore About the Future of QbD, Part I
Examples of such tools include high throughput process development, computational fluid dynamics, and use of advanced statistical approaches for designing experiments, analyzing data, and process cont…
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Single-Domain Antibodies for Brain Targeting
Identification and design of mutations that minimize the hydrophobic interface and direct selection from phage libraries have contributed greatly towards overcoming solubility and stability problems (…
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Concentrating Feed—an Applicable Approach to Improve Antibody Production
In the concentrated feed medium study, the original concentration is designated as 1X. The 1X medium was used as a control. Feed media with concentrations of 1X, 1.30X, 1.60X, 1.75X, 1.90X, and 2.50X …
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Global Expansion Shapes Drug Oversight
…tation on quality-by-design (QbD) components to new drug applications and supplements, an initiative designed to provide consistency and clarity to QbD policies.
At a London meeting in April, …