Search results for " design" in Articles / App Notes
Article
Biopharma Advances Demand Specialized Expertise
This reorganization was designed to enhance quality drug assessment by realigning several elements of the preapproval and surveillance inspection process. Integrating risk-based review, GMP inspection…
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Quality Systems Key to Lifecycle Drug Management
In most situations it’s easier to design a new drug than to update existing analytical methods and technology, noted Ganapathy Mohan, head of global CMC at Merck, Sharp and Dohme. Global approval of a…
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Use of Multivariate Data Analysis in Bioprocessing
The increasing use of MVDA has also been fueled by the increasing acceptance of quality by design (QbD) and process analytical technology (PAT) among regulators and the biotech industry. Implementatio…
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The Bullish Outlook for Biosimilars
Unique to the US, FDA will designate these follow-on biologics as either ‘biosimilar’ or ‘interchangeable biosimilar’ based on the level of evidence submitted. While there is still plenty of uncertain…
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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…