Search results for " DoE"
Article
Essentials in Establishing and Using Design Space
DOE design and scale considerations in the DOE
DOE generation needs to be linked to the risk assessments and business objectives. Full-factorial or D-Optimal custom designs are most comm…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
The first DoE was conducted to explore and identify a preliminary set of chromatographic conditions for further verification. The second DoE was conducted to verify conformance of the method to the AT…
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Quality by design for biotechnology products—part 1
Part 2 covers the use of DOE to define the design space, unique considerations for process development for biopharmaceuticals, the establishment of a control strategy, and the placement of QbD informa…
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Optimization of an antibody polishing step
But what if DoE fails to find robust process conditions? This article shows how to achieve higher yields using mechanistic models to optimize an antibody purification process.
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Insider Recommendations for Getting Started with Mechanistic Modeling of Chromatography
Of course, to assist in that, so Cytiva does provide extensive training, tutorial files, help texts, and, of course, user guides and consultancy services to help meet this skills gap.
Malmquist…
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Addressing the Complex Nature of Downstream Processing with QbD
In such cases, a few optimally designed experiments are executed to understand the sensitivity of the specific molecule to the unit operation and the platform parameters being implemented, and a full …
Article
Increase Efficiency in Experimentation with Design of Experiments
Learn more about how to benefit from DoE study setups from the handbook Design of Experiments in Protein Production and Purification.
Article
Impurity Testing of Biologic Drug Products
The use of fractional factorial DOE as soon as is practical allows for a more rapid and robust method development.
Validation would be accomplished in a phase-appropriate manner. The guid…
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Preclinical Evaluation of Product Related Impurities and Variants
The results of the DoE were used to identify conditions, which will result in formation of high level of one of the product related species under consideration. For example, the cystine/DTT ratio is g…
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
The authors review how media components modulate the quality of monoclonal antibody products.
By Anurag Rathore, Rajinder Kaur, Dipankar Borgayari
Recombinant protein products have…