Search results for "doe"
Article
Essentials in Establishing and Using Design Space
Misconception One: Design of experiments is the same as design space
Design of experiments (DOE) is not the only method for determining a design space. Other methods can be used including know…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
Two separate design-of-experiments (DoE) studies were performed to identify and verify the optimum method conditions. The first DoE was conducted to explore and identify a preliminary set of chromatog…
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Quality by design for biotechnology products—part 1
A risk assessment should be performed to identify the process parameters that should be characterized using small-scale models and tools such as design of experiments (DoE). One approach commonly used…
Article
Optimization of an antibody polishing step
Optimal operating conditions for single units are found by altering just a few process parameters with Design-of-Experiment (DoE) procedures or high-throughput screenings. But what if DoE fails to fin…
Article
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
The International Council for Harmonization (ICH) defines QbD as a systematic approach that incorporates prior knowledge, results of studies using design of experiments (DoE), use of quality risk mana…
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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
…me’ (OFAT) to define individual factors, at least initially, and ‘design of experimentation’ (DOE) to look at multiple and interacting factors. The use of fractional factorial DOE as soon as is pract…
Article
Preclinical Evaluation of Product Related Impurities and Variants
A full factorial design of experiments (DoE) was performed to evaluate the effect of refold pH and cystine/DTT (15). In this study, levels of monomer, oxidized, and reduced GCSF were taken as product …
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
Design-of-experiments (DoE) methods can be useful in efficient experimental examination of these factors. During this activity, changes in the osmolality of the medium and generation of metabolic wast…