Search results for "qbd" in Articles / App Notes
Article
Handbook: Design of Experiments in Protein Production and Purification
Design of experiments (DoE) is a technique for planning experiments and analyzing the information obtained. The technique allows us to use a minimum number of experiments, in which we systematically v…
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
Along with the process lifecycle approach, other guides have been issued by FDA and the International Council for Harmonization (ICH), which include the concepts of quality by design (QbD), risk manag…
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Mechanistic Modeling of Preparative Ion-Exchange Chromatography
The authors believe the industry will see a rise in modeling during the next decade as the biotech industry attempts to institutionalize the principles of QbD and PAT and moves towards continuous proc…
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Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell Line
Use of a subspace model is a viable method to characterize process space variables and optimize process performance.
By Colin Jaques, Daniela Lega
Over the past decade, two improved capabili…
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Tackling Analytical Method Development for ADCs
He also notes that with the move to adopt a quality-by-design (QbD) approach for defining critical quality attributes for ADC, it is becoming easier to demonstrate the reproducibility of conjugation a…
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Early Communication with Regulators is Essential for SMEs
With SMEs gaining wider recognition as the powerhouse of research and innovation in Europe, regulatory agencies are urging companies to engage with regulators early in the drug-development process.
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2014 Manufacturing Trends and Outlook
However, almost 32% of the respondents have not implemented QbD. Reasons cited for not implementing QbD include a lack of guidance and direction from regulatory agencies (46.2%), no process or quality…
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Essentials in Establishing and Using Design Space
Knowledge of product or process acceptance criterion is crucial in design space.
Design space is generally considered to be the areas where the product or process parameters can be run safe…
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A Platform Approach for the Purification of Domain Antibodies (Dabs)
All purification steps were optimized by Design of Experiments (DoE), thereby supporting a Quality by Design (QbD) approach.
Using Capto L, Capto MMC ImpRes, and Capto adhere ImpRes media in …
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Filtration methods to overcome new challenges in viral safety
Read our article which summarizes the recent virus filtration regulatory changes in PDA Technical Report No. 41 and ICH Q5A, and outlines the detailed mechanisms governing effective virus filt…