2009
DOI: 10.1016/j.tibtech.2009.06.006
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Roadmap for implementation of quality by design (QbD) for biotechnology products

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Cited by 356 publications
(218 citation statements)
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“…This would require the clear identification of a target profile (a specific disease, its subtype and the cellular target that needs to be modulated), an in-depth understanding of the biology, pathogenesis and, most importantly, shortcomings of the current line of management. This approach is well in line with previous observations that successfully translatable treatment modalities are more likely to arise from methods that are based on 'quality by design' [22] rather than starting from scratch. Thus, nanodrug delivery systems designed and developed based on the strong biology and clinical background of a specific target would have a much higher probability of success in translation as compared to the 'make it and screen it' approach.…”
Section: Introductionsupporting
confidence: 86%
“…This would require the clear identification of a target profile (a specific disease, its subtype and the cellular target that needs to be modulated), an in-depth understanding of the biology, pathogenesis and, most importantly, shortcomings of the current line of management. This approach is well in line with previous observations that successfully translatable treatment modalities are more likely to arise from methods that are based on 'quality by design' [22] rather than starting from scratch. Thus, nanodrug delivery systems designed and developed based on the strong biology and clinical background of a specific target would have a much higher probability of success in translation as compared to the 'make it and screen it' approach.…”
Section: Introductionsupporting
confidence: 86%
“…In contrast, attributes not impacting drug safety or efficacy would appear to be less of a concern. Focusing process control on critical quality attributes is the cornerstone of Quality by Design, an emerging paradigm in biotechnology development (10,11). As part of an effort to ascertain the impact of N-terminal heterogeneity on the safety and efficacy of therapeutic antibodies, studies were conducted to monitor pE formation in vivo.…”
mentioning
confidence: 99%
“…For example, the peptone and fructose concentrations could be adjusted dynamically from batch to batch, taking changes in the cost of raw materials into account. Furthermore, the DoE results could be used as part of the process development documentation necessary for regulatory compliance [28,29].…”
Section: High-throughput Screening and Doe Facilitate Rapid Model Buimentioning
confidence: 99%