All Quality by Design (QbD) articles
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ArticleQbD for biopharmaceutical product lifecycle management
Youngsun Kim and Busol Park from Samsung Biologics detail the benefits of using a Quality-by-design approach for biologics manufacturing.
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ArticleBeyond instruments: streamlining process technology implementation in biopharmaceutical manufacturing
Colleagues from biopharmaceutical company MSD reveal what it takes to fully realise the benefits of PAT implementation.
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NewsEnhancing intestinal drug delivery with Quality by Design
Research has highlighted a potential oral drug delivery approach using Quality by Design (QbD) principles to improve treatment of the colonic disease diverticulitis.
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NewsAchieving VLP continuous production with digital twins
Utilising a digital twin for an advanced process control strategy facilitates additional productivity gains of 20 percent at 99.9 percent reliability, the authors shared.
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NewsDriving QbD as a quality standard in drug development
To facilitate Quality by Design (QbD) in becoming a true standard approach for drug development, pharma should attend regulatory expectations and pursue innovative frameworks that guarantee high-quality levels, researchers urge.
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ArticleThe benefits of mass spectrometry for expediting biologics to patients
A key element of development for new molecular format biological products is to leverage the appropriate analytical tools to enhance product and process understanding throughout the development lifecycle. Here, Ian Anderson, Mostafa Zarei and Qifeng Zhang at Lonza highlight the benefits of using mass spectrometry technologies to accelerate and de-risk ...
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NewsHarnessing continuous improvement in the CAPA process
In a risk-based framework for implementing a corrective and preventive action (CAPA) process, a continuous improvement approach is proposed as a way to drive higher product quality and improve patient safety.
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NewsPaper reports on QbD in bilayer tablet development
A paper has stated that applying the quality by design (QbD) principle during development of bilayer tablets will “help improve product design while also enhancing the quality, safety, and efficacy of drug products”.
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NewsAutonomous PAT with digital twin integration reported
Autonomous biologics manufacturing with process analytical technology (PAT) “opens up a new frontier for aqueous two-phase extraction (ATPE)" in this sector, according to research.