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QbD 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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Quality by Design (QbD)
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Beyond 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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Enhancing 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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Achieving 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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Driving 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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The 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 product…
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Harnessing 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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Paper 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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Autonomous 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.
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New strategy could improve generic drug quality assessments
Population pharmaceutical quality assessment could be used to improve the quality consistency of generic drugs, suggests study.
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The role of packaging in improving the bottom line for big pharma
Rich Quelch, Global Head of Marketing at DiD,1 explores how packaging can help pharma to cut costs, uphold high quality standards and improve health outcomes.
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Where now with quality by design?
Dave Elder discusses whether the goals of QbD have truly been met and questions whether the complex processes, lack of clarity and high costs have resulted in the promised global harmonisation.
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Overview of workflows and data approaches in bioproduction – an industry perspective
Downstream processing is an integral part of the production process of biopharmaceuticals and contributes quite significantly to the overall productivity and product quality, as well as to processing costs. Melanie Diefenbacher of Genedata provides a comprehensive overview of downstream processes, highlighting several challenges and the importance of investing into automation…
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Medicine delivery by drone – implications for safety and quality
Drones that transport medicines to emergency situations, urban environments or geographically-challenging locations are increasingly being utilised to improve delivery, however, there are few studies on their impact on drug stability. Here, Paul Royall and Patrick Courtney explore the implications of drone delivery on the safety and quality of medicines.
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ICH Q12: Technical and regulatory considerations for pharmaceutical product lifecycle management
The International Conference on Harmonisation (ICH) is drafting guidance for product lifecycle management (ICH Q12) – currently stage 2b, which requires application of the concepts of Quality by Design (QbD) to ongoing lifecycle management and change control. Dave Elder dissects the guidance and discusses considerations for industry professionals.
