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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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Quality by Design (QbD)
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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…
article
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.
article
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.
video
On-demand webinar: Developing an Isolator Filling Line Using a Quality Risk Management
Following the patent of the “Espresso” innovative infusion device, the Italian Biochemical Institute (IBI) “Lorenzini” commissioned Comecer to construct a new isolated filling line.
Whitepapers/App Notes/Posters
Whitepaper: Digital transformation in QA/QC labs
With international regulatory agencies calling for pharma companies to properly manage data integrity issues to ensure GMP compliance, Abbott Informatics demonstrates how their STARLIMS solutions can provide support for numerous systems.
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Routine mass analysis enables greater productivity in biopharma development
Biopharma developers and manufacturers need to know their molecules and understand their manufacturing processes better than ever before. In this article, Mike Wilson discusses the benefits of mass analysis in biopharma and the current challenges of adopting new technologies.
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European Pharmaceutical Review Issue 2 2019
This issue questions whether companies are sufficiently investing in regulatory intelligence software and what the potential consequences of Brexit might be for locations outside of the UK and EU. The issue also features articles on microbiology, formulation and biopharma, courtesy of our in-depth focus sections; as well as outlining the…
Whitepapers/App Notes/Posters
Whitepaper: Emerging trends in regulatory expectations
Regulatory expectations nowadays focus on harmonisation of global regulations. This whitepaper by PQE looks at current and emerging trends in regulatory expectations.
webinar
Applying quality risk management to develop an isolator filling line
11 February 2019 | By Particle Measuring Systems
Following the patent of the "Espresso" innovative infusion device, the Italian Biochemical Institute (IBI) "Lorenzini" commissioned Comecer to construct a new isolated filling line.
news
Pharmapack report predicts diversification of innovation leading to a rise in licensing and partnering
Pharmapack Europe has released a ‘European drug delivery and packaging’ report, ahead of the event’s opening which highlights, major challenges and opportunities for the industry in the year ahead...
article
The obstacle to developing an optimum placebo formulation for pharmaceutical freeze drying
Scale-up of pharmaceutical freeze-drying processes is cost and time consuming due to Quality by Design (QbD) requirements and novel compound costs or availability. The application of placebo formulations offers a promising way to improve drug development activities and save resources. Furthermore, placebos are used as a reference in clinical trials.…
product
Anne Marie details the benefits of ACD/Labs’ Luminata
Luminata enables assembly of a complete impurity control strategy for pharmaceutical development...
Whitepapers/App Notes/Posters
Scientific Poster: Raman spectroscopy technologies enabling scalable process control in bioprocessing
Bioprocesses require automated process control to make quality products consistently and efficiently...
article
Raman In-Depth Focus 2018
In this issue: the applications of vibrational spectroscopy for analysing the molecular component of a solid sample, and Raman as a fast-growing tool for PAT/QbD