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European Biopharmaceutical Review

QbD in Action

Humans are living increasingly longer due to continuous delivery of new chemical and biological entities (NBEs) from the pharmaceutical industry as tested and approved drugs. Unfortunately, this does not necessarily mean we are living healthier lives. With preventable issues on the rise – such as obesity, where 13% of the world’s adult population are now classed as overweight, or our dependency upon antibiotics giving rise to antibiotic resistance – some will debate this. However, there is a growing trend to deliver drugs that will contribute to a healthier society through the reduction of diseases, including cancer, cardiovascular disease, infectious diseases and neurological disorders, to name but a few.

NBEs are considerably more complex than traditional small molecule-based drugs due to their production by living cells and being hundreds of times larger and inherently more complicated to manufacture, so the existence of numerous regulatory guidelines is no surprise. These serve to ensure safety as well as efficacy and revolve around the continuous monitoring of key critical quality attributes (CQAs) throughout the drug development lifecycle. Routine characterisation can include observation of some of these CQAs through tests, such as charge variant profiling and aggregate analysis.

Recently, there has been a substantial focus on quality by design (QbD), with a joint pilot study by the EMA and FDA concluding that both agencies are well-aligned regarding the implementation of QbD concepts from ICH Q8, 9 and 10. They also stated that both agencies are “currently exploring potential joint activities with specific focus on continuous manufacturing, additional emerging technologies, and expedited/accelerated assessments”. The attention on utilising powerful detection techniques such as high-resolution mass spectrometry (MS) is growing within the chemistry, manufacturing and control stages through to quality control (QC) and lot release stages due to the increased levels of accuracy and information obtainable.

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Simon Cubbon is a Pharma and Biopharma Vertical Marketing Manager at Thermo Fisher Scientific. He has worked within the analytical instruments industry for over 10 years, holding a variety of positions, from applications scientist through to informatics product management. Simon studied for his PhD at the University of York, UK, where he investigated using LC-MS to study the metabolic profile of long bone fractures.
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