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9. Primary to Secondary Pharmaceutical Processing

Liz Meehan

 

Pharmaceutical Technology and Development at AstraZeneca

Leader, Primary to Secondary Pharmaceutical Processing Workstream (App B)

 

A more flexible and agile Medicines supply chain will be enabled by wider implementation of advanced (continuous or additive) manufacturing processes for both drug substance and drug product. Future supply chains need to embrace emerging technologies where advances in stratified and personalised medicines require a more diverse set of products with lower volumes that serve ever smaller patient populations.

 

The emergence of new technologies is changing the manufacturing landscape and alternative production processes and scales of manufacture are now accessible. This requires either the development and commercialisation of new equipment not yet available to the pharmaceutical sector or the ability to deploy nascent manufacturing technology platforms in an increased number of pharmaceutical products.

Through a multidisciplinary approach embracing diverse skills such as material science, formulation science, process engineering, process monitoring and control and process modelling, App B has demonstrated how implementation of advanced manufacturing technologies can be accelerated.

 

User trials and case studies for some strategic technology platforms including continuous drug substance isolation, continuous direct compression, hot melt extrusion and 3D printing, have exemplified how these advanced manufacturing processes can be deployed to meet the challenges of future clinical and commercial supply chains. The team have focussed on how to address scientific and technical challenges for technology implementation as well as considering the quality, regulatory and training needs that will be required to fully embed a step change in the UK pharmaceutical industry.”