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Workstream (App) “B” – Primary to Secondary

Workstream Leader                                             

Liz Meehan, AstraZeneca

Work Stream Objectives  

Generate understanding around the impact that API physical properties have on drug product process robustness and product quality.

Develop API filtration/drying strategies that reduce processing time/cost and minimise negative impact on API physical properties

Demonstrate flexible and agile drug product manufacturing capabilities which implement continuous processing operations, where product is monitored during processing and the process is adjusted based upon input API properties and in-process measurements

Key strand objectives           

STRAND 1 : to design equipment for continuous filtration of drug substance with the ability to reduce processing time, improve linkage to continuous drying and to deliver enhanced control over particle properties rendering the material more compatible with downstream drug product processes. Demonstrate benefits via exemplary case studies.

STRAND 2 : to define a design space for the implementation of continuous blending and direct compression in terms of critical material attributes and critical process parameters. Demonstrate potential for the wider application of continuous blending and direct compression and the subsequent benefits for clinical and commercial supply chain

STRAND 3 to demonstrate the ability of hot melt extrusion technology to produce oral solid dosage forms in one continuous process. Demonstrate potential for the wider application of hot melt extrusion and the subsequent benefits for clinical and commercial supply chain.

Applicable to all strands : Develop new tools and training packages to support advanced manufacturing technologies.

Technical updates

CLick here to see the technical updates for each strand in this workstream

Partners

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PSE

Alconbury Weston