Case Studies - Pharma

Addressing Loss of Yield and Increased Impurity Levels in Clinical Manufacture

Product manufacture in AZ’s Large Scale Lab encountered a significant negative trend in yield and increased impurity for a particular product. A three-hour Britest session identified 14 potential corrective actions covering chemistry, engineering and analysis. By systematic testing, the root cause (oxygen ingress) was identified. By improving vessel purging AZ were able to reduce impurity to 2% and increase the yield from 50% to 70%. Successful manufacture corresponded to $250K of cost deferred.

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Mapping the Manufacturing Value Stream to Spot Improvement Opportunities

When the technical team responsible for a market-leading medicine within a high-profile global, science-led biopharmaceutical company wanted to establish where process improvement opportunities existed for the product line, they turned to a Britest study to summarise process inputs, outputs and key information. The study allowed the manufacturing value stream to be seen end-to-end in great detail for the first time ever, highlighting value gaps and the scale and location of improvement opportunities, and catalysed both "quick-win" actions, and a plan to deliver the pipeline of improvement projects identified.

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- OPERATIONAL EXCELLENCE- WHOLE PROCESS UNDERSTANDINGPharmaProcess ImprovementTOOL - Process Information Summary Map

Overcoming Analytical Sample Preparation Issues to Improve Method Reliability

Analytical scientists at AstraZeneca were able to rapidly and effectively identify and eliminate subtle procedural variations in a test method being used to make product quality decisions with significant cost implications for any batch wrongly rejected. Britest tools were used to visualise the sample preparation regime in detail, breaking it down to identify potential sources of variation, and prioritise these for further investigation in a factorial experimental design. Re-wording the test method restored the method to control, saving $10-50k per out of specification result prevented.

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- PROBLEM SOLVINGAnalytical ChemistryPharmaTOOL - Rich Pictures

Use of Britest to aid Communication and Problem Solving

Read how the use of the Britest tools and approach encouraged chemists and engineers in a large manufacturing organisation to address a problem in pressure filtration which had been dragging on for three years - saving the business £500K a year. 

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Rapid optimisation of a new process in Pharmaceutical API manufacture

Read how Britest successfully provided the structured approach needed by a process development centre within a large multi-national pharmaceutical business to optimise a new process in a very short time period.

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Problem Solving through Process Understanding - Particle Coating for Controlled Release

Read how a Britest problem solving study rapidly enabled a major pharmaceutical manufacturer to get a controlled release drug capsules product back to target release profile after transferring the process to new manufacturing equipment.

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- PROBLEM SOLVINGPharmaTOOL - Process Definition DiagramTOOL - Rich Pictures

Britest in Drug Product Development

A large pharmaceutical manufacturing Britest member had identified processing issues associated with a micronisation step during late stage development with several new drug candidates intended for inhalation. A multi-disciplinary, cross-site team was put together which used Britest tools to identify key material attributes, equipment and process parameters impacting upon the micronisation unit operation. With the root causes identified the team was able to define a generic workflow and guidance for successful micronisation in the future.

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- PROBLEM SOLVINGPharmaTOOL - Driving Force AnalysisTOOL - Rich Pictures