Case Studies - - PROBLEM SOLVING
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.
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.
Troubleshooting Reaction Issues in Additives Manufacture
An example of how a Britest study enabled one of the world's leading formulators, manufacturers and marketers of fuel and lubricant additives to gain a fundamental understanding of the influence of raw material composition and process conditions on the properties of a free-radically produced polymer which wasn't always hitting the mark. Having identified an issue in a critical raw material, Infineum were able to agree a new monomer specification with their supplier and save £350k a year.
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.
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.
Customer and Supplier Working Together as a Team
An illustration of how two Britest members in a supplier/customer relationship were able to use Britest as a framework for working together to solve a problem with a chemical intermediate product.
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.