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%
Mapping the Manufacturing Value Stream to Spot Improvement Opportunities
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
Overcoming Analytical Sample Preparation Issues to Improve Method Reliability
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
Use of Britest to aid Communication and Problem Solving
Using the Britest tools and approach provided a way for chemists and engineers in a large manufacturing organisation to work effectively together in order to address a problem in pressure filtration which had been dragging on for three years - saving the business £500K a year. Download 'Aiding Communication and Problem Solving' case study Read how the use of the Britest tools and
Rapid optimisation of a new process in Pharmaceutical API manufacture
Pharma businesses constantly need to improve processing routes for Active Pharmaceutical Ingredients (APIs) to achieve competitive gains - increased yields, reduced costs, increased throughput and reduced process footprint. At one of our major Pharma sector manufacturing member companies, the team implementing a new telescoped API process developed using a novel and only partially understood
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. Download 'Problem Solving through Process Understanding - Controlled Release' case study Read how a Britest problem solving study rapidly enabled a
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