Protocols for Liquid Chromatography method validations under GMP often require complex dilution schemes with many opportunities for errors in execution. This necessitates inefficient extra checks, and duplication of work (further consuming valuable API). Presenting the dilution schemes visually using a Britest ‘Rich-PrISM’ has made the dilution schemes far easier for analysts to follow. The result is substantially reduced lead time and resource consumption, and all protocols executed 'right first time'.
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.
A large company in the pharmaceuticals sector has been able to transform the availability and hence use of existing information and existing work on the commonly used isolation technique of pressure filtration. Britest Rich Pictures and Cartoons provided an elegant format to portray and summarise current information and understanding, and by digitising these into a dedicated internal site, AstraZeneca were able to produce an easy to use guide to pressure filtration development.
A Britest methodology to support the optimisation of changeover/cleaning processes was used to help FUJIFILM Imaging Colorants address capacity constraints. Improvements to significantly time-consuming steps, and opportunities for improvements to existing CIP equipment were identified, along with a more ambitious opportunity to reduce the cleaning cycle time from 2-3 days to 12 hours through targeted use of a key cleaning solvent.
Stu Brew is Europe’s first student run microbrewery, helping students gain hands on experience at running a business, operating equipment and researching sustainability improvements for the brewing process. This case study describes how Britest tools have been used by Newcastle University to support operation of the microbrewery, and in particular to help train student operators to enhance process understanding.
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.
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.
This case study summarises how Infineum and Britest together developed an approach to effectively embed Britest in the organisation and the value gained.
This case study describes the elements of a Britest throughput improvement study carried out by a custom synthesis manufacturer to meet an identified customer need to increase process throughput by at least 50% within three years, which was successfully delivered by halving batch times.
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.