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'.
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.
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.
This case study describes how a Britest study enabled an internal cross-functional team at Robinson Brothers Limited to rapidly identify and implement process changes designed to improve efficiency and up time, making it possible to support extra sales of ~£1M p.a.
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.