Case Studies - Analytical Chemistry
Probing Deep Understanding of an LC-UV-MS Method for Characterising Oligonucleotides
When a multinational pharmaceutical manufacturer wanted to get to a deep understanding of a strategically important analytical method to inform improved training and method standardisation the Britest methodology was used to complement established methods of Analytical Risk Assessment. A tailored DuDES analysis identified opportunities to remove subjectivity from the method, leading to harmonisation across departments and external partners, identification of actions to improve training materials and the internal standardised method, and consequential benefits for in-country testing.
Efficient Analytical Validation Using Britest Visualisations As Protocols
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'.
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.