APPLICATIONS
Faster raw material control and sample QC
Assess multiple raw material quality attributes in one-go to identify deviations from expected QC standards
Raw material variability is a critical risk in biopharmaceutical manufacturing because it can affect formulation performance, product stability and batch consistency.
CLADE™ analytical tools support rapid screening of starting materials by detecting FTIR spectral deviations from expected quality standards in a single 4-minute measurement on MIRA Analyzer.
Raw material quality control, done faster
CLADE™ analytical tools combine mid-infrared FTIR spectroscopy with chemometric data analytics to generate a molecular fingerprint of aqueous samples quickly and reproducibly.
Detect deviations from expected quality standards early
CLADE™ technologies acquire and analyse a molecular fingerprint of each sample. The fingerprint is an FTIR spectrum that reflects infrared-active substances in the sample. Comparing that spectrum with a reference or model can highlight deviations from expected composition.
Use rapid multi-attribute measurement with CLADE™ technologies to support raw material release decisions, supplier qualification and deviation investigations.
Use case: Compare Polysorbate 80 quality across suppliers
In this example, samples of the surfactant polysorbate 80 (PS80) from five suppliers were characterised with the CLADE™ MIRA Analyzer. The spectra showed supplier-specific differences in under four minutes (Figure 1).
Figure 1. Overlay of normalised FTIR spectra from five supplier PS80 samples characterised with the CLADE™ MIRA Analyzer, showing supplier-specific spectral differences.
This example shows how FTIR spectroscopy can reveal raw-material differences that may support supplier qualification, deviation investigation and formulation optimisation.
Benefit from CLADE™ technologies for rapid raw material screening to support formulation performance, batch-to-batch consistency and product integrity.
Use case: Detect sorbitol contaminants at very low concentrations
Sorbitol, which is used in some biopharma formulations, may be vulnerable to contamination or adulteration with ethylene glycol (EG) and diethylene glycol (DEG).
The CLADE™ MIRA Analyzer, together with multivariate data analysis in Sphere, gives analytical teams a rapid screening approach for sorbitol samples and EG/DEG-related spectral differences, even when present at low concentrations.
In this example, 10 sorbitol and EG/DEG mixtures simulated adulterated sorbitol samples, with EG/DEG concentrations from 0 to 0.15%.
Figure 2. PCA analysis of normalised spectra from sorbitol, EG and DEG mixtures, showing separation of the sorbitol-only sample (DoE_01), samples containing 0.05% EG/DEG (DoE_08, DoE_09, DoE_10), and samples containing 0.1-0.15% EG/DEG.
Multivariate analysis separated the sorbitol-only sample from samples containing 0.05-0.15% EG/DEG, even where separation was not obvious by visual inspection of overlaid spectra.
Read the application note for the experimental design, analytical model and full results.
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