APPLICATIONS
Faster release testing workflows for biologics
Detect batch-to-batch variability faster and support QC decisions for biologics products
Batch-to-batch variability is a major risk in biopharmaceutical manufacturing. Undetected differences in batch composition can lead to unexpected performance issues, regulatory delays, and costly production failures.
CLADE™ analytical tools can quantify selected quality attributes in each batch and detect deviations from reference batches, helping QC teams investigate batch variability and support release decisions.
A single method for multiple quality attributes in release testing
CLADE™ advanced mid-IR spectroscopy and chemometric data processing deliver rapid end-point data to compare sample composition and detect batch-to-batch variability.
Less time and operational effort for batch comparability
Traditional release testing workflows often rely on multiple single-attribute methods. These methods are robust and sensitive, but they can be time-consuming and resource-intensive when multiple formulation attributes need to be checked.
With the CLADE™ MIRA Analyzer, you can perform FTIR measurements of aqueous samples. Combined with CLADE™ Sphere and QA Scan data analytics tools, the workflow can produce quantitative data on selected batch quality attributes within minutes.
Use rapid multi-attribute analysis to support QC workflows, batch comparability assessments and deviation investigations.
Detect batch inconsistencies in drug products
In this example, a formulation including excipients and an API, a monoclonal antibody (mAb), was assessed across 4 batches using CLADE™ MIRA Analyzer.
The overlaid spectral data show a deviation in Batch 3, with lower Amide I/II absorbance (1450-1700 cm⁻¹) than the other batches (Figure 1), consistent with a lower protein/API signal in this example.
Figure 1. Differences across four batches of a mAb formulation were detected from CLADE™ MIRA Analyzer’s spectral data.
The spectral data can then be analysed with QA Scan to generate quantitative results for decision-making. This can help identify formulation deviations earlier and support batch investigations.
Quantify mAb batch deviations with CLADE™ QA Scan
FTIR spectra from drug product batches acquired with the CLADE™ MIRA Analyzer can be evaluated with CLADE™ QA Scan, which applies chemometric modelling to quantify selected quality attributes.
The QA Scan output table provides end-point values for selected quality attributes, including excipients and API. In this example, the excipients were within target, but Batch 3 was reported below the target API concentration of 150 mg/mL (Figure 2).
| Component | Batch 1 | Batch 2 | Batch 3 | Batch 4 |
|---|---|---|---|---|
| Citrate Buffer | 4.93 mg/ml | 4.9 mg/ml | 4.91 mg/ml | 4.87 mg/ml |
| Mannitol | 4.89 mg/ml | 4.95 mg/ml | 4.89 mg/ml | 4.77 mg/ml |
| NaCl | 8.78 mg/ml | 8.71 mg/ml | 8.88 mg/ml | 8.68 mg/ml |
| PS80 | 0.5 mg/ml | 0.5 mg/ml | 0.48 mg/ml | 0.51 mg/ml |
| mAb | 150 mg/ml | 148.5 mg/ml | 130 mg/ml | 148 mg/ml |
Figure 2. CLADE™ QA Scan output table showing end-point values for selected quality attributes, including excipients and API concentration.
Explore more applications for more efficient bioanalytical workflows
Connect with CLADE
Inquire about a product
Request a quote, send us a sample for analysis or other inquiries.
Talk to an
expert
Schedule a call with a CLADE expert and discuss your needs.
Follow CLADE on LinkedIn
Join this community to keep updated on latest developments.