Detect Batch Variability in Biopharmaceutical Release Testing of mAb formulation
Batch-to-batch variability is a major risk in biopharmaceutical manufacturing. Undetected differences in formulation composition can lead to unexpected performance issues, regulatory delays, and costly batch failures. Traditional release testing methods often lack the speed and sensitivity needed to catch subtle variations before they become a problem.
With advanced FTIR analysis and precise quantification, we help ensure every batch meets strict quality standards. Our approach detects even the smallest deviations in formulation, enabling manufacturers to avoid inconsistencies, maintain compliance, and ensure product reliability.
The CLADE™ QA Scan enables accurate quantification of all components within a drug product. The data below show a monoclonal antibody formulation across different batches. While all excipients are well formulated, Batch 3 falls significantly below the target API concentration (150 mg/mL). CLADE™ QA Scan precisely quantifies it at 130 mg/mL, and this deviation is clearly reflected in the FTIR spectra—with significantly decreased Amide I and Amide II bands (1500 - 1750 cm⁻¹). Go into the spectra below and browse the difference between the batches.
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| 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 |