APPLICATIONS
Faster buffer QC to reduce manufacturing bottlenecks
Detect pH and buffer component concentration variations quickly with CLADE™ technologies
Buffer quality is critical in biopharmaceutical production because it can affect protein stability, formulation performance and batch consistency.
CLADE™ analytical tools help detect buffer variations in pH and component concentrations early, supporting faster QC decisions before production.
Buffer QC, done faster
CLADE™ analytical tools combine mid-infrared FTIR spectroscopy with chemometric data analytics to generate buffer fingerprints in minutes, flag deviations from the target composition earlier and streamline pre-production buffer QC.
Detect deviations from buffer QC standards early
Routine buffer QC methods often test individual quality attributes separately and may miss composition-level deviations that matter for process performance.
Raw material variability, preparation errors and pH variation can contribute to protein aggregation, degradation or altered product performance, depending on the formulation.
CLADE™ analytical workflows use molecular fingerprinting to assess buffer composition, including excipients, pH-related spectral changes and salts. This supports rapid assessment of buffers against defined QC standards before production.
Use case: Validate your buffer preparations easily
In this example, 3 buffer formulations were measured with CLADE™ MIRA Analyzer and compared to the unknown Final Buffer preparation (Figure 1).
The tested buffers included 1) “citrate buffer”, 2) “citrate + mannitol” and 3) “citrate + mannitol + NaCl”, where buffer 3 represented the desired final buffer formulation.
The spectral overlay showed that the Final Buffer with unknown composition was most consistent with the intended final formulation (citrate + mannitol + NaCl).
Figure 1. The plot shows the overlay of normalised FTIR spectra of different buffer formulations characterised with CLADE™ MIRA Analyzer.
Note: although NaCl is infrared-inactive, CLADE™ data analytics tools can support indirect assessment of NaCl-related changes through their effect on the water signal in the buffer.
Quantify pH and NaCl concentration in your buffers
Spectral data can provide information on pH and NaCl contents in buffer formulations and detect potential shifts from quality standards.
In this example, we compared spectral fingerprints of the Final Buffer (desired formulation) to the same buffer with a) altered pH and b) lack of NaCl (Figure 2).
The results revealed quantifiable differences in spectra, allowing detection of pH and NaCl variations against the Final Buffer reference.
Figure 2. FTIR spectra showing pH-related and NaCl-related differences in a buffer formulation measured with the CLADE™ MIRA Analyzer.
CLADE™ Sphere data analytics platform can convert the spectra measured on the MIRA Analyzer into endpoint values for selected quality attributes, when a method and acceptance criteria are defined. Those outputs can support QC decision-making alongside the site’s established specifications and validation package.
Explore more applications for more efficient bioanalytical workflows
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