PRODUCTS
CLADE™ QA Scan – A method for multi-attribute analytics of biologics formulations
Get end-point results on selected quality attributes of your API and excipients from a single FTIR measurement.
CLADE™ QA Scan is a data analytics method designed for biopharma teams who need fast, standardised reports on multiple quality attributes in their formulations. It transforms mid-IR FTIR spectra from the CLADE™ MIRA Analyzer into end point results, enabling confident decisions across formulation, analytical, and process development workflows.
Getting full formulation insight should take less effort
In biologics development, quality checks on a single formulation can trigger a long list of analytical methods to measure API concentration, secondary structure, checks on surfactants and other excipients, etc. This is time and resource intensive, and generates fragmented data.
Formulation data from FTIR spectra, in a few clicks
The CLADE™ QA Scan algorithm uses chemometric modelling and spectral database SpecHub™ to process FTIR spectra and report formulation quality attributes. It removes the need for manual spectral subtraction or complex model development for each individual attribute.
2. Tailor it to your analytical needs
- Easily create methods for defined biologics formulations
- Supports multi-attribute results including protein concentration, protein secondary structure, protein identity (based on spectra similarity), concentration of individual excipients, surfactants concentration (e.g., polysorbate 20/80), and pH value
How does CLADE™ QA Scan work
Creating and running a QA Scan method is fast and easy as it uses a guided workflow.
Create a new QA Scan method in Sphere
Step 1: Select quality attributes to analyse
Step 2: Define formulation components and the buffer
Step 3: Select data for calibration
Step 4: Input reference values for formulation components
Run your QA Scan method
Step 1: Select data to analyse
Step 2: Open your method
Step 3: Run the method
Step 4: Get reported values for the selected quality attributes
Learn how to use QA Scan
What does a QA Scan report look like
The QA Scan reports the end point values on selected quality attributes in formulation samples.
The output is a consolidated table, presenting reported / predicted values for the formulation components and attributes tested.
Sample QA Scan report
In the example below, you can see the quantification of 4 batches across 5 formulation components: an API (a monoclonal antibody, mAb) and 4 excipients.
| 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 |
CLADE™ QA Scan application space
Workflows:
QC
- Analytical development
- Formulation development
- Process development
- Downstream processing
Use cases:
- Formulation analytics
- API concentration
- Excipient testing
- Surfactant testing
- Secondary mAbs structure
- Protein stability
Applications:
UF/DF monitoring
- Release testing
- Buffer quality control
- Upstream processing
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.