PRECISION ANALYTICS
Data-Driven
ICH Validation
High Resolution
Data-Driven
Decision Making
We employ a "quality by design" (QbD) approach, utilizing state-of-the-art instrumentation to ensure the identity, purity, potency and safety of every product. Our analytical methods are developed and validated to meet global ICH regulatory standards.
STATUS: ACQUIRING
METHOD: RP-HPLC
RT: 12.45 min
Comprehensive Characterization
Our analytical platform covers the entire spectrum of product attributes ensuring a complete understanding of the molecule.
Physico-Chemical
- Intact Mass Analysis (LC-MS)
- Peptide Mapping
- Glycan Profiling
- Charge Variant Analysis (CEX)
Purity & Impurities
- Size Exclusion (SEC-HPLC)
- Host Cell Protein (HCP) ELISA
- Residual DNA (qPCR)
- Endotoxin Testing
Biological Activity
- Cell-Based Potency Assays
- Ligand Binding Assays (ELISA/SPR)
- ADCC / CDC Activity
- Signal Transduction
Biophysical
- Circular Dichroism (CD)
- DSC / DSF
- Dynamic Light Scattering (DLS)
- Sub-visible Particles (MFI)
Stability
- Real-time Stability
- Accelerated Stress Testing
- Photostability
- Freeze-Thaw Cycling
Stress Testing
- Oxidation
- Deamidation
- pH Excursion
- Agitation