Characterize Structure, Purity, Identification, Concentration, and Additional Characterization Techniques in Biologics and ATMPs
Comprehensive structural analysis and characterization
Ensure the safety, efficacy, and regulatory success of your biologics and advanced therapies with our CMC biophysical services. We deliver precise, high-resolution characterization to confirm identity, purity, and other critical quality attributes, detecting impurities and structural changes before they become risks.
Identity testing to confirm critical quality attributes
In accordance with regulatory requirements, we offer a broad range of identification assays to verify the structural and functional integrity of your drug product. The necessary and appropriate technologies can be applied as needed to ensure these are met. The techniques range from PCR to HPLC to HRMS, among others.
- Primary structure (intact mass/peptide mapping)
- Subunit/size confirmation
- Charge variant profiling
- Glycosylation/post-translational modifications (PTMs)
- Binding (ELISA, SPR)
Biophysical characterization and concentration for product consistency and safety
To ensure the consistency and stability of your biologic or cell and gene therapy product, we provide a suite of biophysical characterization assays such as:
- Visual appearance assessments
- Container closure integrity testing
- Sub-visible particle analysis
- Particulate matter testing
- Compendial testing (e.g., wet chemistry for pH, osmolality)
Support for diverse therapeutic modalities
Our biophysical methods are optimized to handle complex modalities, such as:
- Monoclonal antibodies (mAbs)
- Bi/Tri-specific antibodies
- Antibody-drug conjugates (ADCs)
- Proteins and peptides
- Fusion proteins
- Vaccines
- Gene therapies
- Cell therapies
Purity assessment to detect impurities and variants
Comprehensive purity testing is essential for ensuring product quality and patient safety. Our analytical capabilities are designed to detect and quantify a range of process-related impurities, including:
- Host cell proteins (HCP)
- Host cell DNA (residual DNA)
- Process/product-related impurities
- Post-translational modifications (PTMs)
- Isoform analysis
Advanced analytical platforms for biologics
We utilize biophysical methods to build a complete picture of your therapeutic. Our GMP-compliant platforms are phase-appropriate and ready for regulatory submission.
- HPLC/UPLC
- Real-time MALS
- DLS
- Biacore (SPR)
- CE/cIEF
- LC/HRMS
- HIAC
- SoloVPE®
Integrated CMC bioassay services through commercial release
Functional, binding, and cell-based potency assays tailored to your therapeutic with direct access to the scientists managing your project, providing regulatory confidence, product reliability, and patient safety.