Physicochemical Characterization
To ensure the structural integrity and purity of your biologic, we offer the following services:
- Amino Acid Sequence Confirmation
- Peptide Mapping
- Intact & Reduced Mass & MW Deglycosylated Analysis
- Disulfide Linkage Confirmation
- Glycan Profiling (N-Linked Glycans, Sialic Acid, Site Specific Glycans)
- Post-translational Modifications (PTMs) by LC-MS (Oxidation, Deamidation, Pyroglutamate, N & C-Terminal Amino Acid confirmation)
Biophysical Characterization
Biophysical methods provide insights into the higher-order structure, stability, and behavior of your biologic in solution. Key services include:
- NGHC by CE-SDS (R)
- Higher-Order Structure (Circular Dichroism, Intrinsic Fluorescence, NMR)*
- Tm, Tonset, Tagg (DSF & SLS)
- Absolute Molar Mass & Size (MALS)*
- Hydrodynamic Radius (rH) by DLS
- PDI (Polydispersity index) by DLS
- kD (Diffusion interaction) by DLS
*Offered through an approved partner laboratory
Biological & Functional Testing
Understanding the biological activity and mechanism of action of your biologic is critical for demonstrating its therapeutic potential. Aragen offers extensive biological and functional testing to evaluate key properties like binding affinity, immune activation, and cytotoxicity. Our services include:
- FcγR (RIa, RIIa, RIIb, RIIIa & RIIIb) Binding Assays (SPR)
- FcRn Binding Assays (SPR)
- C1q Binding Assays (Cell-Based/ELISA/SPR)
- Complement Dependent Cytotoxicity (CDC) (Cell-Based/ELISA)
- Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) (Cell-Based/ELISA)
- Antibody-Dependent Cell-Mediated Phagocytosis (ADCP) (Cell-Based/ELISA)
Aragen’s team of experienced scientists and cutting-edge technologies ensure that your biologic product is thoroughly understood and ready for clinical trials or market release. With our in-depth Product Development services, you can have confidence in the quality, stability, and performance of your biologic from discovery through to commercialization.