Industry-leading risk assessment data to enable effective clinical strategies.
Our developability assessment expertise helps identify the physical and chemical properties of drug candidates, such as aggregation, post-translational modifications, stability, and solubility, that can negatively impact the safety, efficacy, manufacturability and ultimately the success of clinical candidates. Our approach combines in silico modeling, stress, stability and concentration tests. Our clients can enter the preclinical space with the knowledge of process parameters to mitigate liabilities that cannot be engineered out of the molecule, to help avoid costly and time-consuming formulation development efforts, and clinical failures with appropriate control strategies.
We provide our clients the tools and understanding to achieve successful protein characterization and process development in a phase-appropriate manner. We offer a broad range of analytical testing capabilities including protein mass, protein titer, protein stability as well as protein integrity and structure determination. Aragen offers binding affinity assays, enzyme activity assays, cell-based assays and a host of in vivo efficacy testing assays.
We offer:
Protein
Activity
Binding affinity (FortéBio Octet® RED96 System, GE Biacore™ 3000)
Enzyme activity
Cell-based assays
In vivo testing
Protein Titer/Concentration
Protein A HPLC
ELISA
A280
Protein Integrity & Structure
Size variants by SEC-HPLC
Size variants by SEC-MALS
Size variants by CE-SDS (reduced and non-reduced)
Hydrophobic variants by RP-HPLC/UPLC or HIC
Protein purity by SDS-PAGE
N-glycan analysis by HILIC-FLD
N-glycan analysis by CE
Sialic acid content by DMB RP
Free thiol content by SEC-FLD
Charge variants by cIEF
Western Blot
HCP titer by ELISA
Residual Protein A, Protein G, Protein L by ELISA or Octet
Endotoxin levels by LAL
Protein Stability (Unchained Labs: Uncle)
Tm and Tagg
△G
Isothermal stability
Thermal recovery
Sizing and polydispersity
Sizing with thermal ramp
B22 and kD
Viscosity
Protein mass (Agilent HPLC- CHIP/QTOF)
Accurate mass: proteins, protein-drug conjugates
Peptide and Glycan mapping
Determination of post-translation modifications either in known or unknown samples
