Biologics Developability Assessment and Analytical Testing
Assessment data generated to support candidate evaluation and clinical development planning.
Aragen Life Sciences assesses whether biologic drug candidates can be developed and manufactured, and provides the analytical tests to characterize them.
Developability assessment looks for properties such as aggregation, post-translational modifications, stability and solubility. These can affect safety, efficacy and manufacturability. We combine in silico modeling with stress, stability and concentration tests.
Early results help teams plan process controls before preclinical studies and avoid costly formulation work.
Analytical testing at a glance
| Test area | What it tells you | Methods |
|---|---|---|
| Protein activity | Whether the protein does what it should | Binding affinity (Octet RED96, Biacore 3000), enzyme activity, cell-based assays, in vivo testing |
| Titer and concentration | How much protein is present | Protein A HPLC, ELISA, A280 |
| Integrity and structure | Size, charge and hydrophobic variants, purity, glycans and impurities | SEC-HPLC, SEC-MALS, CE-SDS, RP-HPLC/UPLC, HIC, cIEF, SDS-PAGE, HILIC-FLD and CE glycan analysis, Western blot, HCP ELISA, endotoxin (LAL) |
| Stability | How the protein resists heat and aggregation | Tm and Tagg, ΔG, isothermal stability, thermal recovery, sizing and polydispersity, B22 and kD, viscosity (Unchained Labs Uncle) |
| Mass | Accurate mass, modifications and mapping | Accurate mass of proteins and protein-drug conjugates, peptide and glycan mapping, post-translational modification analysis, standard certificates of analysis (Agilent HPLC-CHIP/QTOF) |
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
- Standard COAs
Frequently Asked Questions (FAQs)
Related Links
Our Journey
More than 25 years of transforming ideas into solutions.
Working at Aragen
At Aragen, we take pride in what we do, enjoy working as a team, learn from every experience and celebrate success together. ‘We Invest. We Learn. We Grow.’
