Expedited, unmatched, cGMP ADC DS & DP release testing
Drawing on decades of experience in testing and releasing drug substances and products, Solvias specializes in antibody-drug conjugates (ADCs) and other innovative therapies. The team is adept at identifying critical quality attributes (CQAs) and crafting testing strategy for effective product release.
Unique combination of benefits
- Robust, efficient testing in accordance with ICH Q2A/Q2B can lower release testing costs.
- Rapid turnaround, helping eliminate supply chain bottlenecks.
- Wide range of cutting-edge, cGMP-compliant analytical technologies and methods.
- Customized service design to deliver the phase-appropriate results you need
- Deep regulatory know-how to help you identify the right, minimum combination of tests
Comprehensive service solutions
We offer a complete portfolio of drug substance (DS) and drug product (DP) testing and release services for:
- Sequence: PepMap (UV/MS)
- Charge: Capillary isoelectric focusing (cIEF), Capillary zone electrophoresis (CZE), Ion-exchange (IEX)
- Size: Size-exclusion (SEC), Capillary electrophoresis sodium dodecyl sulfate (CE-SDS)
- Binding enzyme-linked immunosorbent assay (ELISA)
- Cell-based bioassay
- Surface plasmon resonance (SPR)
- Deamidation/Oxidation: qPepMap (UV/MS)
- Charge: Capillary isoelectric focusing (cIEF), Capillary zone electrophoresis (CZE), Ion-exchange (IEX)
- Size: Size-exclusion (SEC), Capillary electrophoresis sodium dodecyl sulfate (CE-SDS)
- Toxin: Free toxin RPC
- Hydrophobic interaction chromatography (HIC)
- Liquid chromatography–mass spectrometry (LC–MS)
- pH potentiometry
- Conductivity
- Degree of coloration
- Turbidity
- Osmolality
- Sub-visible particles (Light obscuration, Micro-flow imaging)
- Visible particles
- Bacterial Endotoxins
- Bioburden
- Sterility
