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Rapid, high-quality, cGMP-compliant DS and DP release testing
Solvias has decades of experience performing drug substance and drug product testing and release for small molecules, biologics, and cell and gene therapies. We can help establish your critical quality attributes (CQAs) and devise the right combinations of tests for 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:
Solvias has extensive experience assessing biopharmaceutical drug substances (DS) and drug products (DP) using cGMP-qualified methods and technologies. We provide a comprehensive solution for drug substance (DS) and drug product (DP) batch release testing for monoclonal antibodies (mAb), bispecific antibodies, ADC’s and other recombinant proteins.
We can also help address requests from authorities during IND/BLA, using an orthogonal technology to confirm analytical data or to provide additional requested data.
Solvias can provide release and stability testing for viral vectors. Our capabilities are comprehensive, from biophysical characterization of capsid proteins, stability testing to potency and sterility testing.
Our genetic stability services monitor whether genetic drift has occurred during production of your biologics or viral vector. By genetically characterizing and comparing genetic consistency of your cell bank at two time points (e.g., MCB and EOP), our scientific experts can confirm whether your cells continue to share the same integration site(s) and transgene sequence, supporting confirmation to the regulatory authorities that your production is consistent.
Solvias provides full service analytical testing of drug substances (DS) and drug products (DP). Our capabilities include testing for identity, purity, impurities, potency, particulates, dissolution, bioavailability and potential interactions between drug substance and excipients. Mature and proven quality systems, together with our extensive analytical capabilities, help ensure full compliance for late stage development and commercial release.
We provide 10- to 15-day turnaround for full panel release, with integrated logistics, reporting, and a single COA.
Contact us for a complimentary consultation
