Articles & Case Studies
Minimize risk with early-stage analytical method development and validation
The successful launch of a new drug application hinges on your analytical method development. It is vital to establish a clear understanding of method design and robustness early in the process to minimize risk. Solvias offers comprehensive method development services, guiding you from early-stage to approval and commercialization, balancing cost-efficiency and quality.
Unique combination of benefits
- Expert-led analytical method development and validation
- Faster development using platform methods spanning early characterization and development to fully validated late- to commercial-stage QC panels
- Flexible options for client established methods
- Focus on quality, speed, and risk mitigation
Comprehensive service solutions
The breadth of our analytical method development portfolio, expert team, and experience equip Solvias to provide a comprehensive CMC program for small molecules, biologics, and cell and gene therapies.
Validated QC methods
Successful molecule dependent methods have been developed for the following techniques:
HPLC (IEX, SEC, RP, HIC, HILIC, NP, HPAEC, IC, affinity with UV, FL, RI, ELSD, MALLS and MS detection
CGE (UV, LIF), CGE-SDS (UV, FL, LIF), cIEF (UV, FL, MS), CZE (UV, LIF, MS)
CD, SoloVPE UV, FL, FT-IR, Raman, SEM-EDX NMR, DLS, MALLS, AUC
Osmolarity, density, viscosity (rolling ball, capillary, rheometer) nDSC, visible and subvisible particles (membrane microscopy, light obscuration, flow imaging)
Particle size determination (PSD), microscopy (optical, SEM, TEM), specific surface area, porosity, bulk and tapped density, X-ray diffraction (XRD, XRPD), differential scanning calorimetry (DSC), isothermal calorimetry, solution calorimetry, thermogravimetric analysis (TGA, TG-FTIR), dynamic/gravimetric vapor sorption (DVS/GVS), microscopy (optical), and water activity measurements. All methods are performed under GMP conditions to ensure quality and compliance.
APSD (NGI), DDU, droplet size distribution, spray pattern & plume geometry
Intrinsic, extrinsic, UV and HPLC readout, friability
LC-MS (Orbitrap, qTOF, Triple Quad), GC-MS, (Orbitrap, Triple Quad, Single Quad) CE-MS (cIEF-qTOF-MS, CZE-qTOF-MS), Hydrogen-Deuterium-Exchange Mass spectrometry HDX-MS (LEAP-PAL – Orbitrap-MS)
ICP-MS, ICP-OES, AAS, XRF
Cell-based bioassay, ELISA, western blotting, residual DNA (threshold analysis, qPCR), rodent parvoviruses, surface plasmon resonance, RNA and DNA sequencing
Bioburden, endotoxin, sterility, viral safety, cell biology methods and potency assays
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