Protein Method Development and Validation Services
At Solvias, we perform complete analytical development programs across our multidisciplinary laboratory infrastructure at our Kaiseraugst site. We understand that you need to progress rapidly and cost effectively at the early stage of drug development. Here, our extensive experience saves you time and we can normally apply generic methods to your protein. You can trust us to select promising analytical methods – and carry out development, validation and transfers – within the constraints of GMP and registration deadlines. Using our generic methods means that you stay one step ahead of the competition.
For complex projects, workflow management is vital in achieving a successful outcome. We give you a dedicated team of professional project managers to ensure efficient coordination and communication between all parties.
QC methods validated according to ICH (Q2A, Q2B) guidelines include:
- HPLC methods: IEX, SEC, RP, HIC, HILIC, NP, HPAEC, IC, Affinity Chromatography
- HPLC detection: UV, FL, RI, ELSD, CAD, MALLS, MS
- CE methods: CGE, CIEF, CZE, iCE280, Bioanalyzer
- Spectroscopic methods: CD, UV, FL, IR, NMR, DLS, MALLS, DSC
- Mass spectrometric methods: MALDI TOF-TOF, LC-MS(n) (Orbitrap, Triple Quad, Ion Trap)
- Others: Immunological methods, ELISA, Western blotting, Residual DNA (threshold analysis, qPCR), Rodent parvoviruses, Bioburden, Endotoxin, Sterility, Potency assays