Protein Method Development and Validation

Solvias has the expertise and experience to perform complete analytical development programs. We satisfy our clients with a combination of our know-how and the broad laboratory infrastructure of a big-pharma environment.

At the early stage of drug development, clients need to move forward rapidly and cost effectively. This is where the experience of Solvias is invaluable. Our generic methods will normally be directly applicable to your protein. Our ability to select promising analytical methods – and carry out development, validation and transfers – within the constraints of GMP and registration deadlines, gives our customers a competitive advantage.

For complex projects, workflow management is vital in achieving a successful outcome. A dedicated team of professional project managers ensure efficient coordination and communication with all parties.

Examples of QC methods validated according to ICH Guidelines:

  • RP-HPLC, SEC, IEC
  • HPLC-MS/MS, GC-MS
  • CE: CZE, CGE, IEF
  • SDS-PAGE
  • Spectroscopic methods
  • ELISA
  • Residual DNA
  • Rodent parvovirus
  • Bioburden and endotoxin

Solvias has experience in method transfer to third-parties.