Case Study

Case Study: From Variability To Validation – GMP Bioassay Success Through Partnership

Source: Solvias
clinical-cmo-partnership-GettyImages-1371822410

When a biopharma company needed GMP validation for an established bioassay, they faced hurdles:

  • Undocumented method adaptations leading to executional variability
  • Acceptance criteria not reflecting natural assay variability
  • Sample viscosity differences affecting pipetting and results consistency

They turned to Solvias. Together, we transformed their assay into a GMP-validated, reliable platform, slashing failure rates from ~25% to <1%.

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