General Quality Control Services

  • Pharmaceutical waters (PW, WFI, CS) testing
  • Critical systems (N2 distribution, compressed air distribution) testing
  • Environmental monitoring of classified areas (Class A, B, C and D)
  • Raw materials testing and release
  • Primary packaging materials testing and release
  • Secondary packaging materials testing and release
  • Active Pharmaceutical Ingredient (DS) analyses
  • In-Process Control (IPC)
  • Final product (DP) analyses
  • Complete development, qualification and validation of analytical methods to
    comply with international guidelines (ICH, EMA, FDA, etc.).
  • Transfer of analytical methods (<1224> USP)
  • Implementation and verification of Compendial methods (Eur. Ph., USP,
    international Pharmacopoeias)
  • Stability studies according to international guidelines (ICH, WHO, etc.)

Physicochemical and Biochemical laboratory

  • Potentiometric analyses (pH, conductivity)
  • Osmolality
  • Total organic carbon (TOC)
  • Water content (Karl-Fischer)
  • High performance liquid chromatography (HPLC): peptide mapping, SEC,
    impurities, excipients, purity, assay
  • Gas chromatography (GC)
  • UV-Vis spectrophotometry
  • UV-Vis microplate reader
  • Sub-visible particles
  • Total protein (Bradford, BCA, extinction coefficient, etc.)
  • Zeta potential
  • Micro and nano-particles size distribution
  • Electrophoresis SDS-PAGE
  • Western Blot
  • Isoelectric focusing (IEF)

Partners for other protein characterization testing

Liof Pharma can manage and coordinate the following analytical services:

  • Microbiological tests (bioburden, Gram, etc.)
  • Genetic stability (G-branding, CGH, etc.)
  • Flow cytometry
  • Mycoplasma
  • Impurity controls
  • PCR/qPCR
  • Cell viability (MTT)
  • Sterility (filtration, BacT-Alert)
  • Master and Working Cell Bank characterization (identity, purity, viability, genetic stability)
  • GC-MS
  • Atomic Spectroscopy
  • FTIR
  • Hydrolytic Resistance

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