Analytical methods development, validation and GMP testing


Biologics and Biosimilar cGMP Release Testing:

  • Analytical methods development/qualification/validation
  • Impurity profiling
  • Analytical methods transfer from/to third parties
  • SOP’s of all analytical and control methods
  • Testing of intermediate products, drug substances and drug products
  • Reference standards preparation/qualification
  • Retention samples
  • Stability studies
  • cGMP batch  release testing.

Routine Release testing services include:

  • Pharmacopeia Monograph Tests
  • Protein purity assay and related proteins (HPLC and Isoelectric Focusing (IEF))
  • Peptide mapping
  • Product related impurities (SEC-HPLC, RP-HPLC)
  • PAGE-gel electrophoresis
  • Protein Concentration (A280, Bradford Assay, HPLC)
  • Residual Contaminant Assays
  • Bacterial Endotoxins
  • Host Cell Protein (HCPs) and DNA  Determination
  • Cell-based bioassays (cell proliferation, cytotoxicty, antiviral activity, receptor binding, etc.)
  • Physico-chemical properties including appearance, color, clarity/opalescence pH,particulates, turbidity, extractable volume, osmolality and moisture.

Testing activities of Quality Control:

  • Physicochemical methods (UV/vis, titration)
  • Microbiogical methods
  • Bacterial endotoxins
  • Residual process related impurities (host cells, DNA, Protein A, etc)
  • HPLC methods (UVIS/VIS and RI)
  • Pharmacopoeia compendial methods (pH, appearance,  solubility, loss on drying, sulphated ash)
  • Potency , cell based bio-assay.

V.A. Graiciuno 6, LT-02241,
Vilnius, Lithuania

Tel. +370 5 2629761,