Analytical Development

Development, Optimization and Validation of Analytical Methods

Our services span from the feasibility, method development and optimization phases of new methods of analysis, to their qualification/ validation for Quality Control of raw materials, In-process control samples, drug substance and final product under GMP.

• Chemical, biological, molecular biology and cell based assays are qualified according to ICH;
• Post development and analytical method transfer for QC.

Support to Pharmaceutical and Biopharmaceutical Development

• Protein identification by Mass Spectrometry including intact mass, peptide mass fingerprinting, confirmation of glycosylation pattern, identification of host cell proteins;
• Evaluation of chemical, biological and viral contamination;
• Analysis of cell and virus banks.

Analytical Services (GMP)

Quality control – Authorized Manufacturing Operations

We work on quality control and batch release of human, veterinary and experimental drugs with a strong focus on biopharmaceuticals.

• Batch certification
  • Non-sterile Products
  • Biological Medicinal Products (immunological, cell therapy, gene therapy and biotechnology products)
• Quality Control Testing
  • Microbiological, non-sterility
  • Chemical/Physical
  • Biological

Analytical Assays and Techniques

Molecular Identity and Structural Integrity

• Mass spectrometry (molecular mass, peptide mass fingerprinting)
• Post Translational Modifications (e.g., glycosylation and phosphorylation)
• Glycan profile
• Isoelectric point
• SDS-PAGE
• qPCR
• Restriction enzyme analysis
• Immunoassays (e.g., Western Blot, ELISA)
• Aggregation and refolding (SEC and RP chromatography)
• Genomic integrity

Potency and Titers

• Molecular Biology
• Functional and Potency Titer for Cell based assays: TCID50, plaque assay, reporter gene assays, cell viability and proliferation, apoptosis and cell death, antibody dependent cell mediated citoxicity (ADCC), signaling and secretion.
• Physical Titer (Spectrophotometry, qPCR)
• Immunoassays including Western Blot, ELISA
• Total protein quantification

Impurity Profiling

• Adventitious contaminating viruses
• Process related impurities (Residual/Host Cell protein and DNA; Benzonase, Triton, BSA, Polysorbate…)

Chemical

• Compendial methods – pH, appearance, extractable volume, identity
• Chromatography
• Capillary electrophoresis
• Spectrophotometry

Analytical Services Equipment

The GMP Analytical Services facilities involve laboratories for mass spectrometry, chromatography, microbiology and cell-based assays.

The laboratories are installed in newly refurbished facilities equipped with q-PCR, GC (FID), GC-MS, Capillary electrophoresis (PDA and LIF), HPLC and UPLC systems (Fluorescence, UV/vis., PDA, RI) as well as spectrophotometers (FT-IR UV/Vis., Fluorescence) and image processors (Chemidoc).

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Recombinant Proteins

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Mass Spectrometry

Structural Biology and Molecular Interactions