iBET’s Analytical Services Unit (ASU) targets the chemical, pharmaceutical and biopharmaceutical industries
Our Analytical Services Unit (ASU) offers GMP (Good Manufacturing Practices) certified Services for chemical and biological products for human and veterinary use.
The GMP certification was granted to the Analytical Services Unit (ASU) in 2013 under the Art. 40 of Directive 2001/83/EC and Art. 13 of Directive 2001/20/EC and it has been renewed ever since (latest renewal in 2021).
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
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
- 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
• Adventitious contaminating viruses
• Process related impurities (Residual/Host Cell protein and DNA; Benzonase, Triton, BSA, Polysorbate…)
• Compendial methods – pH, appearance, extractable volume, identity
• Capillary electrophoresis
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).