Biochemistry

Instrumentation:

• Liquid Chromatography (HPLC, UPLC coupled by UV, PDA, TUV, RID, ELSD, Fluorimeter, MS, MS/MS)

Application:

• Quantification and identification of small molecules and impurities
• Quantification of large molecules, aggregates, peptides, free amino acids, nucleotides, lipids and carbohydrates
• Identification of targeted compounds (proteins, peptides, amino acids, nucleotides, lipids and carbohydrates)
• Peptide mapping and N- C- terminal sequencing (Qtof-MS + Bioconfirm on digested protein)
• Characterization of aggregates (SEC/HPLC; MS ); Charge variants (i.e. basic and acid variants in monoclonal antibodies IEX/HPLC; MS)
• Disulphide bond determination (LC/MS)
• Profiling and determination of relative amounts of sialylated and neutral glycans (WAX/HPLC)

Instrumentation:

• Capillary Electrophoresis (CE coupled by UV, PDA, LIF)

Application:

• Isoelectric point determination
• Protein Purity determination
• Impurity determination with low/high molecular weights
• Quantification of glycosylation grade in proteins

Instrumentation:

• Gel Electrophoresis (coupled by GelDoc, ChemiDoc)

Application:

• SDS-PAGE and Native page (Molecular Weight, Purity Profile)
• IEF (Isoform pattern and Isoelectric Point)
• Dot Blot and Western Blot (Identity, Immunochemical properties evaluation)

Instrumentation:

• Ion Chromatography (IC coupled by PAD, CD)

Application:

• Inorganic cations and anions
• Small organic ions
• Analysis of carbohydrates, sugar alcohols, glycosaminoglycans (GAGs), aminoglycosidic antibiotics (Gentamicin), β-cyclodextrin

Instrumentation:

• Gas Chromatography (GC coupled by FID, TCD, MS)

Application:

• Determination and quantification of volatile and semivolatile molecules HS-GCMS and GCMS)
• Determination and quantification of residual solvents
• Identification of degradation products (composition of fatty acids)
• Extractables and leacheables determination and quantification

Instrumentation:

• Elemental Impurities Determination (ICP coupled by OES, MS and AAS)

Application:

• Elemental impurities (ICH Q3D) determination and quantification in complex matrices, after digestion program.

Instrumentation:

• Spectrophotometry (UV-VIS, Fluorimeter, Luminescence)

Application:

• Total protein determination (Optical density, BCA and Bradford Tests)
• Extinction coefficient evaluation (UV-vis)

Instrumentation:

• Spectroscopy (IR, FT-IR, ATR)

Application:

• Identity tests by comparability through matching score (Raw Materials)

Instrumentation:

• Physical Characterization

Application:

• Dynamic Light Scattering (DLS)
• Dissolution Apparatus
• Osmolality and Osmolarity
• Densitometry
• Viscosity
• pH Determination
• Polarimetry
• Refractive Index
• Total Nitrogen Determination (Kjeldhal)
• Total and Sulfuric Ash
• Degree of Coloration
• Degree of Opalescence Nephelometry
• Sub-visible Particle Counter
• Particle Size Characterization
• Water determination (KF and Coulometer)
• Loss on Drying
• Titration systems
• Thin Layer Chromatography
• Conventional Chemistry