Protein & Product Analysis

analysis

Analytical labs, equipped with high-end protein and product analytics for bio-therapeutics, follow-on biologics, Antibody Drug Conjugates (ADCs) and cytotoxic drug products.

State-of-the-art biopharmaceutical analytics to characterize proteins, products and processes.

Biopharmaceutical development relies on high-end protein analytics as a fundamental prerequisite to characterize protein drug substances, drug products and processes. We are at your disposal to implement your existing methods or will gladly develop methods tailored specifically to your project.

Protein analytics / ADCs

  • Protein electrophoresis, chromatography, spectroscopy
  • Assymetric flow field-flow fractionation of soluble and non-soluble aggregates (AF4)
  • Multi-angle laser light scattering (MALS) to determine┬áthe absolute molecular masses of monomeric protein and aggregates
  • Determination of second virial coefficient of proteins using laser light scattering for describing protein-protein interaction in solution
  • Determination of protein complex strength (KD) and complex stoichiometry by means of composition gradient multi-angle light scattering (CG-MALS) to characterize protein-protein complex formation
  • Differential scanning calorimetry (nanoDSC) for describing protein thermodynamics

Cytotoxics / ADCs

  • HPLC analytics in respect to content an purity with UV-Vis and conductometic detection
  • determination of antibody drug ratio (ADR)
  • determination of unconjugated cytotoxic drug substance

Drug product analytics

  • Selective coulometric Karl-Fischer titration to discriminate and quantify residual and crystal water in lyophilizates
  • Determination of residual solvent in lyophilizates by head space gas chromatography (HS-GC)
  • Differential scanning calorimetry (DSC) for identification of 1st and 2nd order thermal transitions in protein solutions and freeze dried products
  • Scanning electron microscopy SEM for structure analysis of lyophilizates
  • Determination of visible and subvisible particles in parenteral products
  • Measurement of clarity and degree of opalescence of liquid formulations and reconstituted lyophilizates
  • Syringeability measurement, in particular for high concentration protein formulations and liposomal products
  • Plunger-stopper break-loose force and gliding force measurement for prefilled syringes

Process analytical technologies (PAT)

  • Methods to design, analyze and control pharmaceutical manufacturing processes through the measurement of critical Process Parameters in pilot scale

Stability tests

  • Assessment of product shelf life by accelerated and real-time stability studies
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