Services

ANALYSIS & APPLICATIONS

  • Analysis of small organic pharmaceuticals (drug substance)
  • Formulation polymer characterization
  • Polymer pharmaceuticals characterization
  • Biopharmaceutical products analysis
  • Protein aggregation studies 
  • Complex formulation analysis (drug product)
  • Particle size distribution measurement of formulations
  • Particle stability assessment
  • Process analytical chemistry (PAC)

POLYMER SOLUBILITY STUDIES

  • Polymer solubility measurements
  • Polymer solubility mapping

DRUG SUBSTANCE EXTRACTION  (METHOD DEVELOPMENT AND OPTIMIZATION) 

  • Drug substance solubility measurement
  • Drug substance extraction from complex tablet or capsule formulations
  • Drug substance recovery optimization
  • Drug substance and polymer solubility matching

PARTICLE SIZE DISTRIBUTION AND PARTICLE COUNTING

  • Particle size determination
  • Particle size distribution
  • Particle size changes during processes

PROTEIN ADSORPTION STUDIES

  • Protein adsorption isotherm determination
  • Protein adsorption to surfaces
  • Protein conformational changes at solid interfaces

LIPOSOMES RELATED STUDIES

  • Liposome design
  • Liposome characterization (Composition, Size and Size Distribution)
  • Liposome preformulation
  • Active ingredient embedding optimization
  • Embedding efficiency measurements
  • Protein embedding
  • Solubility screening for chemical libraries

POLYMER CHARACTERIZATIONS
 
QUANTITATIVE SOLUBILITY MAPPING (QSM)


The solubility of polymers is measured by various analytical methods at systematically selected solvent conditions.  The measured polymer solubility values are displayed in a Quantitative Solubility Map. 

The solubility values of drug substances can be also measured and displayed on the QSM. 
The generated QSM can be an irreplaceable tool for formulation, extraction optimization and analytical method development.
QSM allows the experimental determination of solubility parameters (Hildebrand and Hansen).
 

Studied Polymers

Polymers and polymer derivatives

Polyethylene Oxides (PEO) , Polyethylene Glycols (PEG), Polyvinyl Alcohols (PVA), Hydroxyl Propyl cellulose (HPC), Hydroxyl Propyl methyl cellulose (HPMC), Polyvinyl Alcohol (PVA), Polyvinyl Pyrrolidone (PVP), Opadry characterization

Proteins and Polypeptides

EXPERIMENTAL METHODS AND TECHNIQUES

  • Chromatography GPC, SEC, RPLC, Ion Exchange Chromatography (IEX)
  • Dynamic Light Scattering 
  • Viscosity
  • High Performance Capillary Electrophoresis (HPCE), SDS and Native Gel Electrophoresis


PROTEIN SEPARATION, PURIFICATION, CHARACTERIZATION AND ANALYSIS
PROTEIN SOLUBILITY MAPPING

  • pH and ionic strength relationship on solubility studies, screening

 

CHARACTERIZATION AND ANALYSIS METHODS AND TECHNIQUES

  • Purity determination (HPLC, SDS-PAGE, CGE)
  • Protein aggregation studies (HPLC, LIGHT SCATTERING, PARTICLE SIZING) 
  • Protein conformational analysis
  • Identification of on column conformational changes
  • Capillary Electrophoresis (HPCE)
  • Capillary Gel Electrophoresis (HP CGE)
  • Capillary Isoelectric Focussing (HP CIEF)
  • HPLC and Capillary Electrophoresis based analytical method development
  • Protein purification

BIOTECHNOLOGY
In collaboration with our partners we can provide full biotechnology service,

  • Protein characterization
  • Protein purification development
  • Protein formulation development
  • Protein analytical method development

IMMUNE TOXICITY ASSESMENT

  • In vitro and in vivo studies
  • Complement activation
  • CARPA