Methods Development

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 assesment

PROCESS ANALYTICAL CHEMISTRY (PAC)

• Method development for 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

SYNTHESIS

• Custom synthesis
• Analytical standard synthesis and/or purification
• Metabolites synthesis and/or purification
• Enzyme substrate synthesis and/or purification
• Derivatization of polymers

Polymer Characterization and Polymer Derivatization

QUANTITATIVE SOLUBILITY MAPPING (QSM)

The solubility of polymers are measured by various analytical methods under systematically selected solvent conditions.  The measured polymer solubility values are displayed in a solubility map.  Since the solubility data are quantitative, a Quantitative Solubility Map can be constructed.  The solubility values of drug substances can be also measured and displayed on the QSM. 

The generated QSM can be an irreplacable tool for formulation, extraction optimization and analytical method development.

QSM allows the experimental determination of solubility parameters (Hildebrand and Hansen).

SUBJECTS

• 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

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 and Analysis

PROTEIN SOLUBILITY MAPPING

• pH and ionic strength relationship

SEPARATION

• Reversed phase separation (RPLC)
• Size exclusion chromatography (SEC, GPC) 
• Identification of on column conformational changes
• Optimization of native protein recovery

PURIFICATION

• Reversed phase (RPLC)
• Size exclusion (SEC)
• Ion exchange (IEX)
• Hydrophobic Interaction Chromatography (HIC)

ANALYSIS

• Purity determination (HPLC, SDS-PAGE, CGE)
• Protein aggregation studies (HPLC, LIGHT SCATTERING, PARTICLE SIZING) 
• Capillary Electrophoresis (CE)
• Capillary Gel Electrophoresis (CGE)
• Capillary Isoelectric Focussing (CIEF)
• HPLC and Capillary Electrophoresis based analytical method development

BIOTECHNOLOGY

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

• Mammalian protein synthesis
• Protein characterization
• Protein purification development
• Protein formulation development
• Protein analytical method development