A5028250293- Protein purification and stability
- Freezing and Crystallization Processes
- Viral Infectious Diseases and Gene Expression in Insects
- nanoparticles nucleation surface interactions
- Material Dynamics and Properties
- Microbial Inactivation Methods
- Microencapsulation and Drying Processes
- Drug Solubulity and Delivery Systems
- Crystallization and Solubility Studies
- Microfluidic and Capillary Electrophoresis Applications
- Atmospheric chemistry and aerosols
- Astrophysics and Star Formation Studies
- Microfluidic and Bio-sensing Technologies
- thermodynamics and calorimetric analyses
Bio Forschung Austria
2021
Universität Innsbruck
2016-2021
TU Wien
2016
This study addresses the effect of freezing and thawing on a therapeutic monoclonal antibody (mAb) solution corresponding buffer formulation. Particle formation, crystallization behaviour, morphology changes cryo-concentration effects were studied after varying rates, formulation protein concentration. The impact undergoing multiple freeze/thaw (FT)-cycles at controlled uncontrolled temperature rates mAb solutions was investigated in terms particle formation. Physicochemical characteristics...
Cryoconcentration of an in-house IgG1 and number aggregates in a formulation containing trehalose were determined dependence on freezing protocol volume. Morphology changes ice crystals depending cooling rates captured by optical cryomicroscopy (OCM) images. UV-Vis affinity chromatography (ALC) was used to determine protein content size-exclusion (SEC) for detection aggregates. Cooling − 80°C rather than 20°C is beneficial avoiding hot spots high concentration. An upscaling 250 ml 2 L...
In this work we use Raman spectroscopy for protein characterization in the frozen state. We investigate behavior of therapeutic monoclonal antibody IgG1 formulation upon thawing by spectroscopy. Secondary and tertiary structure three different mab formulations state are followed through observation marker bands α-helix, β-sheet random coil. identify tyrosine intensity ratio I856/I830 as a aggregation. Upon fast cooling (40 °C/min) to -80 °C observe significant increase coil α -helical...
Here we investigate the freezing and thawing properties of aqueous solutions in oil emulsions, with a particular focus on investigating influence surfactant stirring time emulsion. Specifically, employ optical cryomicroscopy combination differential scanning calorimetry to study phase behavior emulsified 25 wt. % ammonium sulfate droplets temperature range down 93 K. We conclude that nucleation does not vary oil-surfactant combination, is, homogeneous is probed. However, incomplete...
Abstract Water is the most important plasticizer of biological and organic hydrophilic materials, which generally exhibit enhanced mechanical softness molecular mobility upon hydration. The enhancement dynamics mixing with water, in glass-forming systems implies a lower glass transition temperature ( T g ), considered universal result In fact, even cases where hydration or humidification an sample stiffer properties, almost always increases increasing water content, its decreases...
Naphthalene was deposited from the vapor phase on ice surfaces at 77 or 253 K to yield strongly distinct behavior, forming either an amorphous glass layer submicrometer-sized crystals, respectively. The results stand upon optical emission spectroscopy combined with differential scanning calorimetry and X-ray analysis. of naphthalene behaves in same manner as inert metallic support: it starts relax 105 crystallizes 185 K. formed microcrystals exhibit absorption behavior surface are thus...
In the pharmaceutical industry, cryoprotectants are added to buffer formulations protect active ingredient from freeze- and thaw damage. We investigated freezing thawing of aqueous sodium citrate with various cryoprotectants, specifically amino acids (cysteine, histidine, arginine, proline lysine), disaccharides (trehalose sucrose), polyhydric alcohols (glycerol mannitol) surfactants (polysorbate 20 polysorbate 80). Hereby, we employed optical cryomicroscopy in combination differential...
We examined the impact of monoclonal antibody (mAb) and buffer concentration, mimicking cryoconcentration found upon freezing in a 2 L bottle, on mAb stability during frozen storage. Upon cryoconcentration, larger protein molecules small excipient freeze-concentrate differently, resulting different to stabiliser ratios within container. Understanding these shifted is essential. For two mAbs set samples with constant (5 mg/mL) or concentration (medium histidine/adipic acid) was prepared...
Abstract Purpose Scale-down devices (SDD) are designed to simulate large-scale thawing of protein drug substance, but require only a fraction the material. To evaluate performance new SDD that aims predict in 2 L bottles, we characterised 3D temperature profiles and changes concentration density comparison 125 mL bottles. Differences diffusion between monoclonal antibody (mAb) histidine buffer after were examined. Methods Temperature at six distinct positions recorded with type T...