What we do
Analytical Services
We offer a broad range of analytical services to help you speed-up your drug product development.
Colloidal and conformational stability analysis
Stability of a drug product is essential for development and commercial success. Leukocare utilizes Dynamic- and Static Light Scattering to understand the colloidal stability of therapeutic proteins. These techniques are applied to determine important parameters like diffusion interaction coefficient (kD) or second virial coefficient (B22) which give information on the self-aggregation tendencies of protein
Critical temperature analysis
Differential Scanning Calorimetry is used as a thermal analysis technique. Leukocare applies it to determine Tg & Tg´ for the analysis of lyo products. Further, it can be used to determine thermodynamic stability of liquid formulations.
Thermal stability of a protein is an important attribute and correlates to its long-term storage stability. Therefore, temperature scanning techniques like Differential Scanning Calorimetry or Nano Differential Scanning Fluorimetry are utilized to determine critical temperatures of drug substances. This can be applied to screen for favorable buffer conditions or excipient combinations.
Molecular Modeling
Molecular modeling of a target drug substance is an important in-silico tool to predict the biological effects and behaviors of molecules and results in a complete picture of a protein’s structure, providing valuable information on degradation hot-spots like aggregation-prone regions, hydrophobic patch areas, or areas of high charge density. These are important predictors for chemical and colloidal stability.
Molecular purity and integrity analysis
Leukocare offers the whole range of HPLC including SEC-MALS. These methods are critical for determining molecular purity and integrity with high precision and reproducibility. HPLC can detect degradation products such as aggregation or chemical modifications of the DS. Determining degradation pathways is an essential first step towards the development of a stable drug product.
Particle Characterization
Detection and measurement of particles are important when developing a drug product. Leukocare applies different methods for identification, size determination, and characterization of particles such as sub-visible particle analysis by FlowCam®, Microscopy-guided Raman Spectrometry, and Laser-Induced Breakdown Spectroscopy (LIBS).
Size and size distribution are an essential CQA for many novel drug delivery systems, like mRNA-LNPs. Such delivery systems are often complex colloidal systems in the size range of tens to hundreds of nanometers. Leukocare provides the tools and expertise for characterization and quantification of these modalities, applying Light scattering techniques (DLS/SLS), as well as nanoparticle tracking analysis.
Colloidal and conformational stability analysis
Stability of a drug product is essential for development and commercial success. Leukocare utilizes Dynamic- and Static Light Scattering to understand the colloidal stability of therapeutic proteins. These techniques are applied to determine important parameters like diffusion interaction coefficient (kD) or second virial coefficient (B22) which give information on the self-aggregation tendencies of protein
Critical temperature analysis
Differential Scanning Calorimetry is used as a thermal analysis technique. Leukocare applies it to determine Tg & Tg´ for the analysis of lyo products. Further, it can be used to determine thermodynamic stability of liquid formulations.
Thermal stability of a protein is an important attribute and correlates to its long-term storage stability. Therefore, temperature scanning techniques like Differential Scanning Calorimetry or Nano Differential Scanning Fluorimetry are utilized to determine critical temperatures of drug substances. This can be applied to screen for favorable buffer conditions or excipient combinations.
Molecular Modeling
Molecular modeling of a target drug substance is an important in-silico tool to predict the biological effects and behaviors of molecules and results in a complete picture of a protein’s structure, providing valuable information on degradation hot-spots like aggregation-prone regions, hydrophobic patch areas, or areas of high charge density. These are important predictors for chemical and colloidal stability.
Molecular purity and integrity analysis
Leukocare offers the whole range of HPLC including SEC-MALS. These methods are critical for determining molecular purity and integrity with high precision and reproducibility. HPLC can detect degradation products such as aggregation or chemical modifications of the DS. Determining degradation pathways is an essential first step towards the development of a stable drug product.
Particle Characterization
Detection and measurement of particles are important when developing a drug product. Leukocare applies different methods for identification, size determination, and characterization of particles such as sub-visible particle analysis by FlowCam®, Microscopy-guided Raman Spectrometry, and Laser-Induced Breakdown Spectroscopy (LIBS).
Size and size distribution are an essential CQA for many novel drug delivery systems, like mRNA-LNPs. Such delivery systems are often complex colloidal systems in the size range of tens to hundreds of nanometers. Leukocare provides the tools and expertise for characterization and quantification of these modalities, applying Light scattering techniques (DLS/SLS), as well as nanoparticle tracking analysis.