HTL Biosolutions
Biotechnology contract research organization providing analytical and development services focused on protein and peptide therapeutics. Core activities include formulation development, higher-order structure and biophysical characterization, aggregate and particle analysis, chromatographic and mass-spectrometry-based molecular characterization, and regulatory/CMC support for biopharmaceutical programs.
Industries
Nr. of Employees
small (1-50)
HTL Biosolutions
Products
Formulation Development
Development of liquid and lyophilized protein and peptide formulations, including stability analysis.
Higher-Order Structure Characterization
Analysis of the secondary and tertiary structures of biomolecules to assess their conformation and stability.
Sedimentation Velocity Analytical Ultracentrifugation (SV-AUC)
Technique to analyze the size, shape, and interactions of biomolecules in solution by measuring their sedimentation behavior under centrifugal force.
Circular Dichroism (CD) Spectroscopy
Analytical method to study chiral properties and higher-order structures of biomolecules, including proteins and nucleic acids.
Capillary Isoelectric Focusing (cIEF)
Technique to separate biomolecules based on their isoelectric points, enabling analysis of charge variants and pI values.
Micro-Flow Imaging (MFI) and FlowCam
Flow imaging microscopy techniques to visualize and analyze particles and microparticles in liquid samples.
Formulation Development
Development of liquid and lyophilized protein and peptide formulations, including stability analysis.
Higher-Order Structure Characterization
Analysis of the secondary and tertiary structures of biomolecules to assess their conformation and stability.
Sedimentation Velocity Analytical Ultracentrifugation (SV-AUC)
Technique to analyze the size, shape, and interactions of biomolecules in solution by measuring their sedimentation behavior under centrifugal force.
Circular Dichroism (CD) Spectroscopy
Analytical method to study chiral properties and higher-order structures of biomolecules, including proteins and nucleic acids.
Capillary Isoelectric Focusing (cIEF)
Technique to separate biomolecules based on their isoelectric points, enabling analysis of charge variants and pI values.
Micro-Flow Imaging (MFI) and FlowCam
Flow imaging microscopy techniques to visualize and analyze particles and microparticles in liquid samples.
Services
Formulation development
Laboratory development of stable liquid, frozen, and lyophilized formulations for protein and peptide therapeutics.
Stability and forced-degradation studies
Real-time and accelerated stability testing and forced-degradation experiments to identify degradation pathways and quantify degradation products.
Higher-order structure and biophysical characterization
Comprehensive structural analysis using CD, FTIR, Raman, DSC, nanoDSF, and fluorescence to evaluate protein conformation and comparability.
Aggregate and particle analysis
Particle and aggregate characterization using SV‑AUC, DLS, SEC, MFI/flow imaging, HIAC, FTIR and Raman microscopy.
Chromatography and LC‑MS characterization
RP-, IEX-, and SEC-HPLC/UPLC method development and LC‑MS peptide mapping and intact mass analysis for sequence and PTM characterization.
Regulatory and CMC support
Support for CMC-related documentation and filing sections, informed by experience with filing documents and biosimilar programs.
Formulation development
Laboratory development of stable liquid, frozen, and lyophilized formulations for protein and peptide therapeutics.
Stability and forced-degradation studies
Real-time and accelerated stability testing and forced-degradation experiments to identify degradation pathways and quantify degradation products.
Higher-order structure and biophysical characterization
Comprehensive structural analysis using CD, FTIR, Raman, DSC, nanoDSF, and fluorescence to evaluate protein conformation and comparability.
Aggregate and particle analysis
Particle and aggregate characterization using SV‑AUC, DLS, SEC, MFI/flow imaging, HIAC, FTIR and Raman microscopy.
Chromatography and LC‑MS characterization
RP-, IEX-, and SEC-HPLC/UPLC method development and LC‑MS peptide mapping and intact mass analysis for sequence and PTM characterization.
Regulatory and CMC support
Support for CMC-related documentation and filing sections, informed by experience with filing documents and biosimilar programs.
Expertise Areas
- Protein and peptide formulation development
- Higher-order structure and biophysical characterization
- Aggregate and particle analysis
- Chromatographic and mass-spectrometry-based molecular characterization
Key Technologies
- Liquid chromatography–mass spectrometry (LC‑MS)
- Circular dichroism (CD) spectroscopy
- Fourier-transform infrared (FTIR) spectroscopy and microscopy
- Raman spectroscopy