At BioSpring, we go beyond standard oligonucleotide analytics by offering specialized services tailored to complex formulations, physicochemical properties, and biological activity. Our advanced analytical techniques provide comprehensive insights to support the development of innovative nucleic acid-based therapeutics.
Dose-formulation analysis
Ensuring the stability, consistency, and bioavailability of nucleic acid drug formulations is critical for therapeutic success. Our dose-formulation analysis includes:
Quantitative and qualitative assessment of oligonucleotide content in final formulations
Detection of degradation products, impurities, and excipients interaction studies
Stability testing under various conditions to evaluate formulation robustness
Compliance with regulatory requirements for drug product characterization
Characterization of Oligonucleotides in Complex Formulations
Oligonucleotide-based drugs often require advanced delivery systems such as lipid nanoparticles (LNPs), polymeric carriers, or conjugates for targeted delivery. Our expertise includes:
Analytical methods to evaluate oligonucleotide integrity and release profiles in complex matrices
Compatibility studies to assess interactions between oligonucleotides and formulation excipients
Particle size distribution, encapsulation efficiency, and release kinetics measurements
Tailored strategies for characterizing innovative delivery systems
Physicochemical Characterization of Oligonucleotides in Solution
Understanding the structural and thermodynamic properties of oligonucleotides is essential for optimizing stability and performance. We offer:
Differential Scanning Calorimetry (DSC) to study melting temperature (Tm) and thermodynamic stability
Spectroscopic methods such as UV-Vis, fluorescence, and circular dichroism (CD) for structural analysis
Dynamic Light Scattering (DLS) for size distribution and aggregation assessment
pH and ionic strength dependency studies for buffer optimization
In Vitro Bioactivity Assays
Confirming the biological functionality of nucleic acid therapeutics is a key step in drug development. Our bioactivity assays include:
Cell-based assays to evaluate target engagement, cellular uptake, and intracellular stability
Reporter gene assays for measuring transcriptional or translational activity upon oligonucleotide treatment
Immune response profiling, including cytokine release and Toll-like receptor (TLR) activation studies
Custom assay development to match specific therapeutic mechanisms
By integrating cutting-edge analytical techniques with extensive experience in oligonucleotide therapeutics, we provide the highest level of precision and reliability in characterizing nucleic acids throughout their lifecycle.
