rna characterization aliquots

STABILITY AND CHARACTERIZATION


Our integrated research, formulation, product development, and manufacturing teams work closely together to anticipate challenges that hinder global accessibility and availability of critical immune-enhancing products. 

small plasmid prep

PRODUCT DEVELOPMENT:

  • Macromolecule-based vaccine and biotherapeutic formulations: including liquid, liquid suspension, frozen, lyophilized, and spray-dried product presentations using DoE (Design of Experiments) approach.
  • Vaccine adjuvant, small molecule drug, and biomolecule formulations using pharmaceutically acceptable delivery platforms such as liposomes, emulsions, aluminum salts, or aqueous dispersions.

STABILITY STUDIES:

  • Short-term testing of drug product through add-mix, syringe stability, photochemical, freeze/thaw, shipping/handling, and forced-degradation studies.
  • Real-time and accelerated storage stability studies of lead candidates to enable selection of formulations for manufacture and to predict shelf-life.
in progress freeze/thaw test

CHARACTERIZATION OF SMALL MOLECULES, MACROMOLECULE, AND VACCINE ADJUVANT FORMULATIONS

  • Physicochemical characterization, solubility screening, high throughput excipient screening, and forced degradation studies for macromolecule-based drug products including recombinant proteins, VLPs, viral vectors, and RNA.
  • Physicochemical characterization of nanoparticles using Dynamic Light Scattering, laser diffraction, and/or Nanoparticle Tracking Analysis
  • Quantitation of small molecule compounds using reverse phase high performance liquid chromatography.
  • Biophysical characterization of macromolecules including circular dichroism, intrinsic fluorescence, static and dynamic light scattering, SEC-MALS, particle characterization, SDS-PAGE, Native PAGE, ELISA, and UV/Vis analysis.

ANALYTICAL ASSAY DEVELOPMENT

Development of analytical assays to characterize the material of interest, including HPLC assays, ELISA, and other biophysical assays.

qualitative evaluation of analytical assay