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.

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.

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