The Vaccine Analytics and Formulation Center (VAFC) laboratories are located in the Multidisciplinary Research Building on the West Campus of the University of Kansas.
The state-of-the-art Main Laboratories are used to perform analytical characterization and formulation development studies with a wide variety of vaccine antigens and biotherapeutic drug candidates. Analytical capabilities include biochemical, biophysical and immunochemical equipment to measure the structural integrity, conformational stability, solubility, and aggregation propensity of biomolecules (see equipment section). The main labs are also used to setup (1) high-throughput excipient screening experiments to design candidate formulations, and (2) various stability studies to compare the real-time and accelerated stability profiles of biomolecules in different formulations.
Specialized Laboratories are organized to support specific analytical and formulation development work including the following capabilities (also see equipment section):
- Biological Safety Level 2/2+ Laboratories are dedicated facilities for live virus formulation studies including tissue culture labs to perform a variety of in vitro cell-based potency assays. The BL2/2+ labs are also well equipped for virus particle characterization and formulation studies including lyophilization.
- Biological Safety Level 2 Laboratory for live bacteria formulation studies including in vitro cfu/mL potency assays as well as antimicrobial effectiveness studies with preservatives to develop multi-dose formulations.
- The Mass Spectroscopy Laboratory is equipped with two mass spectrometers used for intact mass and LC-MS peptide mapping analysis of the primary structure and post-translational modifications of biomolecules.
- The Lyophilization Laboratory includes bench-scale and pilot-scale freeze-dryers for formulation development and lyophilization cycle development studies for biomolecules as well as live virus/bacteria candidates.
- The Particle Laboratory includes a combination of static and dynamic light scattering instruments and particle imaging techniques to count, size and characterize biomolecules, viral vectors and vaccine adjuvants as well as their physical degradation products (e.g., aggregates).