The Vaccine Analytics and Formulation Center (VAFC) provides a wide variety of services for analytical characterization and formulation development of vaccine and biotherapeutic candidates.  

The VAFC provides these services to clients and collaborators via research grants or fee-for-service contracts.

Analytical/Preformulation Characterization Studies

1. Primary structure/posttranslational modifications

  • Intact MS
  • LC-MS Peptide mapping
  • Charge heterogeneity
  • Glycoprotein analysis

2. Higher-Order Structural Integrity and Conformational Stability

  • Secondary structure and stability
  • Tertiary structure and stability
  • Quaternary structure and stability

3. Aggregation /Particle Formation

4. Protein-protein interactions, protein self-association and solubility studies

  • Dynamic and static light scattering
  • Viscosity measurements
  • High-throughput PEG and ammonium sulfate precipitation (relative solubility)

5. Immunochemical and cell-based in vitro potency assays

  • Elisa/Octet immunochemical assays
  • Real-time qPCR (infectivity and genome) assays
  • Cell-based viral plaque, TCID50, FFA, FFU assays

Developability and Comparability Assessments

(physicochemical and in vitro potency assessments of vaccines and biotherapeutics):

  • Discovery candidates into development
  • Early-stage development candidates into Ph1 clinical trials
  • Late-stage development candidates into late-phase clinical trials

Formulation Development

  • Forced degradation/mechanism of degradation studies
  • Develop stability-indicating assays
  • High-throughput excipient screening and formulation design
  • Liquid and lyophilized formulation development
  • Accelerated and real-time stability studies
  • Vaccine antigen-adjuvant interaction studies
  • Multi-dose formulations/preservatives

Live Virus and Bacteria Preformulation Characterization and Formulation Development Studies

  • BL-2/ BL-2+ laboratories/facilities
  • Cell-based potency assays for live virus vaccine and drug candidates
  • Colony forming unit assays for live bacteria
  • Virus particle size, morphology and concentrations measurements
  • Infectious to total particle quantitation (infectivity qPCR and genome qPCR)
  • High-throughput excipient screening and formulation design
  • Liquid and lyophilized formulation development
  • Lyophilization cycle development