Services

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

• Overview of analysis of particles and aggregates
• Hydrodynamic properties
• Aggregate and particle characterization (soluble aggregates and submicron, subvisible, visible particles)

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