Services - Vaccine and Cell Therapy Laboratory

Services

The VCTL is designed with the capability and flexibility to support small scale production of a wide variety of viral and non-viral drug substances and drug products in accordance with current Good Manufacturing Practice (cGMPs) as required by the US Food and Drug Administration (FDA).

The VCTL features a Quality Control Laboratory equipped with state of the art equipment that supports in process testing, validation assays, lot release testing and stability testing. For a complete list of analytical procedures please contact the Facility director or the Associate Director.

Expert immunologists on our team can help design correlative studies plan and endpoints for your clinical protocol and perform both, antigen specific and agnostic and cellular immune-analysis on patient samples on a fee-for service basis.To discuss further contact Facility director or the Associate Director.

VCTL offers services to process and store clinical samples designated for correlative analysis.

Regulatory Documentation
  • Grant Writing
  • Protocol Development
  • Control Documentation
  • CMC Document
  • FDA Submissions
Project Development
  • cGMP SOPs
  • Consulting
  • Optimization
  • Scale Up
  • Validation
  • Qualification
  • Tech Transfer

cGMP Production

Cell-based Therapeutics
  • DCs
  • Macrophages
  • T cells
  • Stem Cells
Cancer Vaccines
  • Peptide
  • mRNA
  • DCs
  • Protein
  • DNA
  • Virus
Infectious Disease Vaccines
  • Rescue
  • MVS
  • Challenge Virus
  • Drug Product
Master Cell Bank
Biobanking
  • PBMCs
  • plasma
  • serum
  • RNA
  • DNA
  • Storage
  • Documentation
  • Audit trail
Cellular Immune Analysis
  • Polyfunctional antigen-specific T-cell responses
  • Epitope deconvolution
  • Functional Killing Assays
  • Neoantigen-TCR identification
    • ICS - flow cytrometry
    • ELISPOTS
    • LDH assay
  • Manuscript