The Vaccine and Cell Therapy Laboratory acts as liaison between Mount Sinai’s clinical staff and the manufacturer of synthetic peptides for use in Phase 1 and 2 clinical trials, monitoring progress during manufacture and coordinating shipments from the manufacturer to the lab. Our production staff is responsible for the reconstitution, aliquoting, and quality control testing of synthetic peptides used in personalized peptide vaccine clinical trials at Mount Sinai. On the days of treatment, the clinical team coordinates with lab staff responsible for preparing peptide mixtures for trial patients.
We follow the U.S. Food and Drug Administration’s (FDA) current good manufacturing practices (cGMP) in our production of cellular and viral products for use in Phase 1 and 2 clinical trials. The staff is experienced in the production of dendritic cell products and hematopoietic stem cell products used in FDA-approved clinical trials performed by faculty at the Icahn School of Medicine at Mount Sinai.
Services We Offer
The Vaccine and Cell therapy Laboratory offers these services to Mount Sinai researchers:
- Perform immune assays to determine key correlates of immunity in response to novel cancer vaccines and immunotherapies
- Process and bank patient specimens for longitudinal analysis
- Design and perform immune assays such as antigen-specific immune cell expansion, intracellular staining, and multicolor flow cytometry and enzyme-linked immune absorbent spot and tetramer assays
- Analyze assay data and report conclusions on these assays
- Provide consultations for designing correlative studies for Phase 1 and Phase 2 clinical trials
