Melissa Triggiano, M.S.

Melissa’s career started in a T cell immunology research lab at Duke University Medical Center where she developed comprehensive immune profiling assays utilizing polychromatic flow cytometry and cytokine multiplexing to identify signatures in a variety of clinical indications including cancer, pulmonary disease, and solid organ transplants pre- and post-treatment. Additionally, she worked closely with the Duke Pratt School of Engineering to design and perform novel single cell immune assays and magnetic labeling for lab-on-chip applications.

After that, Melissa joined Precision BioSciences where she was responsible for leading a team of researchers within the Cell Therapy CMC Analytical group. In this capacity, she served as the technical subject matter expert in bioassay and flow cytometry method development for Precision’s ARCUS gene-edited allogeneic CAR-T cell therapy programs, including PBCAR0191, PBCAR20A, PBCAR269A, and PBCAR19B. Melissa developed several highly novel deep characterization and QC-ready analytical methods in support of in-process control and drug product release. Before assuming this role, Melissa was one of the original team members of the CAR-T process research and development team and played a significant part in the early development of the company’s allogeneic CAR-T platform.

From there, Melissa went to OrganaBio where she led Immunology Process and Product development. At OrganaBio, Melissa leveraged the company’s propriety supply chain of perinatal tissue to develop processes to isolate HSC, NK, and T cells from cord blood and placental tissue. Melissa also developed comprehensive flow cytometry panels to phenotype each cell type to market them to cell and gene therapy drug developers. In addition, Melissa served in an outward facing role to support generation of SOWs for process development work and response to RFPs for GMP work for its prospective customers.

Immediately prior to joining DHC, Melissa was leading MS&T and Analytical Development at Cytovia Therapeutics. Melissa was one of the first members of the scientific team and worked closely with Cytovia’s  external collaborators to document and internalize the un-edited and TALEN gene-edited iPSC-derived NK cell manufacturing processes. Subsequently, Melissa led the technology transfers of the manufacturing process into Cytovia’s new internal R&D and GMP manufacturing facilities. Melissa simultaneously identified and led the development and qualification of all the necessary in-process and release methods, including flow cytometry, qPCR, and bioassays.

At DHC, Melissa has particularly enjoyed providing process and analytical development guidance and solutions for early and late-stage developers of gene-edited cell therapy products.

• CMC gap analyses and risk assessments against IND and BLA readiness
• Analytical and process development strategic support for early and late-stage programs
• Authorship of regulatory submissions including DMF, CATT, INTERACT, pre-IND, Type C, Type D, IND, and BLA regulatory submissions

‍

• MacLeod D.T., Antony J, Martin A.J., Moser R.J., Hekele A, Wetzel K.J., Brown A.E., Triggiano M.A., Hux J.A., Pham C.D., Bartsevich V.V., Turner C.A., Lape J, Kirkland S, Beard C.W., Smith J, Hirsch M.L., Nicholson M.G., Jantz D and McCreedy B. (2017), Integration of a CD19 CAR into the TCR alpha chain locus streamlines production of allogeneic gene-edited CAR T cells. Molecular Therapy, DOI:10.1016/j.ymthe.2017.02.005
• Abedini-Nassab, R., Joh, D. Y., Triggiano, M. A., Baker, C., Chilkoti, A., Murdoch, D. M. and Yellen, B. B. (2016), Magnetophoretic Conductors and Diodes in a 3D Magnetic Field. Advanced Functional Materials, 26: 4026–4034. DOI:10.1002/adfm.201503898
• Abedini-Nassab, R., Joh, D. Y., Van Heest, M. A., Yi, J. S., Baker, C., Taherifard, Z., Margolis, D. M., Garcia, J. V., Chilkoti, A., Murdoch, D. M. and Yellen, B. B. (2015), Characterizing the Switching Thresholds of Magnetophoretic Transistors. Advanced Materials, 27: 6176–6180. DOI:10.1002/adma.201502352

• Certified Lean Six Sigma Black Belt (SSGI – LSSBB)
• Process Validation (ISPE)

Cytovia Therapeutics
Associate Director, MS&T and Analytical Development
Senior Manager, MS&T and Analytical Development

OrganaBio, LLC
Manager, Immunology Process and Product Development

Precision BioSciences, Inc.
Scientist I, Cell Therapy BioAnalytical Development
Associate Scientist, Cell Therapy BioAnalytical Development
Research Associate, Cell Therapy BioAnalytical Development
Research Assistant, Cell Therapy Process Development

Duke University Medical Center
Laboratory Research Analyst
Research Technician II

University of Florida
M.S. in Medical Microbiology and Biochemistry, Concentration in Cell Science

North Carolina State University
B.S. in Biological Sciences, Concentration in Human Biology, Minor in Business Administration