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Immunogenicity
We assess the immunogenicity of your genetic medicines and biologic therapies throughout the preclinical and clinical stages.
Evaluating Immunogenicity in Genetic Medicines and Biologics
Characterizing immunogenicity is critical to developing safe and effective therapies. Antibodies against adeno‑associated viruses (AAVs), whether from natural infection or vector administration, can impact therapeutic efficacy. Neutralizing antibodies, in particular, can diminish the effectiveness of AAV-based treatments. Immune responses can range from no clinical effect to severe, life-threatening reactions involving innate and adaptive immunity.
World-Class Immunology Support for Your Research and GLP Projects
Our team has helped establish the immunobiology foundation of in vivo gene therapy and vaccines, with over 130 published papers to date. We bring extensive experience supporting preclinical studies across a variety of species, including rodents, minipigs, and nonhuman primates, as well as clinical studies in humans. Franklin Biolabs’ Immunology Core serves as a global reference laboratory, offering validated assays for the comprehensive evaluation of humoral and cellular immune responses before and after therapy administration.
Immunogenicity Services
Anti-AAV Capsid Humoral ResponseWe offer AAV Neutralizing Antibody (NAb) and Binding Antibody (BAb) assays across a range of AAV serotypes, species, and biological matrices.
IFN-γ ELISpot AssayT cell response evaluations are available for multiple species. Services include procurement and qualification of peptide libraries.
Lymphocyte IsolationWe provide lymphocyte isolation services from whole blood, liver, spleen, bone marrow, and lymph node.
Anti-AAV Capsid Humoral ResponseWe offer AAV Neutralizing Antibody (NAb) and Binding Antibody (BAb) assays across a range of AAV serotypes, species, and biological matrices.
IFN-γ ELISpot AssayT cell response evaluations are available for multiple species. Services include procurement and qualification of peptide libraries.
Lymphocyte IsolationWe provide lymphocyte isolation services from whole blood, liver, spleen, bone marrow, and lymph node.
Assay Development and ValidationCustom assay development is available for NAb, BAb, and ELISpot assays, including support for novel serotypes, various species, and regulated (GLP) studies.
GLP-Compliant ServicesGood Laboratory Practice (GLP)-compliant assays are available for early-phase clinical programs. We offer program-specific assay and reagent validation under GLP, with expert consultation.
Assay Development and ValidationCustom assay development is available for NAb, BAb, and ELISpot assays, including support for novel serotypes, various species, and regulated (GLP) studies.
GLP-Compliant ServicesGood Laboratory Practice (GLP)-compliant assays are available for early-phase clinical programs. We offer program-specific assay and reagent validation under GLP, with expert consultation.
Meet Our Team
Marcela Salazar Werner, PhD
Senior Director, Immunology
Marcela Salazar Werner, Ph.D. serves as the Senior Director of Immunology at Franklin Biolabs. Marcela is a life sciences R&D leader with more than 15 years of experience advancing immunology, oncology, and cell and gene therapy programs from discovery through clinical development. Her work has advanced cancer immunotherapies, AAV-based gene therapies, and vaccine platforms, while deepening understanding of immune mechanisms underlying therapeutic efficacy and safety. Marcela is an accomplished translational scientist, having authored more than 20 peer-reviewed publications and is recognized for building high-performing teams and translating complex science into clinical impact.
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Advance Your Research with Our Immunogenicity Experts
Our experts are here to support your preclinical and clinical programs with extensive immune response evaluation.
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