Immunogenicity

Understanding immunogenicity is critical to the development of effective and safe advanced therapies, including genetic medicines. Antibodies to adeno-associated viruses (AAVs) can result from natural infection or after vector administration. Neutralizing antibodies can diminish the efficacy of AAV-based genetic medicines. Immune responses to AAV gene therapies or other advanced therapies can range from no clinical effect to severe, life-threatening conditions involving innate and adaptive immune activity. Franklin Biolabs is here to help you assess the immunogenicity of your genetic medicine throughout the preclinical and clinical stages.

Our Expertise

Our team of experts established the immunobiology foundation of in vivo gene therapy/vaccines through more than 130 published papers. We have extensive experience supporting preclinical studies in various species such as rodents, minipigs, and nonhuman primates, as well as clinical studies in humans. The immunology core at Franklin Biolabs is a reference lab available to the global community to evaluate humoral and cellular host immune responses before and after gene therapy administration.

Our Services

Anti-AAV Capsid Humoral Response

AAV Neutralizing (NAb) and Binding Antibody (BAb) assays are available for multiple AAV serotypes, species, and matrices.

IFN-γ ELISpot Assay

Evaluation of T cell responses available for multiple species. Services provided include peptide library procurement and qualification.

Lymphocyte Isolation

Services provided include isolation of lymphocytes from whole blood, liver, spleen, bone marrow, and lymph node.

Assay Development

Assay development services can be provided across NAb, BAb, and ELISpot assays, including novel serotypes, different species, and regulated status.

GLP Options

Good Laboratory Practice (GLP)-compliant tests are available for early-phase clinical programs. Program-specific assay and reagent validation are available for GLP with consultation.