Press Release

Creative Diagnostics, a leading manufacturer and supplier of antibodies, antigens and assay kits, has announced its AAV Reagent Solutions to the research community for gene therapy, including a comprehensive collection of AAV Antibodies, AAV Antigens and Anti-AAV Antibody ELISA Kits applicable to gene replacement, gene editing and gene silencing.

The first human adeno-associated virus (AAV) was discovered in 1965, as a contaminant of adenovirus (Ad) preparations. AAV belongs to the family Parvoviridae and is a small, non-enveloped DNA virus with a genome of approximately 4.7 kb, making it one of the smallest viruses. The AAV vector is a gene delivery vehicle modified from the AAV genome. The adeno-associated virus genome has an inverted terminal repeat (ITR) sequence at both ends of the genome, where the D sequence is closely associated with efficient release, selective replication and packaging of the viral genome.

Although several AAV-based gene therapy drugs have been approved, the immunogenicity of AAV vectors remains a significant barrier to the use of these drugs in preclinical and clinical studies. For example, humans and non-human primates exposed to wild-type AAV typically carry anti-shell neutralizing antibodies (NAbs) that cross-react with several different serotypes used for gene transfer. After vector inoculation, anti-AAV NAb develops rapidly at high titers and persists for several years, preventing vector re-administration.

Therefore, a clear definition of the baseline immunological parameters of gene transfer is important to ensure accurate interpretation of preclinical and clinical trial results. Methods for detecting AAV immunity include cell-based in vitro TI assays, in vivo TI assays (e.g., in mice), and total antiviral capsid antibody (TAb) tests based on enzyme-linked immunosorbent assays (ELISA). TAb methods can detect inefficient NAb below the threshold for TI detection, but may not detect non-antibody neutralizing factors. In vivo and in vitro TI assays screen samples for anti-AAV, NAb and other factors that regulate the efficiency of AAV transduction.

Creative Diagnostics offers a comprehensive line of AAV antibodies capable of recognizing the entire viral capsid, as well as antibodies targeting AA viral subunits and replicases. Titration ELISA kits for different AAV subtypes are also available. In addition, Creative Diagnostics has developed a series of anti-AAV antibody ELISA kits for the most commonly used AAV serotypes.

For example, the Anti-AAV2 (intact particle) monoclonal antibody (Catalog # CABT-B9062) can specifically detect intact viral particles, including empty and intact capsids. For AAV2 and AAV3, the antibody recognizes conformational epitopes of assembled phage that are not present in denatured and native unassembled phage proteins. Creative Diagnostics has developed various humanized antibodies that exclusively target intact AAV particles.

Creative Diagnostics offers a wide range of quality AAV antibodies for gene therapy. For more information on the new antibodies, please visit https://www.creative-diagnostics.com/aav-for-gene-therapy.htm.

About Creative Diagnostics

Creative Diagnostics is a leading manufacturer and supplier of antibodies, viral antigens, innovative diagnostic components, and critical assay reagents. In addition to providing contract R&D and biologic manufacturing services for diagnostic manufacturers along with GMP biologics manufacturing for the biopharmaceutical market, the company aims to continue to act as a trusted source for all researchers’ assay development and manufacturing needs.

Organisation Profile:
Creative Diagnostics is a leading manufacturer and supplier of antibodies, viral antigens, innovative diagnostic components, and critical assay reagents. We provide contract biologic R&D and manufacturing services to the diagnostic manufacturers along with GMP biologics manufacturing for the biopharmaceutical market. Our goal is to be a trusted source for all your assay development and manufacturing needs.