The US Food and Drug Administration (FDA) on Wednesday finalized guidance to help industry develop and validate immune assays for the assessment of the immunogenicity of therapeutic protein products ...

The use of biologic-based therapeutics has revolutionized our ability to treat complex diseases such as cancer- and autoimmune-related disorders. Biologic-based therapeutics are known to generate anti ...

The assessment of immunogenicity in biotherapeutics is crucial to ensuring both the safety and efficacy of these advanced medicinal products. By detecting anti-drug antibodies (ADAs) and understanding ...

Gyros Protein Technologies AB, a pioneer in automated nanoliter-scale immunoassays and a leading provider of peptide synthesizers and reagents, today announced the introduction of Gyrolab ® Generic ...

As biologics and biosimilars continue to reshape oncology, ensuring their safety and efficacy remains a top priority. In this expert-driven report, Cerba Research examines the latest advancements in ...

FDA grants Breakthrough Device Designation to BioAgilytix’s anti-AAV antibody assay supporting Lexeo’s gene therapy for Friedreich ataxia. DURHAM, NC, UNITED ...

Cellular immunogenicity and immunotoxicity assays help scientists design, validate, and translate therapeutic research into treatments that weaponize the immune response against cancer.

Delivering cutting-edge peer-reviewed research on using nucleic acids and related compounds to alter gene expression for therapeutic purposes. A new article in the peer-reviewed journal Nucleic Acid ...

The Single-antigen Bead (SAB) assay has revolutionized the detection of anti-HLA antibodies, which are critical in transplantation medicine. Despite its advantages, several limitations and challenges ...

Boca Raton, Florida, April 23, 2024 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (INMB) (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the ...