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 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 ...

This article is based on a poster originally authored by Ebru Aydin Kurtulmus, Dagmar Hildebrand, Fiordiligie Casilag, Verena Banschbach, Jessica Heckmann, Sarah Schott, Marc Botcherby and Volker ...

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 ...

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

A new article in the journal Nucleic Acid Therapeutics addresses the recognition by the U.S. Food and Drug Administration ...