Assessing immunogenicity is a cornerstone of modern drug development, especially for biologics and vaccines. Understanding how the immune system interacts with therapeutic agents is essential to ...

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 ...

Propanc Biopharma Inc. announced that key analytical development activities are underway, including immunogenicity assay feasibility, pharmacokinetic method optimization and stability testing, ...

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 ...

Genalyte, Inc. has announced the launch of its MT-ADA™ anti-drug antibody (ADA) immunogenicity assay designed to run on the Maverick™ Detection System. This test combines screening for the presence of ...

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 ...

A new study published in the journal Vaccines evaluated if re-freezing coronavirus disease 2019 (COVID-19) mRNA vaccine vials preserved the immunogenicity. If re-freezing does not affect vaccine ...

A phase 4 randomised trial in India found the one-week IPC intradermal rabies regimen did not meet prespecified equivalence ...

MELBOURNE, Australia, Oct. 30, 2026 (GLOBE NEWSWIRE) -- (Nasdaq: PPCB) (“Propanc” or the “Company”), a biopharmaceutical company focused on developing novel treatments for chronic diseases including ...