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Comparative immunogenicity is a key regulatory requirement for biosimilars. In a streamlined biosimilar development process, absent a comparative clinical efficacy study, the analytical data and clinical pharmacokinetics (PK) study need to provide sufficient evidence for a conclusion of comparable immunogenicity. In this case study, we have reviewed the role of analytical and clinical data in [...]

Therapeutic protein administration in both preclinical and clinical studies can result in the formation of anti-drug antibodies against the therapeutic protein. Anti-drug antibody formation may alter the pharmacokinetics of the therapeutic protein, reduce its plasma concentrations, increase exposure variability, and may lead to a loss of efficacy and adverse events. In an effort to quantitatively [...]

Polyethylene glycol (PEG) has been widely used in household products from skin care and cosmetics, to baby wipes and cleaners, as well as protein biotherapeutics. More recently, PEG has become a critical component of lipid nanoparticles (e.g., LNP or Accurin platforms) used to deliver small molecule and ribonucleic acid (RNA) therapeutics. A potential concern with [...]

Immunogenicity of a therapeutic protein product may elicit an unintended immune response, and is a critical aspect evaluated in oncology clinical trials. The development of anti-drug antibodies (ADAs) can impact the pharmacokinetics, pharmacodynamics, efficacy, and safety of these therapies. We review the background and nomenclature of immunogenicity assessment in oncology studies and emphasize the complexities [...]

Vaccines are among the greatest achievements of modern medicine, and have saved countless lives. Subunit vaccines are vaccines made from specific parts (subunits) of a pathogen. Compared other types of vaccines, such as inactivated and live-attenuated vaccines, they are generally safer and more suitable for individuals with weakened immune systems. However, their immunogenicity is typically [...]