Related Experiment Video
Updated: Mar 30, 2026
Development and Validation of an Ultrasensitive Single Molecule Array Digital Enzyme-linked Immunosorbent Assay for Human Interferon-α
Published on: June 14, 2018
Immunogenicity evaluation strategy for a second-generation therapeutic, PEG-IFN-β-1a
Joleen T White1,2, Mary Crossman1, Kelly Richter1
1Biogen, 22 Binney Street, Cambridge, MA 02142, USA.
Aims:
Neutralizing antibodies can diminish clinical efficacy of IFN-β in multiple sclerosis patients. Therefore, monitoring immunogenicity was considered critical during clinical development of a second-generation, pegylated IFN-β product, PEG-IFN-β-1a.
Materials & Methods:
Assays previously used to evaluate immunogenicity of IFN-β-1a were used to assess PEG-IFN-β-1a immunogenicity, with modifications to apply current best bioanalytical practices. A separate testing paradigm was used to monitor antibodies to polyethylene glycol.
Results & Conclusion:
Final assay cut points and relevant titer levels were established in-study. Immunogenicity evaluation strategies for second-generation therapeutics should take into consideration current best bioanalytical practices while retaining consistency with legacy assays to facilitate data comparison and interpretation. This study illustrates challenges in assessing immunogenicity of second-generation therapeutics.
