Knowledge Center

Immunogenicity poses a critical risk to all biologics, including monoclonal antibodies, ADCs, recombinant proteins, cell & gene therapies, and mRNA-based therapies. The consequences of immunogenicity can not only endanger patients but also reduce the trea...

This on-demand webinar focuses on strategies to assess the potential for human immune response following the administration of an mRNA therapeutic, the associated LNP and the protein encoded for by the mRNA. In this on-demand webinar you will take away ...

While the reasons for clinical failure vary, a large portion is due to issues with safety and efficacy. Unwanted immunogenicity can have severe consequences for patients, this is why understanding the potential immunogenicity and immunotoxicity of you...

Noel Smith, Ph.D., Head of Immunology at Lonza recently presented the webinar The good, the bad, and the ugly: How does identifying and mitigating potential for immunogenicity and immunotoxicity de-risk and accelerate your drug development? In it, Dr. Smi...

An understanding of the potential immunogenicity risk of your therapeutic candidate is a key part of pre-clinical development. While human primary cell assays can provide vital data to help support this assessment, the design and qualification of such hum...

In this webinar, we explore the challenges of assessing the immunosafety profile when moving a drug candidate to first-in-human studies. Our expert shares key considerations and pitfalls to avoid along the way. Case studies highlight how in vitro&nbs...

Harnessing the power of the immune system has revolutionised treatment options for patients. However there are concerns about unwanted immune responses leading to serious adverse events.  Regulatory agencies require an assessment of a biotherapeutic&...