The Good, The Bad, And The Ugly:How Does Identifying And Mitigating Potential For Immunogenicity And Immunotoxicity De-Risk And Accelerate Your Drug Development?

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【Summary】

The immune system is a potent, flexible, and programmable ally in the fight against some of the most life-threatening clinical challenges. With the field’s current pace, immune-based therapy has become a mainstay of clinical practice, with results that were unimaginable a couple decades ago.

There is huge promise in harnessing the immune system, but misdirecting this powerful response can have serious and even life-threatening consequences for your patients. An understanding of the potential immunogenicity and immunotoxicity of your candidate/s is a regulatory requirement to support your first-in-human (FIH) program and an area where, unfortunately, “standard” in vivo toxicology assessments might lack relevance. As a result, the onus is on you, the biopharmaceutical developer, to ensure you have adequately assessed the possibility of your drug candidate/s to illicit an unwanted immune response.

In this webinar, we explore the challenges of assessing the immunosafety profile when moving a drug candidate to FIH studies. Our expert shares key considerations and pitfalls to avoid along the way. Case studies highlight how in vitro immunotoxicity assessments add significant value by predicting risk early. This knowledge allows for modifications to the candidate or FIH package design to mitigate risk and increase the likelihood of a successful FIH study.

As one of the world’s most renowned companies for contract development and manufacturing, Lonza Pharma & Biotech is recognized for our reliable, high-quality services, our global capacity, our innovative technology platforms, and our extensive experience. From 2013 to 2016, our contributions supported 36% of launches with small-molecule breakthrough designation. In 2016 alone, we provided manufacturing services for more than 50 commercial molecules and conducted more than 250 development programs. We have helped launch pioneering autologous cell therapies.

Success for us is when you, as our partner, are fully satisfied. We continuously improve and innovate to meet your expectations and improve your chances of business success. Our broad capabilities span across biologics, small molecules, bioconjugates, and cell and gene therapies. We manage projects from pre-clinical stage through to commercialization, and our expertise covers both drug substance and drug product.

We believe that the best outcome – for you and for your patients – can only come as a result of a successful collaboration. Together, we can solve the next challenge and bring your next medicine to life.