Lipid nanoparticles: immunogenicity assessment, challenges and regulations with Uma Kavita

In this interview, Uma Kavita, Principal Scientist, Bristol-Myers Squibb (NJ, USA) discusses the bioanalysis of lipid nanoparticle drug products. Kavita explores the importance of conducting immunogenicity assessments as well as explaining the relevant regulatory guidelines and some of the challenges with these.

Q What are lipid nanoparticle drug products? How are they given and how do they work?

Q Why is it important to conduct immunogenicity assessments?

Q What are the challenges of assessing immunogenicity?

Q Could you explain relevant regulatory guidelines – are there any challenges with these?