Efficacy, safety, immunogenicity and manufacturability issues play a large role in the high attrition rate of biopharmaceutical candidates each year. To help reduce the risk of failure, tools to address the developability of preclinical candidates have been established. These tools help to identify and optimize leads with the best chance of success at commercialization.
An important factor to consider when using risk assessment tools is timing. Immunogenicity is known to have a detrimental effect on both the efficacy and safety of a biopharmaceutical but is often not considered until clinical trials. Clinical failure can lead to termination of the entire program or necessitate re-engineering or alternative lead selection, significantly increasing costs and time to market. Integrating immunogenicity risk assessment into the early stages of development can significantly increase the chances of clinical success.
Lonza has developed a comprehensive set of preclinical safety and immunogenicity risk assessment tools to aid lead selection and characterization. This webinar will describe the in silico and in vitro platforms currently available at Lonza including case studies of projects that used the platforms. Topics to be covered include:
- Prediction of HLA bindingIdentification of naturally processed and presented
- HLA binding peptides
- Assessment of T cell responses
- Assessment of B cell responses
- Cytokine Release Assays
Click here to register for this free webinar scheduled for Wednesday, September 21, 2016 at 11:00 am EDT.