Webinar | September 27, 2016

Integrating Safety And Immunogenicity Assessments Into The Biopharma Preclinical Development Process

Source: Lonza Biologics, Inc.

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.

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. 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 vitroplatforms currently available at Lonza including case studies of projects that used the platforms.