Biomarker and immunogenicity testing: an interview with Jayaprakash Kotha
In this interview, Jayaprakash Kotha (Vice President, Bioanalytical Laboratory at Worldwide Clinical Trials, NC, USA) discusses the significant advantages of why biopharma outsource bioanalytical work to CROs as they have skilled scientists, advanced laboratories as well as expertise in study and data management. He covers the difference between GCLP and GLP and why biomarker testing in drug development is so important.
Kotha comments on how over the past 20 years there has been an increase in protein therapeutics, such as biologics, and how proteins are highly immunogenic. He concludes by discussing the two main immunogenicity assessments for large molecule bioanalysis, ADA and NAb testing, and how multiplex analysis is now commonplace.
Questions discussed:
- What are the benefits of outsourcing bioanalytical work to CROs?
- What is the difference between GCLP and GLP guidelines?
- What is the significance of biomarker testing in drug development?
- What is immunogenicity testing and what laboratory assays can be used to test immunogenicity?
- What is multiplex analysis in biomarker testing?
In association with
