In this issue, learn about the validation of immunogenicity assays to support nonclinical and clinical studies, including different purposes and challenges.

Click here to download a PDF, readable version of Issue 20: https://www.altasciences.com/sites/default/files/2021-11/The-Altascientist_issue-20_Immunogenicity-Assays.pdf

Regulatory guidelines focusing on immunogenicity assays for clinical studies are not all applicable to nonclinical requirements and their unique challenges. While we have a full understanding of regulatory requirements for clinical studies, the lack of regulatory documents addressing the particular needs of nonclinical immunogenicity studies has contributed to less consensus on appropriate immunogenicity testing strategies and validation parameters. This, by extension, has led to different approaches being adopted by the drug development industry.

CHPATERS:

- 0:00 — Section 1: Introduction

- 1:04 — Section 2: Challenges and Goals

- 3:31 — Section 3: Validation of Immunogenicity Assays for Nonclinical Studies

- 10:45 — Section 4: Validation of Immunogenicity Assays for Clinical Studies

- 20:42 — Section 5: Conclusion

About Altasciences:

Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.