In this issue, how to face bioanalytical challenges when evaluating the immunogenicity profile of protein-based therapeutic drugs, including:

• Challenges encountered in Anti-Drug Antibody (ADA) assays

• Information on when to use cell-based or non-cell-based assays to measure neutralization

Click here to download a PDF, readable version of Issue 8: https://www.altasciences.com/sites/default/files/2020-02/The%20Altascientist_issue8_ADAs_2020.pdf

CHAPTERS:

- 0:28-2:36 — Section 1: Introduction

- 2:36-5:08 — Section 2: Challenges Encountered in ADA Assays

- 5:08-6:32 — Section 3: How to Determine Cut-Point Evaluation for Oncology Clinical Studies

- 6:32-8:30 — Section 4: What to Do When the PEGylation of the Therapeutic Drug Masks Key Epitopes in the ADA Assay

- 8:30-12:08 — Section 5: Cell-Based or Non-Cell Based Assays to Measure Neutralization

- 12:08-13:45 — Section 6: Considerations for Choosing a Cell-Based Neutralizing Antibody Assay

- 13:45-14:46 — Section 7: Trusting Altasciences to Move Your Research Forward

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.