Immunogenicity Data Delivered Without Delay
Preclinical Assays for Immunogenicity Testing in Clinical Trials
Whether developing a vaccine, biologic, or gene therapy, immunogenicity testing is required for regulatory approval and is critical for determining the safety and efficacy of your product.
Our scientific experts will ensure your nonclinical assays are adapted and validated for your clinical trials, with a tailored bioanalytical program designed for your drug type and study purpose. We focus on the right PK/PD endpoints to ensure regulatory and bioanalytical standards are met.
For more information on assessing immunogenicity, please browse and bookmark these resources.
A Comprehensive Guide to Immunomodulation
In this issue, find out more about the standard classes of immunomodulators, advanced bioanalytical methods, and case studies with practical insights.
Purposes and Challenges for Nonclinical and Clinical Studies
In this edition of The Altascientist, learn about the different purposes and challenges of validating immunogenicity assays to strategically develop a safe and quick approach to support nonclinical and clinical studies.
Challenges Encountered in Anti-Drug Antibody Assays
Find out how we have implemented strategies to overcome matrix interferences observed in disease populations. This allows us to assess immunogenicity in complex clinical studies targeting diverse populations, ensuring a comprehensive understanding of each therapeutic's impact.
Tailored Immunogenicity Testing Services
We cover all essential assays, from characterization to binding specificity, isotyping, and NAbs, while ensuring our approach is adapted to your drug's mechanism of action.
Ready to book your study or have a question about your study? Speak with one of our experts.