lmmunogenicity Testing
Avance Biosciences delivers expert immunogenicity testing to support preclinical and clinical ADA studies.
Our advanced platforms help you evaluate immune responses to biologics and meet regulatory requirements with confidence.
Immunogenicity testing is essential to determine if a biologic therapy elicits an immune response in the body. This response can impact drug safety and effectiveness, potentially leading to adverse reactions or therapeutic failure.
Are You Prepared?
FDA recommends adopting a risk-based approach to evaluating and managing immune responses to or immunologically related adverse clinical events associated with therapeutic protein products that affect their pharmacokinetics, pharmacodynamics, safety, and efficacy. Immunogenicity tests should be designed to detect ADA that could mediate unwanted biological or physiological consequences such as neutralizing activity or hypersensitivity responses.
Our Expertise
- Multi-tiered ADA testing
- Custom assay development
- GLP-compliant services
- Advanced immunoassay platforms
- Preclinical and clinical support
- Neutralizing antibody analysis
A Multi-tiered Testing Approach
- Screening Assay: Early detection of low- and high-affinity ADAs using sensitive methods, followed by confirmatory testing of reactive samples.
- Confirmatory Assay: Confirmatory assays verify specific ADA binding to the therapeutic protein, eliminate false positives from nonspecific binding, and enable further characterization through titration and neutralization assays.
- Titration Assay: ADA levels in positive samples are assessed by serial dilution, reporting the highest dilution factor where the sample remains positive.
- Neutralization Assay: Neutralizing antibodies (NAbs), a subset of ADAs that inhibit therapeutic activity, are assessed using assay types, cell-based or ligand-binding, selected based on the drug’s mechanism of action and target.
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Our Customers Say…
Your team met the timelines we needed and did exceptional technical work. I will definitely make my management aware that Avance is a very capable partner for our bioanalytical needs.
Bioanalytical Senior Project Manager, California
Avance Biosciences™ (AB) has delivered the Sequencing data in a record time. Very impressive! We have benefited from AB’s hard work and are very grateful for that. AB team should feel proud of themselves. We thank AB team for their support and contributions, much appreciated.Head of Quality Control, Microbial Manufacturing Service, California
My experience with Avance has been nothing but positive… I will keep sending work your way as I appreciate the attention your team provides and Avance’s creative technical team. See you soon.Director Individualized Medicines, California
Avance has been the ideal partner in helping Mission Bio and our client,… be the first in the world to GMP qualify our single cell % transduction assay for a lentiviral gene therapy product. Excellent execution on the part of the Avance team. We look forward to more collaborations in the future.
Senior Director, Cell & Gene Therapy Business, California
From the preliminary conclusion of this work, we are already pleased to thank you for your customer-oriented approach and proactive communication in the course of this study. We are happy to see the profound difference in business mindset between your organization and our previous vendor…
Project Manager, Belgium
Thank you so much for successfully completing this important project for us on time. We are very satisfied with the final report and thank you for taking the extra effort to customize the report format. We will definitely use your lab for future projects.
Program Manager, California
It has been a pleasure working with you and your team. The project was carried out to the highest standard and delivered in a timely manner. I will definitely recommend Avance Biosciences™’ services to colleagues and friends.
Senior Scientist, Singapore