Welcome to Specificity Insights, our blog about current developments in antibody specificity testing! Over the coming months, we’ll be releasing a multi-part series about specificity testing with the Membrane Proteome Array (MPA) and our journey to qualify the MPA as a Drug Development Tool (DDT) through the FDA’s ISTAND program.
Through this series, you’ll gain access to detailed information about our regulatory-ready specificity testing service and an inside look at the ISTAND qualification process. We’ll also share broader news about specificity testing and developments at Integral Molecular.
What’s this Series About?
In 2021, we began working toward qualifying our MPA specificity testing platform as a DDT under the FDA’s ISTAND program. Qualification is a rigorous process. It has involved extensive discussions with the FDA about our technology, processes, and data, along with implementing their suggestions for enhancements. In late 2025, we submitted our Full Qualification Package (FQP), the final set of information the FDA needs to make their decision.
The FQP is a comprehensive document loaded with valuable information. While some details remain confidential—like trade secrets and project data—much of it can be shared. We’ll be breaking down much of that content through this blog series, providing detailed insights into the questions the FDA asked us and our responses.
In a few weeks, we’ll also release an ebook with even more information. This document will be useful for anyone seeking details about our specificity testing platform. And for those working toward qualifying their own DDT, it will provide insights into the FDA’s thinking.
Why Pursue FDA Qualification?
For anyone considering qualifying a tool through ISTAND, we highly recommend it. The experience has been invaluable. FDA review and input have transformed an already unmatched specificity testing platform into a tool that’s even more robust, reproducible, scalable, and well-documented.
To date, DDTs are under-utilized in drug development and rarely included in IND filings. To increase DDT adoption, the FDA is actively encouraging others to qualify their tools, and they are incentivizing drug developers to use these tools and include the resulting data in their regulatory submissions. DDTs, they believe, will help get better treatments to patients faster.
Looking Ahead: What’s Coming in This Series
This series will cover a broad range of topics, including:
→ Why current specificity testing methods fall short
→ What the FDA qualification process looks like from the inside
→ What we learned from screening 2,000+ biotherapeutics
→ The quality systems behind regulatory-grade testing
→ How to interpret and use specificity data for decision-making
…and much more