Research Associate

Follow its DDT qualification journey. * March 13, 2026 * admin Welcome to Specificity Insights, its blog about current developments in antibody specificity testing! Over the coming months, Integral Molecular, Inc.'ll be releasing a multi-part series about specificity testing with the Membrane Proteome Array (MPA) and its 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 its regulatory-ready specificity testing service and an inside look at the ISTAND qualification process. Integral Molecular, Inc.'ll also share broader news about specificity testing and developments at Integral Molecular. What's this series about? In 2021, Integral Molecular, Inc. began working toward qualifying its 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 its technology, processes, and data, along with implementing their suggestions for enhancements. In late 2025, Integral Molecular, Inc. submitted its 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. Integral Molecular, Inc.'ll be breaking down much of that content through this blog series, providing detailed insights into the questions the FDA asked Integral Molecular, Inc. and its responses. In a few weeks, Integral Molecular, Inc.'ll also release an ebook with even more information. This document will be useful for anyone seeking details about its 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, Integral Molecular, Inc. 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 Integral Molecular, Inc. 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

10x faster virus neutralization testing with launch of Integral Molecular's Ready Reporter Virus(TM) kit. News provided by. PHILADELPHIA, Oct. 14, 2025 /PRNewswire/ - Integral Molecular, a leader in developing innovative tools for antiviral research, announces the launch of its Ready Reporter Virus(TM)(RRV) neutralization assay kit. This automation-compatible, safe assay assesses the effectiveness of vaccines and therapeutic antibodies and is set to transform how virus neutralization testing is performed. While conventional assays can take up to a week, the RRV kit delivers results in under 4 hours - 10 times faster than current standards. Learn more about RRVs, designed for high-throughput, automatable virus neutralization testing Conventional neutralization assays are labor intensive, requiring live pathogenic virus, specialized biosafety facilities, cultivation of cells under sterile conditions, and often manual counting of results. These barriers make testing impossible for most laboratories worldwide. In contrast, RRVs do not replicate or cause disease and do not require cell culture, making this assay accessible to all scientists. RRV kits come with thaw-and-mix reagents and use simple workflows ideal for automation, a key consideration for scientists who need to screen hundreds or even thousands of samples. Integral Molecular is the industry leader in providing viral particles to the vaccine industry, including its catalog of 100+ pseudotyped Reporter Virus Particles (RVPs) and Influenza TiterSafe(TM) Particles, a non-infectious alternative to the hemagglutination assay. RRVs expand this portfolio, giving scientists a powerful new way to perform rapid, safe virus neutralization experiments. RRVs are non-pathogenic, non-replicative virus-based particles that display authentic native viral proteins on their surface. Like live viruses, RRVs enter human cells through natural receptor interactions, providing biologically relevant neutralization data for therapeutic candidates. The RRV kit supplies live target cells preloaded with a dye that provides a quantitative readout immediately upon virus entry, so an end user just needs to thaw and mix the supplied reagents to assess virus infection. * Serum testing from humans or animals for vaccine-induced neutralization * Neutralization testing and lot-release for therapeutic antibodies * Public health applications including disease surveillance "Integral Molecular has long been committed to delivering safe, reliable tools that expand the ability of labs to conduct antiviral research critical for vaccine development," said Benjamin Doranz, PhD, CEO of Integral Molecular. "With RRVs, we are making neutralization testing not just faster, but also simpler, cost-effective, and more accessible for scientists who need robust, automatable assays without the burden of cell culture." RRV kits are currently available for viruses including influenza, SARS-CoV-2, and VSV. Kits are manufactured under ISO 9001-certified quality processes and can be customized for additional viruses or variants of interest. RRVs will be launched in a presentation by Christina Go, PhD, at the World Vaccine Congress this week in Amsterdam. About Integral Molecular Integral Molecular (virology.integralmolecular.com) is the industry leader in creating transformative technologies that advance the discovery of therapeutics against difficult protein targets. With 20+ years of experience focused on viruses, antibodies, and membrane proteins, Integral Molecular's technologies have been integrated into the drug discovery pipelines of over 600 biotech and pharmaceutical companies to help discover new therapies for viral threats such as SARS-CoV-2, Ebola, Zika, and dengue viruses, as well as chronic diseases such as cancer, diabetes, and autoimmune disorders. Follow Integral Molecular on LinkedIn Press Contact Integral Molecular Soma Banik, PhD, Director of Public Relations 215-966-6061 SOURCE Integral Molecular

PHILADELPHIA, May 21, 2025 /PRNewswire/ -- Integral Molecular, a founding member of Philadelphia's biotechnology hub, has been recognized as a 2025 Top Workplace by the Philadelphia Inquirer. This honor is based entirely on employee feedback and benchmarking against national standards, gathered through a confidential survey.See the full list of Top Workplaces named by the Philadelphia Inquirer"We are honored to be recognized as a 2025 Top Workplace in Philadelphia," said Sharon Willis, PhD, Co-founder of Integral Molecular. "This award reflects the collaborative and mission-driven culture we have built together, where people are supported to thrive in their career. Our company's growth is based on continuing to hire remarkable people."Integral Molecular's success is rooted in its commitment to people and its supportive culture.Employee Development and a People First Culture: A supportive work environment where individual and team accomplishments are celebrated.A supportive work environment where individual and team accomplishments are celebrated. Community Partnerships: Strong connections with local organizations for recruiting, training, and retaining homegrown talent.Strong connections with local organizations for recruiting, training, and retaining homegrown talent. Biotechnology Leadership: Active participation in regional initiatives such as the Keystone Life Sciences Collaborative, promoting the expansion of the Pennsylvania life sciences ecosystem.This recognition follows a year of notable achievements for the company