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Category: News

FDA Accepts Integral Molecular’s Membrane Proteome Array™ Qualification Plan, Advancing the Platform for Approval as a Drug Development Tool

Philadelphia – Integral Molecular, a leader in antibody discovery technologies, is proud to announce that the FDA has accepted their Membrane Proteome Array™ (MPA) Qualification Plan for advancement as a Drug Development Tool (DDT) to assess antibody binding specificity. Antibody drug developers already routinely include MPA data in regulatory packages, and qualification as a DDT will allow them to further rely on the MPA in the approval process. Integral Molecular’s MPA is the industry-leading technology for antibody specificity testing and is the only specificity platform under FDA consideration as a DDT.

Learn more about the Membrane Proteome Array™, and how it enables the precise identification of off-target binding interactions

Non-specific drug binding is a significant cause of adverse events in patients that can lead to severe complications or even death, and early specificity testing can de-risk drug development and enhance patient safety. Recent research has demonstrated that up to one-third of antibody drugs exhibit non-specific binding to unintended targets.

The MPA assesses binding across ~6,000 structurally intact membrane proteins and is the only platform of its kind that screens membrane proteins in their native conformation. The MPA has been used to screen over 2,000 preclinical antibody therapeutics for customers worldwide, and MPA specificity data has been accepted by regulatory bodies globally, including the FDA, EMA, and NMPA.

“This milestone towards MPA qualification reflects the continued dedication of our team to set a new standard in testing antibody drug specificity. Our continued improvements to the MPA—including statistical analyses, bioinformatic comparisons, and enhanced quality systems—have been critical to our qualification plan and have supported ISO 9001 certification of our processes. We thank the FDA for their confidence in our approach and commitment to advancing the safety of biologics.”

-Benjamin Doranz, CEO, Integral Molecular

The MPA is progressing toward DDT qualification under the FDA’s ISTAND Pilot Program, which promotes Innovative Science and Technology Approaches for New Drugs. As part of this process, Integral Molecular has been invited to submit a Full Qualification Plan (FQP) for the MPA, which is the final step in achieving DDT status.

About Integral Molecular
Integral Molecular (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 membrane proteins, viruses, and antibodies, 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 cancer, diabetes, autoimmune disorders, and viral threats such as SARS-CoV-2, Ebola, Zika, and dengue viruses.

Follow Integral Molecular on LinkedIn

Press Contact:
Integral Molecular, Inc.
Soma Banik, PhD, Director of Public Relations
215-966-6061
info@integralmolecular.com
www.integralmolecular.com

Webinar Presented by Integral Molecular and The Antibody Society – How Specific are Antibody Drugs? Revealing insights from a new generation of specificity assays

Thursday, February 27, 2025
8 am PT, 10 am CT, 11 am ET
View the recording

Limitations of conventional specificity tools have contributed to undetected polyspecificity in antibody drugs. We performed a systematic specificity analysis of preclinical and clinical antibodies and identified a surprisingly high rate of off-target binding throughout the industry, with up to one third of antibody drugs displaying off-target binding. Our findings across different phases of drug development suggest polyspecificity is a major source of drug attrition, and better tools could help to improve drug approvals and patient safety.

In this webinar, we will discuss the emergence of cell-based protein arrays as an alternative and improved technology to evaluate antibody specificity.

Key takeaways:

  • Cell-based protein arrays, including Integral Molecular’s Membrane Proteome Array™ (MPA), enable precise assessment of binding interactions
  • The MPA identified off-target binding interactions that were missed in tissue cross-reactivity studies
  • Early detection of off-target antibody binding can mitigate drug toxicity and attrition

Antibody Society and Integral Molecular webinar

View the recording

Integral Molecular Recognized as an Employer of Choice by the City of Philadelphia
Employer of Choice 2025 Recognition Breakfast Photo credit: Dominique Nichole

Philadelphia –Integral Molecular, a leading biotechnology company in Philadelphia, is honored to announce its recognition as an Employer of Choice by the City of Philadelphia’s Department of Commerce, Office of Workforce Solutions, in conjunction with the Workforce Professional Alliance. The Employer of Choice Initiative recognizes Philadelphia’s impact-driven employers who are invested in recruitment, retention, and promotion practices that help close the skills gap. Integral Molecular was selected for this honor in recognition of its commitment to cultivating a skilled and diverse workforce, engagement with the local community, and leadership in the thriving Philadelphia biotech sector.

See news release from the City of Philadelphia

“We are thrilled and honored to be recognized by the City of Philadelphia as an Employer of Choice. Philadelphia has been our home for over 20 years. As we continue to grow, we are committed to nurturing local talent and building an inclusive, vibrant workplace where innovation thrives.”

-Sharon Willis, PhD, Co-founder of Integral Molecular

Integral Molecular’s success is driven by a commitment to its people and its workforce development strategies, including:

  • Employee Development and a People First Culture: Integral Molecular’s success is built on a foundation of prioritizing people. Embedded in the company’s culture is a supportive work environment where individual and team successes are celebrated.
  • Community Partnerships: Integral Molecular collaborates with local universities, community colleges, and workforce development programs to recruit and nurture local talent. It is proud to partner with organizations including West Philadelphia Skills Initiative, Community College of Philadelphia, and Wistar Institute’s Biomedical Technician Training Program. Integral Molecular is also committed to inspiring future scientists through its outreach initiatives. The company has partnered with programs including FirstHand and eCLOSE STEM education initiatives for Philadelphia public school students.
  • Biotechnology Leadership: Launched in 2001, Integral Molecular is a founding member of Philadelphia’s biotech hub and is dedicated to driving growth and innovation in this sector. The company is also a founding member of the Keystone LifeSciences Collaborative, whose mission is to support the life sciences industry in the region.

About Integral Molecular
Integral Molecular (integralmolecular.com) is the industry leader in creating and commercializing transformative technologies that advance the discovery of therapeutics against difficult protein targets. With 20+ years of experience focused on membrane proteins, viruses, and antibodies, 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 cancer, diabetes, autoimmune disorders, and viral threats such as SARS-CoV-2, Ebola, Zika, and dengue viruses.

Follow Integral Molecular on LinkedIn

Press Contact
Integral Molecular, Inc.
Soma Banik, PhD, Director of Public Relations
215-966-6061
info@integralmolecular.com
www.integralmolecular.com

Integral Molecular Awarded $2.7 Million to Advance the Membrane Proteome Array™ Towards FDA-Qualification as a Drug Development Tool

Integral Molecular, a leader in antibody discovery and characterization, has been awarded $2.7 million by the NIH Commercialization Readiness Pilot (CRP) Program. This funding will support FDA-qualification of Integral Molecular’s Membrane Proteome Array™ (MPA), a next-generation technology that provides critical safety data required for Investigational New Drug (IND) filings of biologic drugs. The MPA is a cell-based protein array designed for specificity testing of antibody-based therapeutics and the only platform that screens for specificity using native protein conformations.

Learn how the Membrane Proteome Array™ enables the precise identification of off-target binding interactions, a primary determinant of drug safety

Integral Molecular’s recently published data show that up to one-third of antibody drugs have non-specific binding, and suggests that off-target binding is a significant cause of drug failure (Norden et al., 2024). Non-specific binding was detected even for drugs currently on the market that were previously screened using tissue cross-reactivity (TCR), an older and less precise technology. The new NIH funding will support efforts to validate the MPA as a more accurate alternative to TCR.

“We thank the NIH for their ongoing commitment to advancing drug safety tools. Their continued support—from early-stage grants to this advanced-stage CRP award—has been essential in making our Membrane Proteome Array the industry standard for in vitro specificity testing of biologics.”

– Benjamin Doranz, CEO, Integral Molecular

MPA processes are ISO 9001 certified, and the technology is under FDA review for qualification as a Drug Development Tool (DDT). Once qualified within its context-of-use, DDTs can be relied upon in IND, NDA, or BLA applications without needing the FDA to reconsider and reconfirm their suitability. The newly awarded CRP funds will support the company’s ISO 9001 commitment to quality assurance, continuous process improvement, and the MPA’s pathway to qualification.

About Integral Molecular
Integral Molecular (integralmolecular.com) is the industry leader in creating and commercializing transformative technologies that advance the discovery of therapeutics against difficult protein targets. With 20+ years of experience focused on membrane proteins, viruses, and antibodies, 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 cancer, diabetes, autoimmune disorders, and viral threats such as SARS-CoV-2, Ebola, Zika, and dengue viruses.

Follow Integral Molecular on LinkedIn

Press Contact
Integral Molecular, Inc.
Soma Banik, PhD, Director of Public Relations
215-966-6061
info@integralmolecular.com
www.integralmolecular.com

Integral Molecular Secures $8 Million NIAID Contract to Combat Emerging Viruses

Philadelphia– Integral Molecular, a leader in developing advanced technologies for the discovery of vaccines and therapeutics, is excited to announce a five-year, $8 million contract from the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID). This funding will support the company’s ongoing research into emerging viruses identified as pandemic threats—the fourth such contract awarded to the company in 15 years. Prior contracts enabled responses to recent virus outbreaks, including SARS-CoV-2, Zika, Ebola, dengue, and chikungunya.

Integral Molecular will use its high-throughput mapping platform to identify antibody binding sites (“epitopes”) on viruses, characterizing immune responses to viral threats—information that helps scientists design effective vaccines. The company’s innovative Reporter Virus Particles (RVPs) will also play a key role in this research. These non-replicative virus particles enable safe and high-throughput neutralization studies of highly pathogenic viruses using only standard laboratory facilities. RVPs are enabling researchers worldwide to rapidly develop vaccines and therapeutics against viruses such as SARS-CoV-2, Ebola, dengue, and influenza, and are featured in over 200 peer-reviewed papers.

Learn how Integral Molecular’s Epitope Mapping and RVP offerings enable vaccine research

The NIAID contract allows Integral Molecular to expand its research on potential pandemic threats to include Rift Valley Fever, Crimean-Congo Hemorrhagic Fever, and Enterovirus D68 viruses. Through previous contracts, researchers at Integral Molecular identified over 900 epitopes that characterize the human immune response to these viruses, and many are described in leading peer-reviewed journals including Cell, Science, and Nature.

“We are grateful to NIAID for their continued support and trust in our capabilities,” said Benjamin Doranz, CEO of Integral Molecular. “Viral threats can emerge quickly and with little warning. This contract enables us to contribute to pandemic preparedness by focusing on understudied viruses identified as potential threats, using our technologies to make virology research more accessible to laboratories around the world.”

This project is funded by NIAID/NIH under Contract 75N93024C00071.

About Integral Molecular
Integral Molecular (integralmolecular.com) is the industry leader in creating and commercializing transformative technologies that advance the discovery of therapeutics against difficult protein targets. With 20+ years of experience focused on membrane proteins, viruses, and antibodies, 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 cancer, diabetes, autoimmune disorders, and viral threats such as SARS-CoV-2, Ebola, Zika, and dengue viruses.

Follow Integral Molecular on LinkedIn

Press Contact
Integral Molecular, Inc.
Soma Banik, PhD, Director of Public Relations
215-966-6061
info@integralmolecular.com
www.integralmolecular.com

Up to One-Third of Antibody Drugs Are Nonspecific, Study Shows

Integral Molecular’s Membrane Proteome Array™ Reveals Pervasive Binding of Antibody-Based Drugs to Unintended Targets

An Integral Molecular scientist screens antibody drugs for specificity using the Membrane Proteome Array™, a high-throughput, cell-based, protein array technology. Photo credit: CreativeOutfit

Philadelphia– Integral Molecular, a leader in antibody discovery and characterization, has published new research in the journal mAbs, revealing that as many as one-third of antibody-based drugs exhibit nonspecific binding to unintended targets. A serious concern, off-target drug binding is a significant cause of adverse events in patients, with the potential to even cause death. Analysis of antibody off-target binding across different phases of clinical development suggests this to be a major cause of drug attrition. Early specificity testing could improve drug approvals and patient safety.

Learn how antibody developers can use the Membrane Proteome Array™ to assess specificity and de-risk drug development

In this study, Norden et al. present the first empirical assessment of antibody specificity, quantifying the prevalence of off-target binding across the drug pipeline. They accomplished this through retrospective specificity analyses of leading antibody candidates from biopharmaceutical companies and a prospective study of clinically administered antibody drugs (including those that are given to patients in advanced clinical trials, FDA-approved, or withdrawn). The molecules were tested using the Membrane Proteome Array™ (MPA), a cell-based protein array representing the human membrane proteome, that was developed to test specificity and improve drug safety.

Key Findings (Norden et al., mAbs)

  • 18% of the 83 clinically administered antibody drugs tested showed off-target interactions.
  • 22% of the antibody drugs withdrawn from the market, often due to safety issues, showed nonspecific binding.
  • 33% of the 254 lead molecules tested showed nonspecific binding, a predictor of failure in future stages of development.

These findings challenge the long-held belief in the absolute specificity of antibodies and underscore the critical need for more rigorous testing.

“Nonspecific drug binding can lead to adverse events or even death” said Diana Norden, PhD, lead study author. “The presumption that every antibody confers absolute specificity is simply not accurate. New technologies like the MPA provide a detailed assessment of antibody specificity and can significantly de-risk drug development.”

About the Membrane Proteome Array™
Integral Molecular’s Membrane Proteome Array™ is the industry-leading technology for antibody specificity testing used by hundreds of customers worldwide. The MPA assesses binding across ~6,000 proteins, representing the full human membrane proteome. Each protein within the array is individually presented in its biological conformation. MPA processes are ISO 9001 certified, and its specificity data has been accepted by regulatory bodies globally, including the FDA. The MPA is currently under review by the FDA for qualification as an accepted Drug Development Tool.

About Integral Molecular
Integral Molecular (integralmolecular.com) is the industry leader in creating and commercializing transformative technologies that advance the discovery of therapeutics against difficult protein targets. With 20+ years of experience focused on membrane proteins, viruses, and antibodies, 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 cancer, diabetes, autoimmune disorders, and viral threats such as SARS-CoV-2, Ebola, Zika, and dengue viruses.

Follow Integral Molecular on LinkedIn

Press Contact
Integral Molecular, Inc.
Soma Banik, PhD, Director of Public Relations
215-966-6061
info@integralmolecular.com
www.integralmolecular.com

Integral Molecular Achieves ISO 9001 Certification for its Virology Critical Reagents Supporting Vaccine Development

Philadelphia– Integral Molecular, a leader in providing essential research tools that enable vaccine development, proudly announces the achievement of ISO 9001 certification for the quality systems and processes used in their virology offerings. With over 20 years of experience and 100+ peer-reviewed publications in virology, Integral Molecular is a trusted partner for researchers and pharmaceutical companies worldwide, supplying critical reagents such as Reporter Virus Particles (RVPs), virus-like particles (VLPs), pseudoviruses, and Influenza TiterSafe™ VLPs. These non-replicative particles provide a ready-to-use substitute for live viruses and have been used in neutralization assays to support the clinical development of marketed vaccines.

Explore Integral Molecular’s Virology Offerings

ISO 9001 certification underscores Integral Molecular’s commitment to maintaining the highest standards for quality.

High Quality Virology Tools Enable:

  • Reproducible data. Quality-controlled processes and stringent lot-release criteria ensure product uniformity and reliable experimental results with minimized variability.
  • High-throughput assays for clinical trials. RVPs are critical reagents that can be confidently included in submissions to regulatory agencies such as the FDA or EMA to support approval for new vaccines and drugs.
  • Scale-up for large studies. Scalable processes enable end-users to seamlessly request large volumes of critical reagent material to test the hundreds to thousands of samples necessary for all phases of clinical trial testing of serum samples.

“The FDA has recognized the value of using non-replicative virus reagents to obtain immunogenicity data for vaccine studies—especially during the COVID pandemic, when the ability to conduct rapid serum neutralization studies was paramount. Our virology reagents are manufactured using standardized procedures and ISO-certified processes. Scientists can trust the consistency and reliability of our products, knowing exactly what to expect each time.”   
—Maya Cabot, PhD, Senior Product Manager, Integral Molecular

About Integral Molecular
Integral Molecular (integralmolecular.com) is the industry leader in creating and commercializing transformative technologies that advance the discovery of therapeutics against difficult protein targets. With 20+ years of experience focused on membrane proteins, viruses, and antibodies, 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 cancer, diabetes, autoimmune disorders, and viral threats such as SARS-CoV-2, Ebola, Zika, and dengue viruses.

Follow Integral Molecular on LinkedIn

Press Contact
Integral Molecular, Inc.
Soma Banik, PhD, Director of Public Relations
215-966-6061
info@integralmolecular.com
www.integralmolecular.com

Antibody Startup Emerges from Stealth: Cell Surface Bio Set to Transform the $10B Antibody Reagent Market

Company debuts catalog of validated, recombinant, specific antibodies against difficult protein targets, providing only the highest quality reagents for life sciences research

A scientist at Cell Surface Bio describing confocal immunofluorescence data obtained using a CSB antibody.

Philadelphia – Emerging from stealth mode today, Cell Surface Bio (CSB) launches VeRSaMAb research antibodies with the vision of delivering “antibodies that always work,” answering the call of the scientific community for reliable reagents with uncompromising quality. Providing monoclonal antibodies that are extensively validated, recombinantly cloned, and exquisitely specific, CSB is being built to transform the >$10 billion antibody reagent market where currently half of the antibodies sold do not work as designed.

View Cell Surface Bio’s mission and the VeRSaMAb catalog

Validated Antibodies with Unparalleled Specificity

VeRSaMAbs are produced at CSB and extensively characterized to ensure reliable results in customers’ experiments every time. Now available for purchase, VeRSaMAbs are:

  • Validated for flow cytometry, immunofluorescence, and other applications
  • Recombinantly cloned for batch-to-batch consistency, enhanced detection, and reproducible results
  • Specific for only the target of interest as assessed across 6,000 native proteins of the Membrane Proteome Array™

Transforming Life Science Reagents

“Cell Surface Bio was created by scientists for scientists,” explained Benjamin Doranz, PhD, Co-founder of Cell Surface Bio. “Every researcher I’ve met, myself included, knows the frustration of time wasted in the lab running experiments with antibodies that simply do not work. Our goal is to provide researchers with only the highest quality monoclonal antibodies that are fully validated and engineered for the highest sensitivity of detection, so that they always work in our customers’ experiments.”

A spin-out of Philadelphia’s Integral Molecular, CSB leverages the parent company’s 20+ years of expertise developing and characterizing therapeutic antibodies that target complex and conserved proteins on the cell surface. CSB’s VeRSaMAbs are derived using the same next-generation platform used to isolate best-in-class drugs, featuring high-throughput mRNA immunization, Lipoparticles™ (virus-like particles) for high-concentration presentation of structurally intact membrane proteins, divergent species (chickens) to generate antibodies against conserved epitopes, and optimized protocols for the isolation of rare antibodies, even for membrane proteins embedded in a lipid bilayer.

VeRSaMAbs are available for a wide range of protein targets across scientific fields, including immunology, oncology, and virology, and CSB’s catalog will continue to expand as MAbs are validated. Visit CSB to suggest new antibodies to add to the catalog!

About Cell Surface Bio
Cell Surface Bio’s mission is to provide researchers with only the highest quality antibodies, because as fellow scientists, we know that your time in the lab is valuable. CSB’s VeRSaMAb antibodies are built on 20+ of expertise in discovering and characterizing antibodies against the most difficult cell surface proteins. VeRSaMAbs are Validated, Recombinant, and Specific to ensure reliable results every time.

Press Contact:
Soma Banik, PhD, Director of Public Relations
Cell Surface Bio
215-987-0728
cellsurfacebio.com

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Webinar Presented by Integral Molecular and Fierce Biotech – Redefining Antibody Specificity Profiling for IND

Thursday, June 6, 2024
8 am PT, 11 am ET, 17:00 CET
View the recording

Assessment of antibody off-target reactivity is a regulatory requirement for clinical development. However, conventional screening methods, such as tissue cross-reactivity studies, are often ineffective in screening newer therapeutic modalities, and their predictive value for in vivo safety and toxicity is poor. So, what are the alternatives?

Join our webinar to learn about the new, innovative cell-based protein array approach to specificity profiling. We’ll take a deep dive into the Membrane Proteome Array (MPA), a 6,000-protein array platform that tests binding of biotherapeutics across the full human membrane proteome expressed in unfixed cells.

Attendees will learn how:

  • Integral Molecular’s MPA is used to rapidly and accurately identify potential off-target binding liabilities
  • MPA data support both lead selection and IND submissions with advantages over tissue cross-reactivity studies
  • Cell protein arrays, like the MPA, are rapidly progressing towards FDA endorsement through inclusion in CAR-T development guidelines and qualification as an antibody Drug Development Tool
 Integral Molecular and Fierce webinar 2024

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