Nano and Biomaterials, Manufacturing and Quality Control

The Nanomedicine Manufacturing Laboratory (NML) at Duquesne University, supported by multiple federal awards, develops and scales advanced nano- and biomaterial platforms for therapeutic delivery, multimodal imaging, and oxygen transport applications. The laboratory integrates materials science, pharmacology, and bioengineering to engineer reproducible, sterile formulations that meet rigorous quality and safety standards for both in vitro and in vivo studies.

The Nanomedicine Manufacturing Laboratory operates under implemented Quality-by-Design (QbD) principles, embedding controlled manufacturing workflows and predefined release specifications into every project. Each formulation undergoes comprehensive physicochemical and biological characterization—including stability, performance, and safety assessments—prior to distribution to collaborating institutions for translational evaluation. This integrated manufacturing-to-validation framework enables the development of targeted pain nanomedicines; oxygen-carrying nanoplatforms tailored for human tissue and organ machine-supported preservation; and multifunctional imaging agents for immune cell tracking across diverse disease and injury models.

Through sustained partnerships with federal agencies, industry collaborators, and national and international academic institutions, the Nanomedicine Manufacturing Laboratory advances innovation at the interface of nanotechnology, therapeutics, and regenerative medicine.

Research Areas

Nanomedicine Manufacturing Laboratory (NML) is a materials-focused research and manufacturing laboratory specializing in the sterile production of nanomaterials and biomaterials for imaging, drug delivery, and oxygen delivery. The Nanomedicine Manufacturing Laboratory manufactures nanoemulsions, microemulsions, micelles, colloidal dispersions, solid lipid nanoparticles, and hydrogel-based biomaterials, with routine production at the liter scale using controlled, reproducible processes.

All materials are produced under defined manufacturing workflows with embedded Quality-by-Design (QbD) principles. The Nanomedicine Manufacturing Laboratory conducts in-house material characterizations, pharmacological testing, and quality control, including batch-release testing prior to delivery to collaborating laboratories across the USA and abroad. Products are manufactured as sterile formulations when required and prepared for local, parenteral, or implantable use depending on the application.

The Nanomedicine Manufacturing Laboratory maintains a comprehensive product-tracking and quality-monitoring systems for all nanomedicine and biomaterial products developed under collaborative projects. Each product is uniquely coded, documented, tested, and released to collaborating laboratories only after a Certificate of Analysis (CoA) is issued. All collaborating sites are required to execute a Material Request Form, enabling continued quality control monitoring across the full product lifecycle—from manufacture through study completion and post-use assessment.

The Nanomedicine Manufacturing Laboratory products are rigorously evaluated for safety, performance, and reproducibility across multiple preclinical models and collaborative programs. This work is supported by the U.S. Air Force, Congressionally Directed Medical Research Programs, National Institutes of Health, and ARPA-H, and involves partners across academia, industry, and government.
This image depicts the Nanomedicine Manufacturing Lab’s scalable production and quality control capabilities. A young woman stands beside manufacturing equipment with bottles of green liquid, a large-scale nanoemulsion product produced at 2 L, alongside graphs representing data analysis and monitoring. Highlighted functions include batch coding and tracking, stability and degradation testing, drug content and release analysis (HPLC/LCMS), sterility testing (USP-guided), predictive storage modeling, lyophilization, and sterile filling for large-scale batches. These manufacturing processes support reproducible drug delivery and translation to preclinical and clinical applications.
NML has also been a full MTEC Member since 2023.

Pain nanomedicine at the Nanomedicine Manufacturing Laboratory is an innovative, non-opioid analgesic platform designed to support injury-specific targeted neuroimmunomodulation, neuroregeneration, and neuromuscular recovery. The platform achieves targeted, sustained modulation of neuroimmune interactions at the site of injury while minimizing systemic exposure and avoiding side effects in the central nervous system, gastrointestinal tract, and cardiovascular system. Non-invasive imaging is used to monitor the localization and persistence of nanomedicine at the target site over time, enabling correlation between biodistribution and functional outcomes, including neuromuscular recovery and prolonged analgesia. To date, pain nanomedicine has been evaluated in numerous preclinical models. Through partnerships with collaborating laboratories in neuroscience, pain biology, and reconstructive surgery, pain nanomedicine has also contributed to the discovery of new mechanisms in pain biology. Theranostic pain nanomedicine has been successfully used as a nanoimaging probe to investigate pain mechanisms, particularly the roles of immune cells. At Duquesne University, John A. Pollock, Professor of Neuroscience, and his lab have used this platform to establish the role of immune cells in acute and chronic neuropathic pain and to elucidate sex differences in pain biology.

This image illustrates the therapeutic and diagnostic mechanism of a theranostic nanoemulsion (CUR-NE) in a Complete Freund’s Adjuvant (CFA) rat model of inflammation. Representative diagrams of the nanoparticle, the macrophages carrying nanoparticles in bloodstream, the change from M1 to M2 macrophage polarity and histological analysis of macrophage infiltration at the inflamed site are shown.

Image reproduced from: J Nanobiotechnol 23, 80 (2025). https://doi.org/10.1186/s12951-025-03164-w

Funding:

  • W81XWH-20-1-0854: Long-Acting Non-Opioid Analgesic (LANA) Nanomedicine for Rapid, Single Dose, Sustained Pain Control and Rehabilitation Support After Neuromusculoskeletal Injury)
  • AFMSA FA8650-17-2-6836: A Targeted, Local, Non-Opioid Therapeutic Strategy for Mitigation, Modulation, and Management of Trauma Induced Neuropathic Pain
  • NIH NIDA R21 DA039621-01: Theranostic Pain Nanomedicines: imaging inflammation, reducing pain and need for opioids
  • W81XWH-20-1-0276: Neuro-Immuno Modulating Analgesic (NIMA) Nanomedicine Platform for Treatment of Diabetic Neuropathy

Patents filed in 2025.

Oxygen-delivery materials developed at the Nanomedicine Manufacturing Laboratory are based on perfluorocarbon nanoemulsions (PFC-NEs), which function as biocompatible, acellular oxygen carriers with high oxygen solubility and chemical and metabolic inertness. Unlike hemoglobin-based systems, oxygen delivery from perfluorocarbons is directly governed by local oxygen partial pressure, enabling controlled delivery to hypoxic tissues. The Nanomedicine Manufacturing Laboratory has developed stable, nanoscale perfluorocarbon formulations that support oxygen delivery, alone or in combination with therapeutic and imaging components, enabling extended (> 48h) metabolic support and organ viability, and enabling real-time, non-invasive imaging of perfusate flow during machine perfusion. For applications including machine-based tissue, limb, and solid-organ preservation, these materials are engineered to access distal microvasculature, maintain stability during extended perfusion, and enable non-invasive tracking of perfusate distribution.

This image details the application of a perfluorocarbon nanoemulsion (PFC-NE) designed for dual drug and oxygen delivery during ex vivo machine perfusion to enhance organ transplantation outcomes. A NIRF Labeled PFC NE for Dual Drug Delivery Capabilities and Oxygen Delivery is shown via a schematic, as well as to how it transfers within the bloodstream. Once in the bloodstream, the Reactive Oxygen Species and Lipid Peroxidation amount decreases. NIRF Imaging of the perfluorocarbon nanoemulsions during ex vivo machine perfusion improved organ viability and prevented ferroptosis induced ischemic reperfusion injury, with the lungs, heart, kidney, and liver shown as representative organ pictures.

Image reproduced from Pharmaceutics 2026, 18, 143. https://doi.org/10.3390/pharmaceutics18020143

Funding:

  • FA8650-20-2-6224: Semi-Autonomous Battlefield Resuscitation and Evacuation/Nano-Emulsion Oxygen Carrier for Advanced Resuscitation and Evacuation (NEOCARE)
  • HT9425-24-1-0828: Resuscitation by Endothelial Stabilization and Targeted Oxygen Rescue (RESTOR) Platform for Vascularized Composite Allotransplantation

Patents filed in 2024.

Nanoimaging agents developed at the Nanomedicine Manufacturing Laboratory enable non-invasive, longitudinal imaging of immune cells, with primary applications in neuroinflammation and transplant rejection. These materials function as multimodal imaging platforms, incorporating near-infrared fluorescence (NIRF) and magnetic resonance imaging (MRI) capabilities to support spatial and temporal tracking of immune cell distribution and dynamics in vivo. The Nanomedicine Manufacturing Laboratory nanoimaging agents support longitudinal immunomonitoring in translational models across species, enabling repeated, non-invasive assessment of immune cell infiltration, persistence, and spatial organization over time. The materials are sterile, safe, non-immunogenic, and stable in vivo for weeks to months, depending on biological context and study design. Nanoimaging agents are routinely manufactured at large scale (>1 L per batch) using controlled, reproducible processes to support multi-site collaborative studies.

This schematic illustrates the multi-stage pipeline for the development and validation of theranostic perfluorocarbon nanoemulsions (PFC-NEs) for inflammatory research. The process begins with in vitro quality testing of PFC-NEs, including a particle size distribution graph and multi-well plate fluorescence imaging at 700 nm and 800 nm to confirm stability and labeling efficiency. In the in vivo labeling stage, a syringe administers PFC-NEs composed of a perfluorocarbon core, therapeutic drug, and near infrared fluorescent dye into a mouse model with localized inflammation. Monocyte derived macrophages internalize the nanoemulsions, enabling cellular labeling and tracking. The final stage demonstrates diagnostic validation through near infrared fluorescence imaging in vivo, where a green signal identifies the inflammatory site in the living subject, and fluorescence microscopy ex vivo, where excised tissues are analyzed to confirm cellular level delivery and localization within the tissue.

Image reproduced from: Bio-protocol 13(19): e4842. DOI: 10.21769/BioProtoc.4842.

Funding:

  • W81XWH-20-1-730: Nanoimaging for Noninvasive Monitoring of Donor and Recipient Immune System Contribution to Acute and Chronic Rejection in VCA)
  • W81XWH-19-1-0828: A Novel Graft Implanted “Macrophage-Enzyme Responsive Immunosuppressive Therapy” (MERIT) to Prevent Chronic Rejection in Vascularized Composite Allotransplantation)
  • NIH NIBIB R21EB023104-01: Multimodal (PET/MR/NIR) imaging supported drug delivery in inflammatory diseases

The Nanomedicine Manufacturing Laboratory develops sterile nanosystem-loaded hydrogels as biocompatible and non-immunogenic biomaterial platforms for localized therapeutic delivery and immune modulation. These platforms include hydrogels loaded with nanosystems—for example nanoemulsions (nanoemulgels), microemulsions (microemulgels), and micelles (micelle-loaded hydrogels)—enabling localized, multi-payload presentation within a single formulation. These hydrogel platforms are thermoresponsive and injectable, allowing minimally invasive administration, and can be safely implanted into wounds or surgical sites where in situ gelation or stabilization supports sustained local activity. Sterile nanosystem-loaded hydrogels developed at the Nanomedicine Manufacturing Laboratory are designed for wound healing, local multi-drug delivery, and targeted modulation of immune cell activity at sites of injury or implantation.

This schematic illustrates the function of an injectable thermoresponsive nanoemulgel for localized treatment of inflammation and immunosuppression provision. The diagram shows a syringe delivering the nanoemulgel formulation into a subcutaneous site where it solidifies at a body temperature of 37 degrees Celsius. Individual nanoemulsion droplets are then released from the gel matrix and internalized by nearby macrophages. This cellular uptake results in a therapeutic response characterized by a reduction in pro-inflammatory markers, specifically IL-6, TNF-alpha, and NO2.

Image reproduced from Pharmaceutics 2023, 15, 2372. https://doi.org/10.3390/pharmaceutics15102372

Funding:

  • AFMSA FA8650-17-2-6836: A Targeted, Local, Non-Opioid Therapeutic Strategy for Mitigation, Modulation, and Management of Trauma Induced Neuropathic Pain
  • W81XWH-20-1-0276: Neuro-Immuno Modulating Analgesic (NIMA) Nanomedicine Platform for Treatment of Diabetic Neuropathy
  • W81XWH-20-1-0769: Novel Graft Implanted Macrophage Targeted Nanoemulgels for In Situ Immunosuppression in Vascularized Composite Allografts

Collaboration

Pollock Lab, Duquesne University

Shepherd Lab, MD Anderson Cancer Center

Gorantla Lab, Wake Forest University

Hitchens Lab, Advanced Imaging Center, University of Pittsburgh

  • Wake Forest School of Medicine
  • BMI Organ Bank
  • Stanford University
  • Harvard Medical School
  • Brigham and Women's Hospital
  • The University of Utah
  • Eversight
  • Functional Circulation
  • Moran Eye Center
  • The Metis Foundation
  • The University of Texas MD Anderson Cancer Center
  • University of Pittsburgh
  • Faron Pharmaceuticals
  • UT Health San Antonio Long School of Medicine
  • Joint Base San Antonio
  • Naval Medical Research Unit San Antonio
  • Carnegie Mellon University
  • TDA Research
  • inStem