Content Library

Periods of planning and transition are a practical time to review how research materials and supporting records are managed across biorepository and archiving workflows. A quick look now can improve visibility, reduce storage complexity, and keep critical research assets ready for audits, transfers, or future study needs.

Avoid the seven most common tissue cross-reactivity planning mistakes, from late starts to unreliable methods, that can put your IND, CTA or first-in-human timeline at risk.

Expert guidance on classifying adverse vs. nonadverse nerve fiber degeneration in intrathecal oligonucleotide nonclinical toxicity studies.

Explore how early integration of toxicologic pathology can improve medical device safety, reduce miscommunication, and strengthen regulatory outcomes in device development.

Learn how integrating toxicologic pathology best practices into medical device evaluation can improve biological assessment, strengthen regulatory outcomes, and reduce study risk.

Pregnancy requires precise immune regulation. From ovulation to implantation, fetal development, and parturition, the maternal immune system undergoes dynamic changes to support the developing fetus while maintaining the health of the mother.

The road to bringing a medical device to market is fraught with potential regulatory pitfalls and decisions that can delay—or even derail—your efforts.

As part of the World Health Organization (WHO), the International Agency for Research on Cancer (IARC) works to identify potential carcinogenic hazards to humans.

Peripheral arterial disease (PAD) affects more than 200 million people worldwide, with its most severe manifestation, chronic limb-threatening ischemia, potentially leading to imminent limb loss in up to 11% of patients.

Intravitreal drug development is challenging, primarily due to the sensitivity of the eye and the limited safe injection volume.

Traditional diagnostic pathology relies on a narrowly scoped set of expertise and technologies to identify and diagnose diseases and determine treatment efficacy based on tissue examination.

Mass Spectrometry Imaging (MSI) measures in tissue sections at microscopic resolution the mass-to-charge ratio of ions via an analytical technique that makes the identification of different molecular species possible.

Exploratory pathology involves the comprehensive analysis and interpretation of tissue samples to understand the mechanisms of disease and disease pathogenesis (i.e., how a disease functions).

Pathologists face difficulty in accurately and consistently differentiating osteosarcoma (OSA) from other types of neoplasms using only histopathology.

Historically, success in pinpointing the microenvironmental contributions to soft tissue sarcoma progression, especially during the onset of sarcoma, has proven elusive.

StageBio clients often ask for expert guidance when it comes to developing a protocol for the pathology work of their medical device studies. Senior Pathologist Lynette Phillips, DVM, PhD, DACVP, held a live webinar event to demystify several preclinical pathology operations which are crucial to a study’s success.

StageBio Director of Digital and Quantitative Pathology Thomas Lemarchand, DMV, DESV-AP, PhD, DECVP, recently co-authored a study that successfully demonstrated the effectiveness of a highly standardized porcine model for assessing dermal and epidermal wound healing.

When it comes to neuropathology studies, there is no one-size-fits-all approach.

Learn what triggers minimal Apoptosis/Single Cell Necrosis in nonhuman primate brain in this whitepaper coauthored by StageBio senior pathologist Dr. Joy Gary.

Learn how StageBio uses Tissue Cross Reactivity studies (TCR) and how it helps clinical researchers when identifying off target binding.

Biotherapeutics like cell and gene therapies, nucleic acids, and proteins show promise for treating many neurodegenerative disorders.

Discover Dr. Quinci Plumlee's collaboration on the male rat's reproductive system in "Toxicologic Pathology, A Primer".

While the Marburg virus disease (MVD) is deadly to humans, the filovirus responsible for it—i.e., the Marburg virus (MARV)—is carried asymptotically in Egyptian rousette bats (ERBs).

When it comes to preclinical research and clinical trials, the logistics outside the lab are as crucial as the processes and handling of samples inside the lab. In other words, frozen samples must be handled with care and transported in a timely manner to make sure project milestones are reached.

The limitations of current PFO occluders According to the Mayo Clinic, approximately one in four people have a hole between the left and right chambers of the heart known as a patent foramen ovale, or PFO. First-generation PFO occluders were designed to stop any resulting blood flow between the two chambers.

StageBio scientists co-author study that demonstrate the benefit of 3D-printed scaffolds with geometric mismatches to treat periorbital bony defects

Toxicologic pathologists play a critical role in helping to determine the immunosafety of biopharmaceutical therapies.

Products such as cytotoxic chemotherapeutics and AAV-based gene therapies are associated with gangliotoxicity. Despite this, prior toxicology guidance provided no recommendations for which sensory and autonomic ganglia to evaluate in nonclinical general toxicity studies.

A published review on the broadening applications of ISH in drug research and development

While the connections between TP53 mutations and cancer have been well studied, an estimated 200 missense variants remain unclassified.

While a link has been observed between bacterium and the development of gastric and colorectal cancer, there has been little evidence to suggest a connection between intestinal microbiota and the carcinogenesis of extra-intestinal organs.

StageBio pathologist Dr. Shannon Kirejczyk authored a 2023 paper to evaluate host responses and virus clearance in Egyptian rousette bats (ERBs) experimentally infected Kasokero virus (KASV) using histopathology and whole-slide digital image analysis.

To better understand the role that the microbiome plays in the formation of gastrointestinal (GI) diseases among captive marmosets, StageBio senior pathologist Dr Sureshkumar Muthupalani partnered with researchers to study a novel GI syndrome

For reasons not fully understood, captive marmosets are commonly diagnosed with chronic gastrointestinal (GI) diseases—more so than other diseases.

To understand how various rates of water evaporation impact wound healing, StageBio director of digital and quantitative pathology Dr. Thomas Lemarchand and Image Analyst Fabian Kukla co-authored a study to test in vitro and in vivo water evaporation rates from the cellulose dressing epicitehydro when combined with different secondary dressings.

Whitepaper Addresses Challenges of Bioabsorbable Implants in Preclinical Animal Studies and Data Interpretation.

Complex biological responses are induced by implanted medical devices, and nonclinical studies are a common and often critical step for the safety assessment of these devices.

Many pathologists do not evaluate sensory ganglia in cynomolgus monkeys (Macaca fascicularis) during nonclinical toxicology investigations.

Proper and effective wound care mandates the controlling of the homeostatic wound state.

The National Toxicology Program (NTP) has conducted more than 500 short-term and 2-year toxicology and carcinogenicity studies in rodents: throughout the course of these studies, several chemicals tested contributed to the development of oral cancer.

StageBio senior pathologist co-authors study on the use of 3D-printed bioactive scaffolds for restoring midfacial bone defects.

IThe International Harmonization of Nomenclature and Diagnostic Criteria for Lesions Project (INHAND) has published an article, “Proliferative and Nonproliferative Lesions of the Rat and Mouse Central and Peripheral Nervous Systems: New and Revised INHAND Terms,” which can be accessed here. This article revises two existing terms and defines nine new terms for the rat and mouse central nervous system (CNS) and peripheral nervous system (PNS).

Healthcare providers often rely on embolic coils to isolate a patient’s aneurysm from artery blood flow and prevent rupturing. However, embolic coils are associated with complications such as recanalization, compacted coils (as a result of pulsing arterial flow), improper healing of an aneurysm, and others—all of which may result in the growth or rupturing of an aneurysm, as well as the creation of additional aneurysms.

Currently, healthy animal models play a critical role in the safety evaluation of a drug or health product. However, pharmaceutical companies and regulatory authorities are becoming increasingly interested in the use of animal models of disease (AMD) to better understand the potential risk of a diseased population. Recent publications and recommendations for the use of these models by regulators make the growing interest of the application of AMD highly evident.

What is self-amplifying mRNA technology? Self-amplifying mRNA (SAM) technology is a relatively novel approach in vaccinology. It consists of an engineered replication-deficient alphavirus genome encoding an RNA-dependent RNA polymerase and the gene of the target antigen. The benefit that SAM technology holds over conventional vaccinology is its potential for the rapid development and large-scale production of a vaccine in the event of an unpredictable epidemic outbreak.

In a recent ACT 2021 Talking Tox webinar titled “Safety of E-Cigarette Products – A Toxicological Challenge,” I provided scientific guidance on pathology endpoints for inhalation studies. During my segment, I discussed the special planning necessary to optimize histopathology results when studying test articles dosed via the inhalation route (nose-only, head, or whole-body exposure).

Immunohistochemistry (IHC) and immunofluorescence (IF) are molecular assays that involve the use of antibodies to detect specific proteins within tissues on microscope slides

Good Laboratory Practices (GLP) refers to a system where non-clinical health and safety studies are carried out, planned, monitored, recorded, archived and reported.