Content Library

Key Pathology Considerations for Successful Preclinical Medical Device Studies, from Protocol to Report

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.

A highly standardized and reproducible porcine model for the evaluation of wound healing

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.

Running Successful Neuropathology Studies: Sampling & Preparing Nervous System Tissues for Microscopic Evaluation

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

A Hypothesis on minimal Apoptosis/Single Cell Necrosis in the Primate Brain Following Ice-Cold Saline Perfusion

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

What Is a Tissue Cross Reactivity Study?

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

Journal Article Offers Insights on Toxicologic Neuropathology of Novel Biotherapeutics

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

StageBio Pathologist Co-authors Chapter on Male Reproductive System in Toxicologic Pathology Textbook

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

Paper Provides New Insights into the Immunological Resistance of MARV Virus in Bats

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).

3 Ways to Ensure Optimal Transportation for Your Frozen Samples

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 feasibility and safety of a novel Encore PFO closure device in long-term porcine model

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.

3D-printed scaffolds with geometric mismatches promote repair in periorbital bony defects of skeletally mature Yucatan minipigs

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

Opinion Article Proposes Practical Framework for Evaluating and Assessing Adversity of Immune System Changes When Evaluating Immune-Modulating Therapeutics

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

Paper Outlines Points to Consider When Sampling & Processing Sensory Ganglia in Non-clinical Tox Studies

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.

StageBio Director of Digital and Quantitative Pathology co-authors review of ISH technique in drug research and development

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

StageBio senior pathologist contributes to study that uncovers common gene expression across diverse TP53 variants

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

StageBio senior pathologist co-authors study demonstrating role of H. hepaticus in breast carcinogenesis

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.

Study demonstrates immune response against KASV in Egyptian rousette bats

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.

StageBio senior pathologist co-authors study linking increased C. perfringens to GI disease and intestinal (duodenal) strictures in marmosets

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

StageBio senior pathologist co-authors analysis that observes differences in microbiome of healthy marmosets and marmosets with IBD

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

StageBio’s Dr. Thomas Lemarchand and Fabian Kukla co-author study demonstrating impact of water evaporation rate on dermal versus epidermal wound healing

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.

Pathology of Bioabsorbable Implants in Preclinical Studies

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

StageBio pathologists were members of the STP SRPC Medical Device Implant Site Evaluation working group that published a recent Points to Consider article in Toxicologic Pathology

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.

StageBio pathologists co-author article on the underestimated role ASN (autophagy of sensory neurons) plays in sensory ganglia

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

StageBio Pathologists Co-author Article Demonstrating Wound Dressings with High Evaporation Rates Improve Healing

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

StageBio pathologist co-authors review on contributing lifestyle factors of oral cancer

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.

The use of 3D-printed scaffolds to treat midfacial critical-sized bone defects

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

StageBio pathologists are members of the INHAND working group for CNS and PNS of the rat and mouse

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).

StageBio pathologist co-authors study on shape memory polymer foam-coated coils for the treatment of aneurysms

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.

StageBio senior pathologist co-authors article on the use of animal models of disease for nonclinical safety testing

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.

Evaluating the safety of a self-amplifying mRNA vaccine in rats

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.

3 Keys to Successful Pathology Endpoints in Inhalation Toxicology Studies

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).

IHC or IF: Which is Best for My Study?

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

GLP & Non-GLP: What's the Difference?

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

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