StageBio is a histopathology contract research organization headquartered in Frederick, Maryland. It brands itself as "StageBio: The Histopathology CRO"[S1] and states that it "is dedicated exclusively to histopathology and comprehensive sample management."[S1] That focus defines how it fits into a program: StageBio does not dose animals or run in-life studies, so it supplies the pathology endpoints for studies conducted by a sponsor or by another CRO. This profile summarizes the services, sites, stated compliance information, and company facts most relevant to US sponsors.
Services relevant to US drug developers
Histology and toxicologic pathology
Histology covers necropsy support, tissue processing, embedding, sectioning and slide production, with the company stating that "our histology services and facilities are GLP-compliant"[S2] and listing bone decalcification and oversized tissue processing in paraffin and plastics among its capabilities.[S2] On the pathology side the company states that its "pathology team is SEND-ready and eager to work with you on your next GLP or non-GLP study."[S3] Study types listed include rodent and non-rodent toxicity, safety and discovery studies, target animal safety studies, six-month transgenic rodent carcinogenicity studies, two-year rodent carcinogenicity studies, and animal models of human disease.[S3] Species covered for pathology evaluation are listed as rats and mice including transgenic strains, dogs, human tissue, non-human primates, pigs and mini pigs, livestock including cattle, sheep, goats, chickens and turkeys, companion animals, rabbits, guinea pigs, chinchillas and hamsters.[S3] Peer review and pathology working groups are offered alongside primary evaluation.[S3]
Specialty pathology: neuro, ocular, and medical device
Three specialty areas are described separately. For neuropathology the company states that it supports "200+ GLP and non-GLP neuropathology studies every year, spanning therapies under development to treat Alzheimer's, Parkinson's, ALS, multiple sclerosis, and beyond,"[S6] with validated immunohistochemistry panels for neurons (NeuN, MAP2), gliosis and neuroinflammation (GFAP, IBA-1) and myelination (MBP and Luxol Fast Blue).[S6] For ocular work it states that "for over 20 years, StageBio has advanced vision science through our expert pathology insight, GLP-compliant reporting, and agile scientific collaboration,"[S7] covering twelve named disease models and study types including bovine corneal opacity and permeability studies, ocular device and implant studies and intravitreal injection studies.[S7] For medical devices it states that it has "conducted more than 1,000 Non-GLP and GLP medical device pathology studies across multiple therapeutic areas,"[S5] spanning cardiovascular, nervous system, musculoskeletal and dental, and skin and wound healing categories with stated annual study volumes for each.[S5]
Tissue cross-reactivity, biomarkers, and digital pathology
The company offers tissue cross-reactivity studies, stating that it "provides tissue cross-reactivity (TRC) studies for monoclonal antibodies and related antibody-based therapeutics, helping drug developers characterize intended and unexpected binding across human tissues,"[S8] run across three independent full human tissue panels and aligned to ICH S6(R1), which the company notes "identifies human-tissue TCR as a recommended component for many monoclonal antibodies and related biologics."[S8] Its biomarker offering is described as "integrated IHC, ISH, and immunofluorescence services underpinned by one of the industry's deepest portfolios of validated tissue biomarkers,"[S9] citing "300+ Antibody Biomarkers covering oncology, neuroscience, inflammation, and various diseases and species."[S9] Digital pathology covers whole-slide imaging, secure digital slide sharing and quantitative image analysis, with brightfield and multiplex fluorescence scanning.[S1]
Specimen archiving
The biorepository is a distinct business line covering storage from ambient to cryogenic conditions at minus 196 degrees Celsius, with the company stating that "GLP-compliant environments, 21 CFR Part 11-compliant LIMS, and end-to-end chain of custody documentation provide complete traceability across all storage conditions."[S4] Stated capacity is 800,000 cubic feet and 25 million samples under management.[S4] For a sponsor this matters because GLP study records and specimens must be retained; archiving arrangements should be set out in the study contract.
Quality and compliance (as stated by the company)
GLP is claimed broadly across the service pages, for histology facilities,[S2] pathology,[S3] the biorepository[S4] and the specialty areas. No page reviewed names the governing US GLP regulation. The only CFR citation found anywhere on the site is 21 CFR Part 11 for electronic records in the archiving LIMS,[S4] which is a different regulation from 21 CFR Part 58, the GLP regulation for nonclinical laboratory studies.[R2] Sponsors should confirm in the protocol which regulation a study follows and that the pathology report will carry the required compliance statements. The Freiburg facility was described at acquisition as adding "a GLP/GCLP-compliant lab facility and staff in Germany."[S11] No AAALAC, USDA, OLAW, IACUC, ISO or CLIA statement was found on the pages reviewed, which is consistent with a laboratory that receives tissue rather than housing animals. AAALAC International accreditation is a voluntary evaluation of an institution's animal care and use program, re-evaluated every three years,[R3] and USDA registration and an OLAW Animal Welfare Assurance relate to the Animal Welfare Act and the PHS Policy respectively;[R4][R5] none of these establishes GLP compliance, which applies to individual studies.[R2] FDA does not approve or certify laboratories; registration with FDA does not denote approval.[R6]
Company facts
Brand and legal name
StageBio; the site footer shows the legal entity as HSRL Holdings LLC[S1]
Headquarters
8415 Progress Drive, Frederick, Maryland 21701, United States[S1]
Ownership
Private; a portfolio company of Ampersand Capital Partners[S10]
Origin
Created by the merger of Histo-Scientific Research Laboratories (HSRL) and Vet Path Services, described as recent in April 2019[S10]
Acquisitions
Merged with Tox Path Specialists, LLC in April 2019; acquired TPL Path Labs of Freiburg, Germany in October 2020[S10][S11]
Current sites
Frederick, MD (headquarters); Maurertown, VA (archiving, over 250,000 cubic feet); Freiburg, Germany[S1]
Staff
Stated as 20+ pathologists and 50+ scientists on some pages and 30+ board-certified veterinary pathologists on others; no total headcount is published[S3][S12]
FDA ? "Is It Really FDA Approved?" (FDA does not approve health care providers, including laboratories; registration does not denote approval); FDA Compliance Program 7348.808 (GLP inspections of nonclinical laboratories). https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved (accessed 2026-09-03)
3 Recommended Contract Research Organizations
for Non-Clinical Studies
— by Target goal and Expertise
In non-clinical development, the choice of contract research organization shapes the quality of the data and the time it takes to reach the next decision. Below, three CROs are introduced by the type of study they support: pharmacology (efficacy) studies, safety studies, and pharmacokinetic (PK/PD) studies. Each summary describes the services the company offers so that you can match a provider to your target and development objective.
Pharmacology (Efficacy) StudiesDisease-Relevant Models for Translational Drug Evaluation
Reference: SMC Laboratories, Inc. official website (https://www.smccro-lab.com/)
SMC Laboratories, Inc.
SMC Laboratories is a specialized non-clinical CRO focused on in vivo pharmacology and efficacy studies using disease-relevant animal models, particularly in fibrosis, inflammation, metabolic diseases, and oncology.
Areas of Expertise
Disease-Relevant Model Portfolio
SMC Laboratories offers models covering the liver, lung, kidney, intestine, and oncology. Its portfolio includes the proprietary STAM™ model for MASH, fibrosis, and hepatocellular carcinoma.
Study Design Based on Target Biology
Study plans are developed around the target biology, mechanism of action, disease stage, and development objective. Pharmacological endpoints can be combined with histopathology, biomarkers, and disease-specific readouts.
Support from Target Validation to Proof of Concept
With experience from more than 1,000 studies for clients in 30 countries, SMC Laboratories supports programs from target validation and candidate selection through in vivo proof-of-concept studies.
Safety StudiesComprehensive Safety Assessment for Preclinical Development
Reference: Charles River Laboratories official website (https://www.criver.com/)
Charles River Laboratories
Charles River provides non-clinical toxicology and safety assessment services for programs ranging from exploratory safety studies to IND-enabling development.
Areas of Expertise
General Toxicology Across Study Designs
Services include single- and repeat-dose toxicology, dose-range finding, and general toxicology studies across multiple species and administration routes.
Non-GLP and GLP Study Support
Charles River supports both non-GLP and GLP studies, allowing sponsors to progress from early safety characterization to studies intended for regulatory submissions.
Integrated IND-Enabling Safety Assessment
Toxicology studies can be integrated with toxicokinetics, clinical pathology, histopathology, and safety pharmacology to support interpretation and IND-enabling safety packages.
Pharmacokinetic (PK/PD) StudiesConnecting Drug Exposure with Pharmacological Response
Reference: Inotiv official website (https://www.inotiv.com/)
Inotiv
Inotiv provides integrated PK/PD, DMPK, and bioanalytical services to characterize drug exposure and its relationship with pharmacological response.
Areas of Expertise
Pharmacokinetic Characterization
PK studies characterize exposure, half-life, clearance, and other pharmacokinetic parameters needed to understand how a candidate behaves in the selected model.
Exposure–Response Evaluation
Pharmacokinetic data can be combined with pharmacodynamic endpoints and bioanalysis to evaluate the relationship between drug exposure and pharmacological response.
Integrated DMPK and Development Support
Integrated DMPK, pharmacology, and safety information supports candidate comparison, dose selection, dosing-frequency optimization, and decisions about subsequent preclinical development.
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