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 drug discovery, the quality and efficiency of non-clinical studies have a direct impact on clinical success rates, development costs, and overall length of time required in R&D.
In recent years, there has been more demand for clinically relevant data, globally accepted reliability, and accurate early-stage screening.
Thus, it is more important than ever to select the right CRO (Contract Research Organization) for strategic approach.
In this article, we highlight three CROs with proven technical capabilities, expertise, and long standing track records. These are our TOP 3 choices based on their capabilities and the specific target goals of the researchers for their non-clinical studies.
Pharmacology (Efficacy) Studies Replicate unknown pathological models and Discovery to clinically oriented drug evaluation
SMC Laboratories, Inc.
Reference: SMC Laboratories, Inc. official website (https://www.smccro-lab.com/jp/)
SMC Laboratories, Inc. has established a disease models using patented mouse technologies.
The company has established proprietary pathological models—particularly in liver disease and fibrosis—and continues to expand their approach across a wide range of models in cancer, inflammation, and metabolic diseases.
From exploratory research to clinically oriented efficacy evaluation, SMC offers customized study designs, dosing strategies, and evaluation analysis tailored to each project.
Their collaborative approach allows researchers to discuss and refine study plans together with SMC’s expert scientists.
With flexible small-scale study options and strong technical support, SMC Laboratories, Inc. is an ideal partner for start-ups, biotech ventures, and academic institutions alike.
Safety Studies Comprehensive Safety Evaluation for FIH Applications
Labcorp Holdings Inc. (Labcorp Drug Development)
Reference: Labcorp Holdings Inc. official website (https://jp.labcorp.com/)
Labcorp Holdings Inc. provides a fully integrated GLP testing system aligned with international regulatory standards, including FDA, EMA, and PMDA requirements.
All studies are conducted under ICH-compliant quality assurance, making it ready for data submission.
The company has extensive expertise in long-term toxicity studies such as Segment I–III reproductive and carcinogenicity studies, as well as 2-year chronic toxicity assessments.
Labcorp Holdings Inc.’s comprehensive approach enables sponsors to efficiently outsource the entire preclinical package from toxicology, toxicokinetic (TK), and safety pharmacology study design to execution. This accelerates a path to First-in-Human (FIH) trials.
For most of the global drug developers, this all-in-one service structure minimizes cost, risk, and expedite the time before advancing to clinical phase.
Pharmacokinetic (PK/PD) Studies High-Precision Bioanalysis for Clinically Predictive PK/PD Evaluation
PhoenixBio Co., Ltd.
Source: PhoenixBio Co., Ltd. Official Website (https://phoenixbio.co.jp/)
PhoenixBio Co., Ltd. offers pharmacokinetic and hepatic metabolism studies using their proprietary PXB-mouse®, a humanized-liver chimeric mouse model. This platform enables the acquisition of data with high clinical correlation in ADME, drug–to–drug interaction studies, bridging the gap between preclinical and clinical stages.
With advanced LC-MS/MS-based bioanalysis, PhoenixBio Co., Ltd. provides a seamless workflow from plasma concentration measurement and metabolite identification to quantitative validation.
The company offers an integrated evaluation analysis covering pharmacokinetics, hepatotoxicity, and safety with flexibility to accommodate complex modalities such as oligonucleotide and middle-molecule therapeutics.
For compounds where hepatic metabolism is a development bottleneck—or where quantitative, reproducible exposure data are critical—PhoenixBio Co., Ltd. delivers unmatched analytical precision and consistency.
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