Battelle Memorial Institute is an independent nonprofit applied science and technology organization in Columbus, Ohio,[S2] which states that it has served government and industry "since its founding in 1929."[S1] Its scope extends well beyond drug development: the locations page lists sites working on missile defense, aviation security, cyber capability, environmental testing and ecological observation.[S3] This profile covers only the part relevant to a drug developer, the biomedical work centered on the West Jefferson, Ohio facility, which the company describes as supporting "a variety of research work from pharmaceutical research to nonclinical research."[S3]
What is offered for nonclinical drug development
Biocontainment and medical countermeasures
One documented capability is high-containment infectious disease and countermeasure work. The company reports 22,000 square feet of biosafety level 3 laboratory and holding space.[S5] Named work in that area covers outbreak preparedness and response, and testing of therapeutics, prophylaxis and diagnostics.[S5] An Aerosol Research and Component Assessment chamber supports aerosol studies, and a Highly Toxic Materials Laboratory tests chemical warfare agents and other highly toxic materials in animal models.[S5] The cited page presents this capability for biodefense and medical countermeasure programs, which is a different kind of work from conventional small molecule or biologic development.
Toxicology, new approach methodologies, and medical devices
The life sciences research page refers to "toxicology, assay development and validation services, and toxicology and pharmacology for support for investigational new drug studies."[S4] An IND is not "approved" by FDA: under 21 CFR 312.40 it goes into effect 30 days after FDA receives it unless FDA imposes a clinical hold.[R1] A CRO may conduct and report nonclinical studies that a sponsor includes in an IND, but it cannot guarantee that FDA will allow the clinical investigation to proceed. The same page describes new approach methodologies, stating that they "apply advanced in vitro and microphysiological systems to generate earlier, more human-relevant evidence of safety, efficacy, and biological response."[S4] Separately, the medical device business states more than sixty-five years of developing regulated medical products,[S6] spanning human-centered design, drug delivery, device design and development and neurotechnology.[S6] No dedicated DMPK or ADME service page and no standalone pathology service page were found on the pages reviewed.
Quality, compliance, and animal welfare (as stated by the organization)
GLP. The life sciences page states: "We offer regulatory-compliant environments that adhere to strict GLP, GCP and GMP practices."[S4] The company's website does not name a specific GLP regulation (FDA 21 CFR Part 58, EPA 40 CFR Part 160/792, or OECD GLP) for its facilities.[S4] GLP compliance is determined study by study under the applicable regulation, so sponsors should confirm in the protocol which regulation their study will follow and that the final report will carry the study director's compliance statement and the quality assurance unit's statement.[R2] Note that GLP, GCP and GMP are three separate frameworks covering nonclinical studies, clinical trials and manufacturing respectively; a single sentence naming all three does not tell a sponsor which applies to a specific study.
No AAALAC accreditation, USDA registration, OLAW Animal Welfare Assurance, Institutional Animal Care and Use Committee or three Rs statement was found on any page reviewed for this profile, even though the organization describes animal holding space at biosafety level 3 and animal model testing of highly toxic materials.[S5] That is an absence in those pages, not a finding about the status of the organization. It is worth recording rather than glossing over: for an organization that plainly conducts animal work, a sponsor cannot verify oversight arrangements from the website and should request the current site-specific status directly. 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]
Organization facts
Legal name
Battelle Memorial Institute, operating publicly as Battelle[S2]
Headquarters
505 King Avenue, Columbus, Ohio 43201, United States[S3]
Total headcount not published; the homepage cites more than 1,200 scientists and engineers with advanced degrees, which is a subset rather than a total[S1]
Site relevant to drug development
West Jefferson, Ohio, described as supporting pharmaceutical and nonclinical research[S3]
Other sites
Columbus, OH; Norwell, MA; Ponce Inlet, FL; Boulder, CO; Charlottesville, VA; Egg Harbor Township, NJ; Huntsville, AL; Beavercreek, OH; Arlington, VA; Chantilly, VA; Washington, DC; and Chelmsford, United Kingdom[S3]
Biocontainment (company statement)
22,000 square feet of BSL-3 laboratory and holding space[S5]
Named biomedical capabilities
Outbreak preparedness and response; therapeutics, prophylaxis and diagnostics testing; aerosol research chamber; highly toxic materials laboratory; new approach methodologies; medical device development[S4][S5][S6]
Quality statement
Regulatory-compliant environments described as adhering to GLP, GCP and GMP practices; no regulation is named[S4]
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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