IBT Bioservices is the contract research business of Integrated Biotherapeutics, LLC, based at 4 Research Court in Rockville, Maryland.[S6] The company describes itself as specializing "in providing comprehensive contract research services, offering a unique platform to engage in diverse projects spanning preclinical and clinical research."[S1] It took its current name in February 2023, when it moved its vaccine and therapeutic pipeline into a separate company, AbVacc, Inc., and focused the remaining business on contract research.[S7] The reviewed service pages focus on infectious disease models[S2] and in vitro immunoassays[S3]. This profile summarizes the services, facilities, stated compliance information, and company facts most relevant to US sponsors.
Nonclinical services relevant to US drug developers
In vivo infectious disease models
The company states that it "provides full-service preclinical in vivo testing services with 15+ established animal models for drug and vaccine development."[S2] Bacterial models named on that page include enterotoxigenic E. coli, Staphylococcus aureus in skin and soft-tissue infection, pneumonia and bacteremia designs, Streptococcus pneumoniae pneumonia, and toxic shock syndrome "caused by Staphylococcal enterotoxins A, B, C and TSST-1."[S2] Viral models named are chikungunya, dengue, influenza, respiratory syncytial virus and Zika, supported by an in-house AG129 immunodeficient mouse colony.[S2] Additional listed services are tissue processing and histopathology, live animal imaging, dermatology models, custom animal model development, rodent breeding, vivarium rental, immunogenicity testing, vaccine adjuvant screening, and PK, PD and biodistribution work.[S2]
Filovirus work and biosafety levels
The company states plainly how its containment is arranged: "IBT's capabilities include BSL-2 testing. We offer BSL-3 and ?4 testing capabilities through our partners."[S2] Its own Rockville facility is described as BSL-2, with some BSL-3 and BSL-4 capability available through partnerships.[S1] For filoviruses the company says its "researchers have extensive experience with filovirus animal models,"[S5] covering Ebola, Sudan, Bundibugyo and Marburg viruses; surrogate pseudotype work can run in-house at BSL-2, while authentic virus work runs at partner BSL-4 laboratories.[S5] Sponsors placing high-containment studies should establish which organization will hold the study, where the animals will be housed, and which quality system applies at each site.
In vitro assays and regulated testing
In vitro work covers antiviral, antibacterial and immunoassay panels, including microneutralization, plaque reduction neutralization, pseudovirus neutralization, ELISA in several formats, Luminex multiplex assays and flow cytometry.[S3] The company offers these under three named compliance frameworks. Its GLP assays are listed as "Luminex Testing, Neutralization Assays, HPLC Analysis, ELISA."[S4] Its GMP assays cover sterility testing to USP 71, PCR-based mycoplasma testing, SDS-PAGE, western blot, A280 measurement, host cell protein analysis and bacterial endotoxin testing.[S4] GCLP is described by the company as implementing "Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) principles" for clinical trial sample work.[S4]
Quality, compliance, and animal welfare (as stated by the company)
GLP is offered at the assay level. The company presents GLP as an option on specific assays rather than as a facility-wide status, listing four assay types under a GLP heading.[S4] It defines GLP as "a set of conditions, processes, and documentation which support the conduct of nonclinical studies performed in a laboratory setting intended to assure the quality and integrity of data."[S4] No statement naming 21 CFR Part 58, the EPA GLP regulations or the OECD principles as the governing regulation was found on the pages reviewed. Because GLP compliance attaches to an individual nonclinical laboratory study,[R2] sponsors should confirm in the protocol which regulation a study will follow, who the study director is, and that the final report will carry the required compliance statements.
Accreditation and registration. The animal services page displays "OLAW Accredited; USDA Certified"[S2] and states that the company maintains an "in-house IACUC, experienced technicians, veterinarian support & 24/7 secure-access."[S2] Two points are worth noting about the wording. NIH OLAW does not accredit facilities; it receives and approves an Animal Welfare Assurance under the PHS Policy,[R5] and USDA registers research facilities under the Animal Welfare Act rather than certifying them.[R4] No assurance or registration numbers and no AAALAC accreditation statement were found on the pages reviewed; that is an absence in those pages, not a finding about the status of the company. Separately, Integrated Biotherapeutics, LLC holds an ISO/IEC 17025:2017 accreditation for biological testing from Perry Johnson Laboratory Accreditation, certificate L26-201, with an initial accreditation date of March 8, 2026 and expiry of April 30, 2028; its scope covers three protein methods ? protein concentration by spectrophotometer, purity by SDS-PAGE and identification by western blot ? and is not a facility-wide or GLP-equivalent accreditation.[S6] 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
Legal name
Integrated Biotherapeutics, LLC, trading as IBT Bioservices[S6]
Headquarters
4 Research Court #300, Rockville, MD 20850, United States[S6]
Founded
Not stated on the pages reviewed
Name history
Renamed from Integrated BioTherapeutics to IBT Bioservices effective February 2023, when the R&D pipeline was spun off into AbVacc, Inc.[S7]
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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