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 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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