Nonclinical Efficacy Testing » Non-Clinical CROs and Agencies » Texas Biomedical Research Institute

Texas Biomedical Research Institute

Table of Contents
Table of Contents

Texas Biomedical Research Institute is an independent nonprofit research institute in San Antonio, Texas, founded in 1941 and operating from a single 200-acre campus with more than 360 staff.[S2] It is not a conventional contract research organization, and the difference matters for how a sponsor engages with it. Two capabilities set it apart: it holds what it describes as the only privately owned biosafety level 4 laboratory in the United States,[S3] and it hosts the Southwest National Primate Research Center, which it describes as the only National Primate Research Center with on-site access to BSL-4 containment.[S4] This profile summarizes those capabilities, how commercial sponsors can contract work, and the institute's stated compliance information.

Containment and the primate center

The institute states that its biosafety level 4 laboratory is the only privately owned facility of its kind in the United States.[S3] BSL-4 containment is required for work with agents such as filoviruses for which there is no available vaccine or therapy, and very few sites worldwide can host it. The Southwest National Primate Research Center is one of the National Primate Research Centers and holds more than 2,500 non-human primates; the institute describes it as the only such center with on-site access to BSL-4 containment.[S4] For a sponsor developing a medical countermeasure that requires non-human primate studies under high containment, the combination of the two on one campus is the practical reason to approach this institute rather than a commercial CRO.

How a commercial sponsor engages

Two routes are described. The Applied Science and Innovation group handles fee-for-service work, contract research and licensing for commercial partners.[S5] Separately, work involving the primate center is requested through the center's own application process.[S4] Because the institute is a nonprofit whose primary business is its own research programs, sponsors should expect the engagement model, timelines and intellectual property terms to differ from those of a commercial CRO, and should raise those points early.

Quality, compliance, and animal welfare (as stated by the institute)

The institute states AAALAC accreditation held since 1973, annual inspection by the US Department of Agriculture Animal and Plant Health Inspection Service, an Institutional Animal Care and Use Committee, and adherence to Public Health Service policy.[S6] One wording point: that page names the Office for Human Research Protections rather than the Office of Laboratory Animal Welfare in connection with the PHS policy. OHRP oversees human subjects research; the office responsible for laboratory animal welfare assurances is OLAW.[R5] The statement is quoted as published, and the discrepancy is noted rather than corrected silently. 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] This profile does not evaluate the institute's animal care program; the statements above are its own.

GLP. A defense-related press release from July 2026 refers to GLP and FDA-facing work.[S7] No GLP statement was found on the service pages themselves, so a sponsor needing a GLP study should confirm the scope, the governing regulation and the quality assurance arrangements directly.[R2]

Institute facts

NameTexas Biomedical Research Institute[S1]
LocationSan Antonio, Texas, United States; a single campus of about 200 acres[S2]
Founded1941[S2]
OwnershipIndependent nonprofit research institute[S2]
StaffMore than 360[S2]
ContainmentDescribed as the only privately owned BSL-4 laboratory in the United States[S3]
Primate centerSouthwest National Primate Research Center, holding more than 2,500 non-human primates; described as the only National Primate Research Center with on-site BSL-4 access[S4]
Routes for sponsorsApplied Science and Innovation for fee-for-service, contract research and licensing; the primate center's own application process for SNPRC work[S4][S5]
Animal welfareAAALAC accredited since 1973; annual USDA APHIS inspection; IACUC; adherence to PHS policy (the page names OHRP rather than OLAW)[S6]
GLPReferred to in a July 2026 defense-related press release; not found on the service pages[S7]
RevenueNot published
Websitewww.txbiomed.org

References

  1. Texas Biomedical Research Institute ? Home. https://www.txbiomed.org/ (accessed 2026-09-03)
  2. Texas Biomedical Research Institute ? About. https://www.txbiomed.org/about/ (accessed 2026-09-03)
  3. Texas Biomedical Research Institute ? Biosafety and containment. https://www.txbiomed.org/biosafety/ (accessed 2026-09-03)
  4. Southwest National Primate Research Center (SNPRC). https://www.txbiomed.org/southwest-national-primate-research-center/ (accessed 2026-09-03)
  5. Texas Biomedical Research Institute ? Applied Science and Innovation. https://www.txbiomed.org/applied-science-and-innovation/ (accessed 2026-09-03)
  6. Texas Biomedical Research Institute ? Animal welfare and compliance. https://www.txbiomed.org/animal-welfare/ (accessed 2026-09-03)
  7. Texas Biomedical Research Institute ? News (defense-related contract, July 2026). https://www.txbiomed.org/news/ (accessed 2026-09-03)
  8. 21 CFR Part 58 ? Good Laboratory Practice for Nonclinical Laboratory Studies (§58.1 scope; §58.3 definitions; §58.35 quality assurance unit), eCFR. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-58 (accessed 2026-09-03)
  9. AAALAC International ? FAQs ("voluntary accreditation program"; re-evaluation every three years). https://www.aaalac.org/accreditation-program/faqs/ (accessed 2026-09-03)
  10. USDA APHIS ? Animal Welfare Act: research facilities must obtain a registration; Animal Care inspections. https://www.aphis.usda.gov/awa/public-search (accessed 2026-09-03)
  11. Public Health Service Policy on Humane Care and Use of Laboratory Animals (Animal Welfare Assurance submitted to NIH OLAW). https://grants.nih.gov/policy-and-compliance/policy-topics/animal-welfare/laws-regulations/phs-policy (accessed 2026-09-03)
  12. 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
SMC Laboratories, Inc.
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
Charles River Laboratories
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
Inotiv
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.

By Therapeutic Area
Disease Animal Models
and Reviews
Proven Capability, Expertise and Track Record
Top 3 Non-Clinical CRO Services