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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 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.
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)
Labcorp Holdings Inc.
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.
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.
By Therapeutic Area
Disease Animal Models
and Reviews
Proven Capability, Expertise and Track Record
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