Translucence Biosystems, Inc. is a tissue clearing and whole-brain imaging company in Irvine, California, founded in 2018 as a spin-out of the Sunil Gandhi laboratory at the University of California, Irvine.[S2] It sells both instruments and reagents and performs contract imaging work, so the first thing to establish with them is which of the two a program needs.[S3][S4] This profile summarizes the products, the contract services, stated compliance information, and company facts most relevant to US sponsors.
Products and services
What is sold as a product
The product line covers the Mesoscale Imaging System, described as a modified light-sheet microscope built on a ZEISS platform; Stitchy, an image stitching software tool; and three tissue clearing kits priced between about 895 and 995 US dollars.[S3] A laboratory that intends to run imaging in house buys these. A sponsor outsourcing a study does not.
What is offered as a contract service
Contract work is offered as custom services and as full-pipeline services, with named applications in Alzheimer's disease, Parkinson's disease and the brain distribution of therapeutic antibodies.[S4] The last of these is the application most likely to matter to a drug developer: whole-brain light-sheet imaging can show where an antibody or other biologic reaches within intact tissue, which a sectioned-slide workflow cannot show in the same way. These are anatomical and distribution readouts. They describe where a molecule went, not whether it worked, and they do not substitute for the efficacy or safety endpoints of a study.
Who handles the animals
The services page sets out two arrangements: the client performs the animal procedures and ships fixed samples, or the client works with Translucence and the animal procedures are handled as part of the engagement.[S4] Where the second route runs, and under whose oversight, is not stated on the pages reviewed. A sponsor choosing that route should establish which facility houses the animals and what oversight applies there before the study starts.
Quality, compliance, and animal welfare (as stated by the company)
No compliance statements were found. The pages reviewed contain no GLP claim, no AAALAC accreditation, no USDA registration, no OLAW Animal Welfare Assurance, no Institutional Animal Care and Use Committee statement and no ISO or CLIA certification. For a company whose default arrangement is to receive fixed tissue, most of those would not apply; for the arrangement in which animal procedures are handled as part of the engagement, they would. That is the gap a sponsor needs to close by asking. 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]
5270 California Avenue, Suite 300, Irvine, CA, United States[S2]
Founded
2018, as a spin-out of the Sunil Gandhi laboratory at the University of California, Irvine[S2]
Ownership
Private; no stock listing and no SEC registration found[S2]
Employees and revenue
Not published
Products
Mesoscale Imaging System (a modified ZEISS light-sheet microscope); Stitchy image stitching software; three tissue clearing kits[S3]
Contract services
Custom services and full-pipeline services covering Alzheimer's disease, Parkinson's disease and antibody brain distribution[S4]
Animal handling
Either the client ships fixed samples, or animal procedures are handled as part of the engagement; the facility for the latter is not stated[S4]
Funding
The company states NIH BRAIN Initiative funding. A University of California, Irvine article reports two NIH SBIR awards; the term SBIR does not appear on the company site[S1][S5]
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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