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.
How to read this profile
This is an independent editorial profile. Statements about Translucence Biosystems's services, facilities, accreditations, and compliance are the company's own, quoted or paraphrased from its website and public filings with the source and access date noted. This site has no commercial relationship with Translucence Biosystems, and inclusion here is not an endorsement. Confirm current capabilities and compliance status directly with the company before contracting.
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 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.
Japanese
