CBSET, Inc.

CBSET, Inc. is a preclinical translational research organization in Lexington, Massachusetts, founded in 2006 and formally named Concord Biomedical Sciences and Emerging Technologies, Inc.^[S1][S7] It describes itself as a preclinical translational research institute rather than a conventional contract laboratory.^[S2] CBSET states that it houses swine, sheep, calves, rabbits, mice and rats, and operates a purpose-bred swine center.^[S3] The species range is the feature that most affects what can be placed here. Alongside mice and rats, CBSET houses swine, sheep, calves and rabbits, and it operates its own purpose-bred swine center.^[S3] That makes it relevant to programs where the study must be run in an animal large enough to accept a human-scale implant, catheter or delivery device. The work spans implanted devices, combination drug-device products, and drug and cell therapies, with GLP and non-GLP pathology read out in house.^[S4][S5][S6] This profile summarizes the services, facilities, stated compliance information, and company facts most relevant to US sponsors.

Services relevant to US drug developers

Implanted devices and combination products

Device work is described as running from early iteration and mechanistic studies through to large-scale GLP safety assessments, supported by operating suites and several imaging modalities.^[S4] Named areas include cardiovascular research, renal and sympathetic denervation, drug-coated balloons, thrombectomy and thrombolysis, hernia repair meshes and fixation devices, bone and joint health, and oncology.^[S4] Two further service lines, auditory safety and efficacy testing and physician training, appear by name in the site navigation, but their content pages were not reviewed for this profile, so they are listed here without description.^[S9]

Drug and cell-based therapies

For therapeutics, CBSET states that it supports preclinical research from proof of concept through regulatory filing, including IND-enabling GLP studies, and that its scope covers small molecules, biologics and cell-based products.^[S5] Named capabilities include pharmacokinetics and biodistribution, delivery paradigms, drug-material interactions and formulation, controlled-release therapeutics, and combination drug-device products.^[S5] The emphasis on delivery and on drug-material interaction is consistent with the device side of the business, and is worth raising directly: sponsors developing site-delivered or combination products should ask how the proposed study will assess delivery and drug-material interaction: the question is often how the product behaves at the site where it is placed. An IND is not "approved" by FDA: under 21 CFR 312.40 it goes into effect 30 days after FDA receives it unless FDA imposes a clinical hold.^[R1] A CRO may conduct and report nonclinical studies that a sponsor includes in an IND, but it cannot guarantee that FDA will allow the clinical investigation to proceed.

Pathology and morphometry

Histology and histopathology are offered under both GLP and non-GLP, covering slide preparation, primary staining such as Masson trichrome, von Kossa and Movat pentachrome, secondary staining by immunohistochemistry, immunofluorescence and in situ hybridization, tissue biomarker analysis, morphometry and scanning electron microscopy.^[S6] The company states that board-certified veterinary pathologists are on staff full time, along with laboratory animal medicine veterinarians.^[S4][S6] Resin embedding and morphometry matter for implant work in particular, because implant studies generally call for a different embedding and sectioning workflow from routine paraffin histology, and sponsors should confirm whether the proposed workflow includes resin embedding and morphometry.

Facilities and species

The main site in Lexington, Massachusetts is described as a 40,000 square foot facility housing vivariums, catheterization and imaging laboratories, surgical suites, necropsy, histopathology, scanning electron microscopy and biomechanics.^[S3] A second site in Grafton, Massachusetts is a 22,000 square foot swine research center described as AAALAC-accredited and Class A USDA-licensed, supplying purpose-bred swine from a closed colony of purebred Yorkshire pigs.^[S3] Housing is stated for swine, sheep, calves, rabbits, mice and rats, with other species on request.^[S3] Owning the swine colony rather than buying animals in is relevant to study scheduling and to health status, both of which the company cites as reasons for the arrangement.^[S3] A third site in Waltham, Massachusetts is reported to be under construction; the only source located is a company news post reproducing the headline of an external article, so the size and purpose reported there are not treated as confirmed here.^[S10]

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

GLP compliance is claimed for the facilities and for named services, including device safety assessments, IND-enabling studies and pathology reporting.^{[S3][S4][S5][S6]} The company's website does not name a specific GLP regulation (FDA 21 CFR Part 58, EPA 40 CFR Part 160/792, or OECD GLP) for its facilities.^[S3] GLP compliance is determined study by study under the applicable regulation, so sponsors should confirm in the protocol which regulation their study will follow and that the final report will carry the study director's compliance statement and the quality assurance unit's statement.^[R2] The distinction matters here because the same site runs both exploratory device iteration work and regulated safety studies, and the company itself presents them as different offerings.^[S4]

On animal welfare, CBSET states that its facilities are AAALAC-accredited, USDA-licensed and OLAW-Assured, that animal care follows the Animal Welfare Act and the Guide for the Care and Use of Laboratory Animals, and that studies are overseen by an internally governed Institutional Animal Care and Use Committee.^[S3] The Grafton swine center is specifically described as Class A USDA licensed.^[S3] 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] The site also states an excellent record with FDA and USDA.^[S3] That is the company own characterization; inspection outcomes are not published on the pages reviewed, and FDA does not approve or certify testing laboratories.^[R6] This profile does not evaluate the company animal care program.

Ownership and organizational status

Two official statements about the status of CBSET do not sit easily together, and both are reproduced here rather than resolved. A press release dated October 1, 2025 states that the private equity firm Arlington Capital Partners completed a majority growth investment in the company, and that it intends to pursue complementary acquisitions to broaden the service offering.^[S7] Separately, a services page describes the organization as operating as a non-profit 501(c)(3) institute.^[S5] The two company statements use different descriptions of the organizational status, and the reviewed pages do not explain how they relate, so one of these descriptions may be out of date or may refer to a different entity in a restructured group. The About page does not repeat the nonprofit description, and the press release does not address tax status.^[S2][S7] Sponsors for whom the distinction matters, for example where institutional status affects contracting or indirect costs, should confirm the current legal entity directly and, if needed, against public records.

Leadership is co-founder led. Peter M. Markham is President and Chief Executive Officer and a co-founder, and Elazer Edelman of the Harvard-MIT Biomedical Engineering Center is Chairman of the Board and a co-founder.^[S7][S8] The company added a Chief Regulatory and Innovation Officer in 2026 to build a regulatory consulting business unit, which would place advisory work alongside the laboratory services.^[S8] Sponsors should note that a testing laboratory advising on the same submission it supplies data for is a combination worth clarifying in the scope of work.

Company facts