Biomere (JOINN Biomere)

Biomere is a preclinical contract research organization in Worcester, Massachusetts that presents itself as "A JOINN Company."^[S1] It was spun out of the University of Massachusetts Medical School in 1996 and acquired in 2019 by JOINN Laboratories, a contract research organization based in China.^[S2] One structural point should be settled before anything else: the company states on its own toxicology page that "the following toxicology services are offered by our parent company JOINN Laboratories,"^[S3] whose facilities are in China. A US sponsor engaging Biomere for GLP toxicology should therefore establish where the study will actually be run. This profile summarizes the services, sites, stated compliance information, and company facts most relevant to US sponsors.

What runs in the United States

The Worcester site is described as focused on non-GLP work: pharmacology, pharmacokinetic and pharmacodynamic studies and early toxicology.^[S4] Sponsors should determine which exploratory studies may be conducted outside the good laboratory practice regulation and which safety studies must fall within it. The second US site is in Richmond, California, operating as JOINN Laboratories CA Inc.^[S5] Sponsors should confirm which of the two would run their work, because the compliance statements differ between them.

Where the GLP toxicology runs

The toxicology page states plainly that "the following toxicology services are offered by our parent company JOINN Laboratories,"^[S3] listing the parent's facilities in Suzhou, Beijing, Wuzhou, Chongqing and Guangzhou.^[S3] The parent states GLP status in several regimes, describing itself as inspected under US FDA GLP and certified or inspected under Chinese, OECD, Japanese and Korean regimes.^[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.^[S6] 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] For a US sponsor there are practical consequences beyond the regulation itself: before contracting, sponsors should document the test facility, the monitoring plan, the sample and data transfer process, the timeline, the applicable GLP regime and inspection responsibilities. None of that makes the arrangement unsuitable; it does mean the arrangement should be understood before contracting rather than discovered later.

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

Compliance statements differ by site. The Worcester, Massachusetts facility is listed with AAALAC accreditation, an OLAW Animal Welfare Assurance, USDA registration and a DEA registration.^[S5] The Richmond, California facility is listed with AAALAC, USDA and DEA but without an OLAW statement.^[S5] Whether that reflects a real difference or an omission on the page is not explained, and a sponsor whose work is funded by the Public Health Service would need to resolve it. 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 company's animal care program; the statements above are the company's own.

Company facts