BioDuro LLC

BioDuro is a contract research, development and manufacturing organization headquartered in Irvine, California.^[S1][S2] The location of the work is the first thing a United States sponsor needs to know, and the company own site page states it plainly. Of the sites listed, the American one is described as headquarters, project management and international shipping and logistics.^[S2] Discovery biology, drug metabolism, in vivo pharmacology, chemistry and manufacturing are listed at six sites in mainland China and at a joint venture in Taiwan.^[S2] A drug product manufacturing facility in Irvine was sold in January 2026, after which the company stated that its drug product team is based in China.^[S8] None of that is hidden; it is taken directly from the company own pages. But it means a sponsor placing work here is placing it offshore, while the cited pages place the laboratory, animal and manufacturing work at sites in China and Taiwan.

Services relevant to US drug developers

Discovery, DMPK and in vivo pharmacology

The discovery offering spans medicinal and process chemistry, discovery biology, monoclonal antibody discovery, drug metabolism and pharmacokinetics, and in vivo pharmacology, distributed across the China sites.^[S2] In vivo pharmacokinetic and toxicokinetic studies are described in rodents and non-rodents, covering multiple routes, cassette dosing and surgical cannulation, alongside maximum tolerated dose work, dose range finding with toxicokinetics over seven, fourteen and twenty-eight days, pharmacokinetic and pharmacodynamic evaluation, blood-brain barrier studies and drug-drug interaction work.^[S3] The company states that these studies are designed to meet both United States and Chinese regulatory standards.^[S3] Patient-derived xenograft models are offered for oncology programmes, though the model count is given inconsistently on the page itself, so no figure is reproduced here.^[S4]

Chemistry and manufacturing

Chemistry capacity is spread across sites: scale-up chemistry in the Shanghai free trade zone, process chemistry with kilogram-scale laboratories under both current good manufacturing practice and non-regulated conditions in the Shanghai high technology park, intermediates and starting materials in Anhui, and a specialized chemistry site in Hebei.^[S2] Active pharmaceutical ingredient manufacture under good manufacturing practice is listed at the Taiwan joint venture, and a second Taiwan joint venture for commercial-scale ingredient manufacture was announced in March 2026, described as capacity outside mainland China.^[S2] For a sponsor weighing supply chain concentration, the Taiwan arrangements are the part of the footprint that changes the picture.

GLP toxicology: performed by a partner

The company announced a partnership in April 2026 under which its own contribution is discovery chemistry, biology, drug metabolism and pharmacology, while good laboratory practice toxicology studies and bioanalysis for an investigational new drug submission are contributed by the partner company, based in Suzhou, China.^[S5] That is a material distinction for a sponsor choosing where to place a regulatory safety package: sponsors should confirm which legal entity will be the test facility, which quality system will apply, and who will act as study director.^[R2] An older announcement, from June 2016, described good laboratory practice research among the capabilities of the Shanghai site.^[S6] Whether that reflects a change in capability or only a change in how the work is described could not be determined from the pages reviewed, so both statements are given with their dates. A sponsor should ask directly which legal entity would hold the study and issue the compliance statement.

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

AAALAC accreditation is stated for the company vivariums, without naming which site holds it.^[S4] Since no in vivo capability is listed at the United States site, the accredited facility is presumably in China, but the pages reviewed do not say so and this profile does not assert it. No United States Department of Agriculture registration, Animal Welfare Assurance or institutional animal committee statement was found; the applicability of those frameworks depends on the study site, the species, the funding source and the institutional arrangements, and should be assessed for the specific study, and the site describes none.^[S2] 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] Two certifications that appear on the site belong to other categories entirely: an information security standard held by two China sites, and a business sustainability rating held by three China sites.^[S10][S11] Neither speaks to laboratory quality or animal welfare, and they should not be read as if they did.

Corporate history, ownership, and naming

The company has changed hands and names repeatedly, which matters mainly because older references and current ones may not appear to describe the same organization. Its own history records acquisition by a large clinical research organization in 2009, reacquisition and a merger in 2015, a majority investment by the private equity firm Advent International in 2019, and a merger with Sundia in 2020, after which it traded as BioDuro-Sundia.^{[S1][S7][S12]} By September 2024 announcements had reverted to BioDuro alone.^[S9] Founding year is given two ways: current materials date the business to 1996 through a predecessor company, while the history page and a 2016 announcement date BioDuro itself to 2005 in San Diego.^{[S1][S6][S10]} Company materials reviewed on September 3, 2026 gave conflicting headcount and site-count figures^{[S1][S2][S10]}, so none of those figures is reproduced here. Chief executives have changed several times, most recently in September 2024.^[S9]

Company facts