BioAgilytix Labs, Inc. is a bioanalytical laboratory headquartered in the Research Triangle area of North Carolina. It describes its offering as "global pharmacokinetic (PK), immunogenicity, biomarker, and CMC analytical services in a GxP environment."[S1] The cited pages describe bioanalytical services and do not describe animal studies.[S1][S4] Sponsors should confirm separately who will conduct any in-life animal phase and how samples will be transferred for analysis. The company does not publish a founding year, saying only that it began "nearly thirty years ago."[S2] This profile summarizes the services, sites, stated compliance information, and company facts most relevant to US sponsors.
Services relevant to US drug developers
Pharmacokinetics, immunogenicity, and biomarkers
The solutions page lists drug metabolism, pharmacokinetic services, pharmacodynamics, immunogenicity, biomarkers and diagnostic testing as the service lines.[S4] Biomarker work is described as enabling a sponsor to "assess a therapeutic's efficacy, safety, and mechanism of action,"[S6] with more than 120 off-the-shelf assays available and platforms including ELISA, MSD electrochemiluminescence, Gyrolab, Luminex, Protein Simple Ella, LI-COR Odyssey, qPCR, ddPCR and HPLC.[S6] All of this is in vitro analysis of samples; the company does not describe in vivo studies, toxicology dosing, safety pharmacology or pathology services.
Cell and gene therapy bioanalysis
For advanced therapy medicinal products the company covers cell therapy, CAR cell therapy, gene therapy, RNA-based and oligonucleotide therapies and stem cell therapy, noting that "each of these modalities requires a unique strategy for bioanalytical support."[S5] Named assays include cellular immunogenicity, cellular kinetics, immune phenotyping, cytokine analysis and cytokine release syndrome monitoring, vector and transgene anti-drug antibodies, vector copy number, viral shedding and distribution, and replication competent virus testing.[S5] These assays can support a biodistribution or toxicology program; sponsors should confirm who will conduct the in-life work and how samples and data will be transferred.
Quality and compliance (as stated by the company)
GLP and other quality systems. The quality page states that "our labs operate in accordance with 21 CFR Part 58 and our European lab is GLP certified,"[S7] that "our Durham laboratory is additionally able to offer services under GMP,"[S7] and that "our labs in Boston, MA and Durham, NC are also CLIA certified to perform lab-developed tests that are subject to CLIA oversight."[S7] The company names FDA 21 CFR Part 58 in its GLP statement.[S7] 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] Note that the GLP certification statement is specific to the European laboratory in Hamburg, while the US laboratories are described as operating in accordance with the regulation. The cited page does not identify the certifying authority or the applicable GLP regime for the Hamburg statement, and sponsors should obtain the certificate itself.[S7] No AAALAC, USDA or OLAW statement appears, which is consistent with a laboratory that does not house research animals.
Regulatory milestone. In February 2026 the company announced that its Anti-AAV Antibody Assay received FDA Breakthrough Device Designation.[S8] Breakthrough Device Designation is a program that provides interactive review and priority engagement for a device during development; it is not a marketing authorization, and a designated device still requires the applicable FDA marketing submission before it can be sold.
Sites
The locations page lists laboratories in Durham, North Carolina (about 89,109 square feet); Morrisville, North Carolina (196,000 square feet across two buildings); Boston, Massachusetts (22,205 square feet); San Diego, California (34,000 square feet); Hamburg, Germany, described as the European hub (3,222 square metres); and, operating as "360biolabs, a BioAgilytix Company," Melbourne (3,000 square metres) and Brisbane (150 square metres) in Australia.[S3] The homepage additionally shows a partner-lab presence in Beijing.[S1] Street addresses are loaded dynamically on that page and could not be read from the page source.
Durham and Morrisville, North Carolina, United States (street address not published on the pages reviewed)[S3]
Founded
Not stated; the company says it began "nearly thirty years ago"[S2]
Ownership
Private. The investment firm Cinven states on its own portfolio page that it holds a majority investment made in December 2021; no ownership statement was found on the company website[S9]
Durham and Morrisville NC; Boston MA; San Diego CA; Hamburg, Germany; Melbourne and Brisbane, Australia (as 360biolabs)[S3]
Service scope
Bioanalytical: PK, immunogenicity, biomarkers, cell and gene therapy bioanalysis, CMC analytical[S4][S5]. No in-life, toxicology dosing, safety pharmacology or pathology service was found on the pages reviewed; confirm separately
Labs operate in accordance with 21 CFR Part 58; the Hamburg laboratory is GLP certified; Durham additionally offers GMP; Boston and Durham are CLIA certified[S7]
Client base (company statement)
Bioanalysis delivered to 21 of the top-25 global pharmaceutical and biotechnology companies[S2]
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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