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 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.
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