Smithers describes itself as "a multinational provider of testing, consulting, information, and compliance services"[S1] and traces its founding to a three-bay garage in Akron, Ohio in 1925.[S2] For drug developers the important point is what it does today. In May 2019 it divested its in vivo toxicology business in Gaithersburg, Maryland, which covered "general toxicology, vaccine safety and developmental and reproductive toxicology (DART)," to Bioanalytical Systems, Inc.[S3] That sale explicitly excluded the large molecule bioanalytical business, which continues.[S3] No current in vivo service line or animal facility statement was found on the pages reviewed; that is an absence in those pages, not a finding that Smithers does not conduct such work. The reviewed pages describe bioanalytical and analytical testing.
Services relevant to US drug developers
Large-molecule bioanalysis and immunogenicity
The pharmaceutical business is built on large-molecule bioanalysis. The company states that "our expert scientists perform large molecule bioanalysis, assay development, validation, and sample analysis at our GLP- and GCP-compliant laboratories,"[S4] covering pharmacokinetic and toxicokinetic bioanalysis, anti-drug antibody testing, neutralizing antibody assays, fit-for-purpose biomarker assays, immunogenicity risk assessment, and qPCR and ddPCR transcriptional biomarker work.[S4][S5] Platforms named for ligand binding assays are "ELISA (single analyte), Meso Scale Discovery (single and multiplex), GyroLab (sample size), Quanterix (ultra sensitive)."[S6] Biomarker platforms additionally include Singulex ERENNA and Alpha-LISA, covering oncology, neurology, autoimmune and metabolic markers as well as cytokines and interferons.[S7] Cell-based assays are used within immunogenicity work for "functional assessments for neutralization and potency."[S5]
Extractables and leachables, environmental risk assessment, and device testing
Outside bioanalysis the company offers extractables and leachables chemistry for packaging, single-use technologies and combination products, stating that its experts deliver these assessments "in our FDA registered laboratories."[S4] It also provides environmental risk assessment consulting, noting that "the EMA requires that an Environmental Risk Assessment (ERA) accompany every Marketing Authorization Application (MAA) for a new pharmaceutical,"[S4] covering aquatic and terrestrial ecotoxicology, environmental fate and residues. Its medical device division tests devices, drug delivery devices and healthcare packaging at GMP facilities, with a European laboratory in Frankfurt described as providing "expert testing for medical device and pharmaceutical manufacturers across Europe and the rest of the world."[S12]
Quality and compliance (as stated by the company)
GLP, GCLP, and CLIA. The company states that it "operates GLP-compliant, CLIA-certified laboratories in Gaithersburg, Maryland and Ewing, New Jersey"[S5] and offers "support for GCLP and CLIA-regulated studies in human matrices."[S5] CLIA certification of the New Jersey laboratory was announced in July 2020 as "a certification of compliance from the Clinical Laboratory Improvement Amendments (CLIA) program regulated by the Centers for Medicare and Medicaid Services (CMS)."[S9] 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.[S5] 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 also that the accreditations page labels the pharmaceutical division "GCP-Compliant"[S8] while the service page uses GCLP;[S5] the two terms are not identical and both appear on current company pages. Regulation names are given only for the separate environmental risk sciences sites: OECD GLP at Harrogate in the United Kingdom and GLP under US EPA and US FDA at Wareham, Massachusetts.[S8]
No AAALAC, USDA, OLAW, IACUC or 3Rs statement was found on the pages reviewed; that is an absence in those pages, not a finding about the status of the company. No AAALAC accreditation, USDA registration, OLAW Animal Welfare Assurance, IACUC or 3Rs statement was found on the roughly twenty pages reviewed, including every pharmaceutical and bioanalytical page. The bioanalytical pages do refer to mouse and cynomolgus monkey serum and to human cerebrospinal fluid, synovial fluid and vitreous humor, but these are sample matrices submitted for analysis, not animals housed or dosed by the company.[S7]
3637 Ridgewood Road, Fairlawn, Ohio 44333, United States. Press releases describe the company as headquartered in Akron, Ohio, an adjacent city[S1][S3]
Described on the site as independent; no stock ticker, exchange listing or named parent was found[S3]
Employees and revenue
Not published
Global footprint
24 facilities across North America, Europe and Asia[S10]
US pharmaceutical laboratories
Gaithersburg, Maryland and Ewing, New Jersey, both described by Smithers as GLP-compliant and CLIA-certified, without the applicable GLP regulation being identified[S5]
Pharmaceutical service scope
Large molecule bioanalysis, immunogenicity, biomarkers, molecular biology; extractables and leachables; environmental risk assessment; medical device and packaging testing[S4]
In vivo animal work
None described on the current site. The Gaithersburg in vivo toxicology unit was divested to Bioanalytical Systems, Inc. in May 2019, excluding the bioanalytical business[S3]
Quality statements
US pharmaceutical laboratories that Smithers describes as GLP-compliant and CLIA-certified; GCLP support for human matrix studies; the accreditations page labels the division GCP-Compliant[S5][S8]
Other accreditations
ISO 17025 for materials science and medical device sites; GMP FDA facility registrations for Akron, OH and Shawbury, UK[S8]
Other restructuring
Avian testing discontinued and the Snow Camp, North Carolina facility decommissioned in July 2022[S11]
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.
Japanese
