Ichor Life Sciences, Inc. describes itself as "a pre-clinical contract research organization (CRO) with 100% US operations."[S1] It runs a discovery laboratory in Syracuse, New York and a separate vivarium in LaFayette, New York.[S3] The company states that it was founded by Kelsey Moody while in medical school at SUNY Upstate Medical University, with its timeline placing the founding in May 2013.[S2] One point is worth stating up front: the company says on its toxicology page that it is "not currently providing GLP studies."[S4] Sponsors who need a GLP safety study for a regulatory submission should plan to place that work elsewhere. This profile summarizes the services, facilities, stated compliance information, and company facts most relevant to US sponsors.
The in vivo model catalog spans oncology and immuno-oncology, ophthalmology, aging and lifespan, metabolic disease, wound healing, cardiovascular disease and custom model development.[S5] In oncology the company offers syngeneic, orthotopic and cell line-derived xenograft models, stating that it offers "a wide variety of profiled syngeneic mouse models that provide a more approachable method of immunology than typical xenograft modelling."[S6] Ophthalmology is described as the company's original focus: "spanning anterior to posterior disease models, we can assist! Our core business has been rooted in ophthalmic pharmacology for over 10-years,"[S7] with named models including glaucoma, experimental autoimmune uveitis, endotoxin-induced uveitis, wet and dry age-related macular degeneration, a Stargardt disease model, laser-induced choroidal neovascularization, optic nerve crush and ocular hypertension.[S7] For aging research the company states that "pre-aged C57BL/6 and HET3 mice are readily available."[S8]
The company states: "Although not currently providing GLP studies, Ichor Life Sciences has partnered with numerous clients in providing exploratory and nonGLP carcinogenicity studies."[S4] Listed study types are acute toxicity and maximum tolerated dose, single and repeat-dose range finding, carcinogenicity, chronic and subchronic toxicity, ocular toxicity, PK and TK studies, dose-range-finding embryo-fetal development studies, LD50 designs and dose-range-finding juvenile toxicity.[S4] Species listed are mouse, rat, rabbit and swine.[S4] Because these are exploratory rather than GLP studies, sponsors should agree in the protocol how the data will be documented and what role it will play in a later regulatory package.
The company offers PK and PD studies, stating that sponsors can "evaluate pharmacokinetics and pharmacodynamics at all phases of development with ELISAs for biologics, spectral flow cytometry for cell-based therapies, and mass spectrometry for small molecule,"[S9] alongside ADME assays for kinetic solubility, cytotoxicity and hepatotoxicity, lipophilicity and permeability.[S9] Its LC-MS services are described as "a comprehensive suite of capabilities including method development, quantitative bioanalysis, and pharmacokinetic profiling."[S10] A separate protein services group covers protein expression in bacterial, insect and mammalian systems, structural biology and x-ray crystallography, and biophysical assays including surface plasmon resonance, circular dichroism, nanoDSF, bio-layer interferometry and isothermal titration calorimetry.[S12] Histology is run as an in-house core described as "a full service facility featuring start of the art equipment with the capacity to process, embed, section, stain, and analyze tissue specimens,"[S11] covering standard stains, immunohistochemistry, immunofluorescence, quantitative image analysis and digitized slides.[S11]
GLP. The company states that it is not currently providing GLP studies.[S4] This is an explicit statement rather than an absence of information, and sponsors seeking GLP toxicology should treat that statement as a constraint on what can be placed here. GLP compliance applies to individual nonclinical laboratory studies under the applicable regulation,[R2] so a program can mix exploratory work here with GLP studies at another facility, provided the roles are set out in advance.
Accreditation and animal welfare. The company states that "our vivarium [is] an AAALAC accredited facility with an in-house IACUC"[S4] and, on its consulting page, that its attending veterinarian "has led our facility in AAALAC accreditation."[S14] An accreditation date is not published. No company-level USDA registration or OLAW Animal Welfare Assurance statement was found on the pages reviewed; USDA, OLAW, IACUC and AAALAC appear elsewhere only in the description of the attending veterinarian's prior policy work.[S13] The company also states that its "facilities prioritized animal welfare by promoting species-specific behaviors with enrichment activities."[S5] 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.
| Legal name | Ichor Life Sciences, Inc.[S3] |
|---|---|
| Headquarters | 831 James Street, Syracuse, NY 13203, United States[S3] |
| Vivarium | 2561 US Route 11, LaFayette, NY 13084[S3] |
| Founded | May 2013, by Kelsey Moody[S2] |
| Former name | Ichor Therapeutics; renamed Ichor Life Sciences in July 2021 to emphasize its service business[S2] |
| Acquisitions | Finger Lakes Bio (February 2017); Woodland Biosciences, Inc. (August 2020)[S2] |
| Ownership | No public-market listing is shown; the company states that its founder has raised over $30 million in venture capital since 2013[S13] |
| Staff | Headcount not published |
| GLP | The company states that it is not currently providing GLP studies[S4] |
| Accreditation | The vivarium is described as AAALAC accredited with an in-house IACUC; no date is published[S4] |
| Species | Mouse, rat, rabbit, swine[S4] |
| Focus areas | Ophthalmology, oncology and immuno-oncology, aging and lifespan, metabolic disease, wound healing, cardiovascular[S5][S7] |
| Website | ichorlifesciences.com |
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.
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.
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 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.
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.
Charles River provides non-clinical toxicology and safety assessment services for programs ranging from exploratory safety studies to IND-enabling development.
Services include single- and repeat-dose toxicology, dose-range finding, and general toxicology studies across multiple species and administration routes.
Charles River supports both non-GLP and GLP studies, allowing sponsors to progress from early safety characterization to studies intended for regulatory submissions.
Toxicology studies can be integrated with toxicokinetics, clinical pathology, histopathology, and safety pharmacology to support interpretation and IND-enabling safety packages.
Inotiv provides integrated PK/PD, DMPK, and bioanalytical services to characterize drug exposure and its relationship with pharmacological response.
PK studies characterize exposure, half-life, clearance, and other pharmacokinetic parameters needed to understand how a candidate behaves in the selected model.
Pharmacokinetic data can be combined with pharmacodynamic endpoints and bioanalysis to evaluate the relationship between drug exposure and pharmacological response.
Integrated DMPK, pharmacology, and safety information supports candidate comparison, dose selection, dosing-frequency optimization, and decisions about subsequent preclinical development.