MuriGenics is a preclinical contract research organization in Vallejo, California, on the northeast side of San Francisco Bay.[S2] It describes itself as offering "robust preclinical in-vivo and in-vitro contract drug discovery and development services, supported with statistical validation, solid science and project management to companies throughout the United States."[S1] One characteristic is worth stating up front: the company describes its toxicology and biodistribution work as non-GLP in its own words, so sponsors needing GLP toxicology should ask whether another provider or arrangement is required.[S3][S4] This profile summarizes the models, services, stated compliance information, and company facts most relevant to US sponsors.
The oncology page lists xenograft, syngeneic, orthotopic, homograft, genetically engineered and metastatic mouse models, grouped as xenograft (cell line-derived), syngeneic, orthotopic, homograft and genetically engineered mouse models, and metastatic models.[S5] Hosts listed for xenograft work are "athymic Nude mice (Balb/c background Foxn1nu mutation), NSG, other immune-deficient mice."[S5] Named xenograft cell lines include LNCaP, PC-3 and DU-145 for prostate; MCF-7, BT-474, SK-BR3, BT-20, MDA-MB-231, MDA-MB-468 and MDA-MB-453 for breast; HT-29, HCT-116, COLO 205, SW620, SNU-C2B and KM12 for colorectal; and NCI-H460, NCI-H522, A549 and DMS53 for lung.[S5] Syngeneic lines listed include 4T1 and EMT-6, KLN205 and Lewis lung carcinoma, colon26, CT26 and MC38, A20 and EG7, B16 and Renca.[S5] For immuno-oncology the company offers adoptive transfer of peripheral blood mononuclear cells, cytotoxic T lymphocytes and natural killer cells, CAR-T evaluation and syngeneic checkpoint inhibitor work, noting that "CAR-T-cell therapy can induce rapid and durable clinical responses which are associated sometimes with acute toxicities."[S6]
Autoimmune models listed include insulin-dependent diabetes in non-obese diabetic mice, experimental autoimmune encephalomyelitis induced with MOG or PLP, collagen-induced arthritis and lupus models in BALB/c and B6 mice.[S7] Inflammation models cover LPS and carrageenan challenges, inflammatory bowel disease, sepsis and allotransplant designs, and organ fibrosis models include bleomycin-induced lung fibrosis, carbon tetrachloride-induced liver fibrosis, cisplatin-induced kidney fibrosis, methionine-choline-deficient diet-induced fibrosis and bleomycin-induced skin fibrosis.[S7] Other areas listed are metabolic disease with diet-induced obesity in C57BL/6 mice, db/db and ob/ob mice, the Zucker diabetic fatty rat and the Goto-Kakizaki rat; cardiovascular models in ApoE and LDL receptor knockout mice and the spontaneously hypertensive rat; MPTP-induced Parkinson's disease; and infectious disease models including a neutropenic thigh model and a superficial skin wound infection model.[S8]
In vitro services cover cytotoxicity and proliferation, apoptosis, cell cycle, migration and invasion, and hepatotoxicity panels, drawing on a bank the company describes as "over 200 banked cell lines."[S9] A myelotoxicity panel using colony-forming assays is offered, described as "a panel of screens designed to help our clients gain insight into the possibility to which their compounds may produce myelotoxicity."[S10] Gene function work includes transfection, siRNA and shRNA knockdown and "genome editing of individual and multiples genes ? including CRISPR_CAS9,"[S11] with RNA isolation, qPCR and RNA-seq. Immunoassays cover ELISA, bead-based multiplex cytokine panels, flow cytometry and ELISpot.[S13] Histology is performed on site and the company states that "our highly trained and experienced board-certified pathologist is committed to provide you with the highest level of quality,"[S12] covering standard and special stains, immunohistochemistry and immunofluorescence, tissue microarray and multiplex immunohistochemistry.[S12]
GLP. The company states directly that it "specializes in preclinical stage non-GLP toxicology studies"[S3] and that it "offers non-GLP services to accurately access the bio-distribution of test compound in the target and non-target tissues."[S4] These are explicit statements rather than an absence of information. GLP compliance attaches to individual nonclinical laboratory studies under the applicable regulation,[R2] so a program can combine exploratory work here with GLP studies at another facility, provided the roles are agreed in advance. The site does not address whether GLP work is ever arranged through a partner laboratory.
Animal oversight. The company states that "at MuriGenics we have established IACUC protocols for toxicology studies in mouse and rat species,"[S3] that "our rodent protocols are IACUC approved,"[S4] and that irritation studies are "conducted in accordance with the approved IACUC protocol and OECD guidelines 404 for acute dermal irritation/corrosion."[S3] No AAALAC accreditation, USDA registration or OLAW Animal Welfare Assurance statement was found on any of the pages reviewed, and the 3Rs terminology is not used. That is an absence in those pages, not a finding about the status of the company, since the company does state its IACUC arrangements. Sponsors who require accreditation or registration documentation should ask the company directly. 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]
| Name | MuriGenics (no corporate suffix is shown on the website)[S1] |
|---|---|
| Location | Vallejo, California, United States (no street address is published)[S2] |
| Founded | Not stated on the pages reviewed |
| Ownership | Not published |
| Leadership | Henry Lopez (President and Chief Scientific Officer); Steven Noonan (Chief Operations Officer)[S1] |
| Scientific advisors | Nine named consultants covering pathology, laboratory animal medicine, molecular and cell biology, biochemistry, pharmacology, medicinal and organic chemistry, and formulation[S1] |
| Employees and facility size | Not published |
| Species | Mice (outbred, inbred and genetically engineered strains) and rats, with implanted catheters available[S3] |
| GLP | The company describes its toxicology and biodistribution work as non-GLP[S3][S4] |
| Animal oversight | IACUC-approved rodent protocols; OECD Test Guideline 404 named for dermal irritation. No AAALAC, USDA or OLAW statement found[S3] |
| Cell line bank | More than 200 banked cell lines[S9] |
| Phone | +1 (707) 561-8900[S2] |
| Website | www.murigenics.com |
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.