Noble Life Sciences Preclinical Development Services for the Pharmaceutical Industry
Noble Life Sciences is a full service preclinical contract research organisation (CRO) for drugs, vaccines and medical devices.
The company supports research and development (R&D) programmes by providing good laboratory practice (GLP) and non-GLP services, including in-vivo and in-vitro specialised models. Available services include pharmacology, disease models, safety assessments, toxicology, custom polyclonal antibodies, cell line development and analytical testing.
Noble Life Sciences also provides high-quality animal services that meet the requirements of the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) accreditation and the Office of Laboratory Animal Welfare (OLAW). The company holds a US Department of Agriculture (USDA) licence and has more than 50 years of experience in animal housing and husbandry.
Oncology drug evaluation services for small molecule and biologic anticancer therapeutics
Noble Life Sciences provides a variety of animal models for the characterisation of oncology drugs.
Testing for elements such as efficacy, pharmacodynamics (PD), toxicity and bioavailability, the company’s models include xenograft, breast adenocarcinoma, orthotopic and ectopic, metastatic, leukaemia, immuno-oncology, cell therapy and humanised mouse models.
Cell line panel for cancer drug screening
Noble Life Sciences screens drug candidates using OncoDiversity Cell Line Panel, which comprises a wide range of cell lines for various cancer indications.
The software identifies correlating molecular biomarkers in cell lines, which are confirmed using the company’s biobank resource of DNA and protein samples. Validation of the drug and biomarker response is then carried out in in-vivo cell models.
Noble Life Sciences’ method provides clients with an understanding of the expression status of the target and molecular pathways, as well as determines active plasma concentrations, modulates downstream pathways and assesses the therapeutic index. The company delivers high-quality data that comprises examinations of a broad range of validated DNA and protein-based biomarkers.
Pharmacodynamic models and cancer model options
Noble Life Sciences establishes PD biomarkers that link drug activity affecting the molecular target with downstream signalling pathway effects. The results help determine optimal doses and schedule requirements for clinical trials.
The company also offers transgenic and surgically modified animal models to assess compounds using log-10 cell kill (LCK), survival, combination or adjuvant approaches. Characteristics that can be assessed include tumour growth delay and inhibition using live animal imaging, drug potency, apoptosis, cell cycles, pathway interrogation and flow cytometry-based immunophenotyping and cytokine analysis and next-generation sequencing (NGS)
Biomarker discovery screening, therapeutic combinations analysis and tumour antigen testing are also available.
Animal disease models for developing novel therapeutics
Noble Life Sciences aims to meet the growing demand for novel anti-microbial therapeutics, which are used to address issues such as the increasing number of multi-drug-resistant infectious agents caused by the overuse of antibiotics.
The company is experienced in using animal models for efficacy studies that explore toxicity and validate biomarkers. It utilises a panel of optimised animal models to screen new antiviral and antibacterial agents for the development of anti-infectious drugs. This results in in-vivo physiological measurements and quantified infectious agents that can be coupled with pharmacokinetics (PK) and PD analysis.
Noble Life Sciences offers the following disease models:
- Viral infection models, including human respiratory syncytial virus (RSV) and influenza cotton rat models
- Bacterial infection models, including neutropenic thigh models and sepsis and lung infection models
- Inflammatory disease models
- Immunogenicity models
- Diabetes wound infection models
- Surgical site infection models
The firm also works with clients’ drug discovery teams to access new models of infection.
Animal disease model optimisation
Noble Life Sciences optimises animal disease models to meet client requirements, including oral gavage, continuous infusion, and dietary admixture, as well as dermal, intravenous, subcutaneous, intradermal, intramuscular, intraperitoneal and intranasal.
Vaccine development services
Noble Life Sciences has more than 15 years’ experience managing vaccine development trials.
The company provides GLP and non-GLP, in-vivo and in-vitro services, including immunogenicity tests, influenza challenge studies, efficacy studies and bio-distribution studies for a wide variety of mammalian species. The trials range from single-animal studies to larger trials comprising hundreds of animals.
Noble Life Sciences supports a wide range of GLP process in preparation for investigational new drug (IND), investigational device exemption (IDE), premarket approval (PMA) or US Food and Drug Administration (FDA) submissions.
Surgical adhesion models service
Noble Life Sciences’ rabbit abdominal sidewall adhesion model is a reproducible and flexible model for evaluating the adhesion properties of materials. Various testing methods can be used with the model, including laparoscopic procedures.
Applications of the adhesion model include efficacy testing of raw materials, comparing the adhesion efficacy of products with new materials, and evaluating surgical methods intended to prevent adhesion formation.
Also available in rats, the model provides results in around 32 days and includes measurements such as body weight, tensiometry and histopathology.
Drug pharmacology and exploratory toxicology activity
Noble Life Sciences performs pharmacokinetic and PD drug testing and modelling, including candidate selection, safety evaluations and patient dosing strategies. Utilising a large collection of reference compounds for comparator studies, the firm identifies dosing routes, conducts dose range finding studies and finds the maximum tolerated dose.
The company also examines the toxicology of drugs in studies such as sensitisation, irritancy, dermal, and repeat dose types, as well as acute, sub-chronic and chronic toxicology.
Custom polyclonal antibody production services
Noble Life Sciences provides GLP and non-GLP custom polyclonal antibody services using a wide variety of models, including mice, rabbits, guinea pigs, ferrets, sheep and goats. The company provides conjugation, titre analysis via enzyme-linked immunosorbent assays (ELISA) and antibody purification, as well as peptide sequence analysis and synthesis.
The firm also performs immunogenicity and efficacy studies in mice, rats, ginea pigs and rabbits.
Analytical and laboratory services
Noble Life Sciences provides analytical and laboratory services, including gene-expression, clinical pathology and customised assays.
It also supplies cell-based assays, including cell cytotoxicity, apoptosis, viability, transmigration, proliferation, wound healing and cell line screening assays.
Noble Life Science has expertise in designing high-throughput gene expression microarrays and quantitive polymerase chain reaction (qPCR), as well as monitoring biomarker expression in animal models and tracking gene panel and pathway markers.
Noble Life Sciences provides an array of imaging solutions, including:
- Live animal imaging with the Perkin Elmer IVIS system, which uses bioluminescent or fluorescent reporters
- C-arm imaging scanner intensifier with radiographic capabilities for animal model imaging
- Computed tomography (CT) 32 and 64-slice
- Magnetic resonance imaging (MRI) 1.5T and 3T scanners