Cell and Gene Therapy

Toxicology

GLP and non-GLP preclinical contract services to help you get from concept to clinic faster and more efficiently. You can trust Noble scientists to help lead and support your drug development programs through each phase of the preclinical process.

Let Noble Life Sciences’ unparalleled expertise and state-of-the-art facilities be your trusted partner for all of your preclinical biodistribution and shedding studies. We have worked with xx organizations to bring xx new therapies to market.

Your preclinical development partner

Program development and implementation

With over 25 years of proven experience in vaccine and drug development, Noble’s scientists can manage your drug development programs through each phase of the preclinical process, from design and implementation to regulatory support of your IND, IDE or PMA FDA submission.

With our state-of-the-art, FDA-inspected GLP facilities, an extensive set of standard operating procedures, and an experienced team, Noble can help you get from concept to the clinic faster and more efficiently.

We can guide you through your preclinical testing or turn the entire project over to us and we will handle all aspects from protocol to final report.

Operations

  • FDA-inspected GLP facility
  • Standard operating procedures that cover all aspects of animal care, animal procedures, equipment and facility operations

Operate in accordance with
USDA and OLAW logos
Fully accredited by

Drug Activity

Our studies are designed and run by seasoned experts.

Services include:

  • Pharmacokinetic & pharmacodynamic drug testing
  • Pharmacodynamic modeling for candidate selection, safety evaluation and patient dosing strategies

We can also:

  • Identify appropriate dosing routes
  • Conduct dose range finding studies
  • Perform studies to establish the maximum tolerated dose

We have a large collection of reference compounds for comparator studies.

Drug Formulation

If you need assistance with drug candidate pre-formulation and formulation development, Noble scientists will apply their expertise to address your needs.

Exploratory Toxicology

Noble scientists will work with you to examine the toxicology of your drug candidate as part of your development program.

Studies types include:

  • Acute, subchronic, & chronic toxicology
  • Sensitization
  • Irritancy
  • Dermal
  • Repeat dose

GLP Toxicology Services

Toxicology studies are required to determine the adverse effects of drug candidates and the effect of dosage on toxicity. To assess toxicity, Noble offers a wide range of GLP and non-GLP toxicology services.

  • Exploratory Toxicology
  • General Toxicology
  • Immunotoxicology and Immunogenicity
  • Development and Reproductive Toxicology
  • Toxicokinetics

In addition to GLP toxicology services, Noble Life Sciences provides all aspects of the GLP process from design to regulatory support of your IND, IDE or PMA FDA submission.

Capabilities

Services Options

  • Dose range finding
  • Single and repeat dose
  • Acute, subchronic and chronic
  • Local tolerance
  • Biodistribution
  • Ocular and skin irritation
  • Irritation evaluations
  • Median Lethal Dose (LD50)
  • Maximum Tolerated Dose (MTD)
  • No Observable Effect Level (NOEL)/No
    Observable Adverse Effect Level (NOAEL)

Routes of Administration

We offer a variety of drug administration options including:

  • Capsule
  • Continuous infusion
  • Dermal
  • Dietary admixture
  • Intradermal
  • Intranasal
  • Intraperitoneal
  • Intravenous
  • Oral gavage
  • Subcutaneous

Species Options

We offer a variety of species options including:

  • Mice
  • Rats, Cotton Rats
  • Ferrets
  • Guinea pigs
  • Hamsters
  • Sheep
  • Goats
  • Rabbits
  • Domestic swine
  • Mini pigs

Toxicology Services

Download our GLP Toxicology Capabilities Sheet and share it with your team today. 

Toxicology Studies

Vaccine Development Services:

  • Single-dose acute and repeat-dose studies
  • Biodistribution studies
  • Clinical observations; complete clinical chemistry and pathology package

Toxicology Team

Scientists with over 15 years of GLP experience

Quality assurance professionals with over 25 years of experience in the industry, including board-certified veterinarians, PhD and Master level scientists, as well as AALAS-certified technicians and technologists.

Stephen K. Horrigan, Ph.D.

Stephen K. Horrigan, Ph.D.

Chief Scientific Officer

We are proud of our ability to successfully customize studies and develop unique procedures to facilitate the research and development of your product.

Resources & White Papers

PASSIONATE ABOUT COLLABORATING FOR A CURE