Non-GLP Toxicology

Gain certainty over the toxicology profile of your agent 

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"CrownBio brings clarity to drug discovery around the world by helping biopharmaceutical companies solve some of today's most pressing problems in oncology, cardiovascular, and metabolic disease.

Leveraging our industry expertise, CrownBio's global resources help customers answer the most challenging questions about human biology. We begin with the end insight to help you achieve your goals"

Dr Jean-Pierre Wery
CEO, Crown Bioscience Inc.

Move with Confidence to Regulatory Submission with CrownBio Non-GLP Toxicology Studies

CrownBio provides Non-GLP Toxicology studies in NHPs and rodent models to provide robust, high quality data, and to allow clients the maximum confidence with regulatory submissions.

Non-GLP Toxicology Studies in NHPs

Using NHP models, CrownBio evaluates agents through a comprehensive assay platform, testing drug physiological and pathological effects. Studies can be rapidly initiated within 2 weeks (dependent on test article availability), with study duration optimized to fit client and project needs.

CrownBio provides healthy NHPs for toxicology studies, as well as our unique collections of spontaneously diabetic, dysmetabolic, and obese NHPs which can provide specific information if a client’s test article(s) is targeted to treat one specific disease.

We offer a range of common agent delivery routes including:

  • Intravenous injection or infusion
  • Intramuscular injection
  • Subcutaneous injection
  • Oral routes – via diet or gavage.

As well as having expertise in additional routes such as intraperitoneal injection and intrathecal administration.

Following administration, our comprehensive assessments include tissue and organ collection, as well as a host of assays and parameter collections.

Tissue and Organ Collection

Assays and Parameter Collection

Blood and other bodily fluid collection

Clinical observation

Biopsy of liver, kidney, fat, muscle, skin etc. to fit client needs

Body weight, food/water consumption

Gross necropsy (sample number to fit client needs):

  • Morphology observation/weight
  • Organ/tissue collection
  • Organ/tissue fixation with 10% formalin, 4% formaldehyde
  • OCT cryopreservation
  • Liquid nitrogen (snap freezing for RNA)
  • Etc.

Blood CBC, PBMC, cell sorting, and chemistry

Blood pressure, ECG, glucose monitoring (including continuous monitoring)

Hematology and bleeding tests

Bone marrow slides and reading

Urine assay

Histology/IHC

Slide section reading

Non-GLP Toxicology Studies in Rodent Models

Our toxicology assays can be performed in any commercially available rodent model, or in our proprietary highly translatable models of Type 2 diabetes (FATZO mouse, ZDSD rat) or genetically-relevant models of Polycystic Kidney Disease (jck and pcy mice, PCK rat) for enhanced studies.

Our main Non-GLP Toxicology capabilities in rodents include:

  • Necropsy
  • Gross organ weights
  • Fixation for histology or rtPCR
    • 10% buffered formalin
    • OCT cryopreservation
    • RNAlater®

CrownBio provides a wealth of experience in Non-GLP Toxicology and Safety Pharmacology studies, contact us today for expert opinion and advice on your project needs.