Register

Company Profile

Sourcing Inquiry Logo ATRC Aurigon Toxicological Research Center

ATRC Aurigon Toxicological Research Center

Regions
Europe
Countries
Hungary
Size
50-100
Specialty
Human Medicines, Biopharmaceuticals, …
Specialty
Human Medicines, Biopharmaceuticals, Generics, Animal Medicines, Medical Devices
Service category
Pre-clinical development and testing, pre-clinical CRO, Analytical laboratory and testing services
Content posted and uploaded by users. Want to add your company?
Your company? Get access to this profile.

Summary

ATRC Aurigon Toxicological Research Center Ltd. is a full-service non-clinical CRO with offices in Munich , Germany and GLP/GMP sites in Budapest , Hungary.
Our company provides in-life and bioanalytical services for the life science industry most notably to pharmaceutical companies. We offer various types of in vivo and in vitro studies including, but not limited to PK/PDADME, toxicology and safety pharmacology in several species from mouse to sheep. The studies are performed by highly qualified staff with up to 30 years of experience in purpose-built facilities and with the use of modern equipment and instruments. 
 

Our most fundamental advantage – beyond our expertise – is our attitude: we providetailor‑made studies optimized for your goals in order to maximize our added value to your project.


A brief overview of our comprehensive range of services:

 

Wide range of pharmaceutical / healthcare categories

  • New Chemical Entities (NCE)
  • Generics
  • Herbal Medicinal Products
  • Food / Food Ingredients
  • New Biological Entities (NBE)
  • Biosimilars / Biobetters
  • Vaccines / Immunotherapies
  • Cell-Based Therapies (ATMPs)
  • Medical Devices

Bioanalytics

  • Quick method development / method transfer for small molecules, peptides, proteins (including antibodies)
  • Most appropriate techniques (LC-MS/MS, HPLC-UV, ELISA, Triple quad, Ion-trap, Flow-cytometry, Luminex, FACS, RIA, Radiometry: 14C, 3H, 125I, 32P, liquid scintillation and γ-counters, TopCount and online LC radioactivity detectors)
  • Method validation according to latest FDA, EMA and ICH guidelines
  • Stability testing in formulation and different matrices
  • Bioanalytical support of both clinical and non-clinical studies

ADME/PK

  • Pharmacokinetic and bioavailability studies in rodents, non-rodents andhumans
  • Tissue-distribution, protein-binding and excretion balance studies
  • Toxicokinetics in toxicity and safety pharmacology studies
  • In vitro and in vivo metabolism studies with profiling and metabolite identification
  • Biopharmaceutical assessment (pre-formulation and formulation studies)
  • PK, TK and statistical evaluation with acknowledged and validated tools
  • First-in-man dose prediction
  • Dosimetry calculation for human metabolism study

Preclinical Safety and Toxicology

  • Identification of the Most Human-Like Species
  •      In Vitro Metabolism
  •      Tissue Cross-Reactivity (TCR)
  • General Toxicity
  •      Genotoxicity (in vitro and in vivo)
  •      Single-Dose Toxicity / Dose-Range Finding (DRF)
  •      Repeated Dose Toxicity
  •      Safety Pharmacology
  • Particular Toxicity Testing
  •      Immunotoxicity
  •      Hepatotoxicity
  •      Phototoxicity
  •      Local Tolerance and Irritation
  •      Reproductive Toxicity
  •      Juvenile Studies
  •      Carcinogenicity
  •      Drug-Drug Interaction (DDI)
  •      Impurities Testing


You might also be interested in

Sourcing this company's services?

Send inquiry anonymously »

Or add this Company to
Sourcing cart