Toxicology testing of drug candidates

Our aim is to protect human health from potential adverse effects of pharmaceuticals and to help assess and manage potential risks – by using our expert knowledge in toxicology.

We offer our clients a broad range of toxicological tests enabling assessment of potential risks to human health. Substances we investigate include pharmaceuticals such as traditional chemically synthesized drug products, biopharmaceuticals, phytopharmaceuticals, vaccines, and ATMPs. Our expertise ranges from the development and implementation of testing strategies to accompanying and providing consultancy to companies in registering their products. Special expertise in inhalation toxicology is available.

 

 

Our key topics

 

Pharmaceuticals, biopharmaceuticals, and phytopharmaceuticals

 

Mechanistic and in-vitro toxicology

 

In-vivo Inhalation Toxicology

Our services and expertise

We advise and support our clients in selecting the most appropriate study design, work out concepts for registration and authorization of products, and perform toxicological studies with different routes of administration depending on the client’s particular requirements.

Custom-tailored tests, whose compliance with regulatory requirements is guaranteed:

  • In-vitro studies (genotoxicity, molecular toxicity, screening tests)
  • Ex-vivo studies (e. g. precision-cut lung slices, PCLS in short)
  • In-vivo studies (relevant species, single-dose and repeated-dose toxicity, reproductive toxicity)
  • Saftey pharmacology (core battery)
  • Special focus on inhalation toxicology and immunotoxicology
  • Testing strategies to support customers in scientific advice and registration processes
  • Experience with biopharmaceuticals, oligonucleotide-based drugs, and advanced therapy medicinal products (ATMPs) as well
  • Study performance in compliance with OECD GLP guidelines, whenever required

Your benefits

© Fraunhofer ITEM
  • Comprehensive consulting and support throughout the registration and authorization process
  • For the authorization of biopharmaceuticals, we develop tailored concepts with specific testing strategies and discuss these with the competent authorities
  • Access to a broad range of methods, special methods, and validated test systems and models
  • By serving as advisors in various committees, we are always up to date on changes in the relevant guidelines
  • As a non-university research institution, we can be a partner in applying for public funding