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Non-Clinical Immunization Studies

The process of drug development involves non-clinical and clinical studies. Non-clinical studies are conducted using different protocols including animal studies. 

During the early pre-clinical development process, also known as Go/No-Go decision, a drug candidate needs to pass through several steps, including the determination of pharmacokinetic characteristics such as drug availability, absorption, distribution, metabolism, and elimination (ADME). These preliminary studies generally do not need to comply with GLP regulations. The aim of such studies is to investigate the safety of a drug in terms of its tolerability in various systems and by doing so provide the basis for further decision making. 

Your Study with BioGenes

 

BioGenes offers non-clinical immunization studies in animals including mice, rats or rabbits for several applications (non-GLP). 

 

Our service includes:

  • Testing of various adjuvants
  • Testing of new vaccines
  • Challenge of vaccinated animals with the corresponding pathogen (for mice up to biosafety level 2) 
  • Comparison of different routes of drug delivery
  • Provision of blood, faecal and urine samples at various times after drug administration including final organ extraction

Depending on your project’s aim, the following parameters are recommended to be discussed with our experts:

  • Information about the type, availability and biological characteristics of the drug
  • Selection of application routes
  • Suitable animal species and strain
  • Number of animals per immunization group
  • Selection of the suitable adjuvant and immunization scheme

We would be glad to customize any non-clinical immunization study according to your needs. Talk to our experts today.

Why BioGenes?

 

  • Long-term experience in immunization of various animals and development of antibodies
  • Team of scientific specialists and project management experts
  • Extensive inhouse animal and lab facilities in compliance with the German Genetic Engineering Act and the German Biological Substances Ordinance (up to safety level 2)
  • Our state-of-the-art animal facilities have already been successfully audited by several clients, from medium-sized biotech to big pharma companies 

Contact 

If you need more information, a specific offer 
or want to talk to an expert

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