EXPERIENCE AURIGON’S LONG STANDING EXPERTISE IN THE DEVELOPMENT OF BIOLOGICS
Nowadays, biological products represent the cutting-edge of biomedical research and offer the most effective means of treating a variety of medical illnesses and conditions for which no other treatments are currently available.
Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, amino acids, proteins or nucleic acids, or possibly complex combinations of these substances. They are isolated from a variety of natural sources – human, animal, or microorganism – or may be produced by biotechnological methods or other cutting-edge technologies.
During more than 15 years, our scientists have developed a deep insight into the variety of the products and defined their specific needs for the pharmacological and safety evaluation of these products. Together with our clients, we have developed customised testing strategies and study designs to overcome the challenges of each specific product.
Our facilities and services cover all requirements for the non-clinical testing of NBEs:
- Studies according to the latest FDA, EMA and ICH guidelines
- GLP-compliant animal houses, quality assurance and audit reports in all GLP-compliant studies
- Multiple modes of administration (incl. long-term infusion, s.c. osmotic mini-pump, transdermal)
- Animal handling in accordance with the 2010/63/EU guideline and under the control of the Institutional Animal Care and Use Committee
Explore our special services for the pharmaceutical development of biologics:
- Customised development of biological activity assays
- GMP-compliant batch release testing
- Wide panel of immunotoxicity testing