Preclinical studies
We conduct research and final quality control of the following:
• Originator, hybrid, combined and biosimilar drugs (including therapeutic antibodies)
• Vaccines
• Medical devices
• Medical technologies
• High-tech medicines
• Human cell-based medicinal products
For pharmacodynamics, we have a number of validated models for major pathological processes and diseases such as neurodegenerative diseases, metabolic disorders, cardiovascular diseases, trauma, cancer, and others.
List of preclinical studies:
- General toxic properties (acute, chronic toxicity, local irritant effects)
- Metabolism (toxicokinetics, in vivo pharmacokinetics, in vitro metabolism, drug interactions)
- Specific toxicity (immunogenicity, immunotoxicity, allergenic properties, mutagenicity, carcinogenicity, reproductive toxicity (generative, embryo/fetotoxicity and teratogenic effects)
- Pharmacodynamics (in vitro and in vivo studies, modelling or using transgenic animals and cell lines)
- Comparability of biosimilar drugs
- Cross reactivity of therapeutic antibodies
- Stability
- In vitro biological and immunochemical activity
- Quality control at change of production site
- Quality control of biological drugs
- Final quality control, etc.
We provide preclinical studies on a turnkey basis, encompassing the following services:
- Development and coordination with the customer of the Terms of Reference
- Development of the study plan
- Conducting the experimental part
- Conducting the study on animals
- Preparation of a complete package of documents for the registration dossier
Address: Preclinical Translational Research Centre, 43 Dolgoozernaya street, Saint Petersburg
Prof. Yulia Vakhitova, Director of Preclinical Translational Research Centre
For cooperation enquiries:
е-mail: glp@almazovcentre.ru