advanced therapy

Advanced Therapy Medicinal Products

Therapies and medicines, including regenerative medicine and more personalized treatments, are undergoing a rapid expansion. Advanced therapy medicinal products (ATMPs) are medicines for human use based on genes, cells and tissues. ATMPs are at the cutting edge of innovation and provide new opportunities to tackle a range of diseases presently with limited or no therapeutic options.

ATMPs can be classified into four main groups:

  • Gene therapy medicines: these consist of genes that result in a therapeutic, prophylactic or diagnostic effect after inserting recombinant genes into humans to treat a variety of diseases (e.g. genetic disorders, cancer or long-term illnesses).
  • Somatic cell therapy medicines: these are based on the administration of manipulated cells or tissues to humans, which serve to cure, diagnose or prevent diseases.
  • Tissue engineered products (TEP): contain or consist of engineered cells or tissues, which are administered to humans to regenerate, repair or replace human tissue.
  • Combined ATMPs: contain one or more medical devices as an integral part of the medicine. Check this link to learn more about medical devices.

Our Services

Nonclinical safety assessment studies including:

 

  • Biodistribution
  • Tumorigenicity
  • Immunogenicity
  • Acute and repeated exposure, available with a selection of dose routes in the relevant species.
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OUR EXPERTISE
Vivotecnia has a wealth of knowledge about preclinical studies with advanced therapy medicinal products. ATMPs require sequential testing over long periods and our highly experienced team will help you design your studies according to regulatory requirements.

When bench-to-bedside translational research is required, Vivotecnia is ready and willing to assist you.

REGULATORY FRAMEWORK
The main standard European references are Directive 2001/83/EC on the Community code relating to medicinal products for human use and Regulation (EC) No. 1394/2007 on Advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004.

For further information about ATMPs, check out this link: EMA

CONTACT

For more information or a formal quotation, please send us a message and we will contact you as soon as possible.



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