Stem cell-based products for veterinary use: specific questions on sterility to be addressed by the Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT) - Scientific guideline

Current version - Revision 1

Questions and Answers on allogeneic stem cell-based products for veterinary use: specific questions on sterility - Revision 1

Adopted Reference Number: EMA/CVMP/ADVENT/751229/2016-Rev.1

The guidance, in the form of questions and answers, addresses concerns raised by manufacturers and authorities regarding the sterility (absence of bacteria, fungi and mycoplasma) of allogenic stem cell therapies in the veterinary sector. Allogenic stem cell-based veterinary medicines originate from tissues (such as bone marrow or fat) from a donor from the same species of animal, not from the recipient of the cells. These products are manufactured in large batches which need to be sterile as they are administered by injection directly into the body. The guidance was developed following a review of scientific information in relation to stem cell products intended for veterinary use.

Keywords: Stem cell, veterinary, microbiological control, manufacture, good manufacturing practice (GMP)

Document history

Questions and Answers on allogenic stem cell-based products for veterinary use: specific questions on sterility

Adopted Reference Number: EMA/CVMP/ADVENT/751229/2016

Stem cell-based products for veterinary use: specific questions on sterility to be addressed by ADVENT - draft

Draft: consultation closed Consultation dates: 04/03/2016 to 15/05/2016 Reference Number: EMA/CVMP/ADVENT/226871/2015 Summary:

Cell-based medicinal products (CBMP) are heterogeneous with regard to the origin and type of cells and to the complexity of the product. Cells may be self-renewing stem cells, more committed progenitor cells or terminally differentiated cells exerting a specific defined physiological function.