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

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)