Guidance for stem cell therapies in animals

The European Medicines Agency (EMA) has published the first ever guidance document for stem cell therapies in animals. The guidance addresses concerns raised by manufacturers and authorities in regard to 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.

Microbiological contamination can occur at various steps, from the initial sampling of the cells and tissues, up to the final product packaging into containers such as vials, syringes or bottles. A crucial step is the sourcing and collection of the stem cells as it is not always possible to fully implement aseptic techniques at this stage. Control for the absence of microorganisms is also key in manufacturing process controls and quality controls of cell preparations at selected stages of production. The guidance provides answers to eight main issues identified by ADVENT to support manufacturers in ensuring sterile and safe stem cell-based therapies for veterinary use.

For further details see: EMA

Posted by Dr. Tim Sandle