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.
Posted by Dr. Tim Sandle