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First ever guidance for stem cell therapies in animals published

Document gives advice on sterile manufacturing processes for veterinary stem cell medicines

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Veterinary Use (CVMP) recently approved the first ever guidance at European Union (EU) level for stem cell-based medicines for veterinary use, in the form of a question-and-answer document prepared by the CVMP’s Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT). 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.

Until now, no specific guidance on stem cell-based medicines for veterinary use was available from EMA. The CVMP identified the sterility of allogenic stem cell therapies as one of the priority areas where it would be useful and necessary to develop guidance, following a review of the scientific evidence, such as published literature, available guidance on stem cells for medicines for human use, experience gained by the CVMPthrough scientific advice and public consultations. More guidance concerning cell based products and other priority areas such as monoclonal antibodies is under development.

Interest and research activities into novel therapies such as stem cell or gene therapy has gathered speed over the last few years. ADVENT, a group mandated by the CVMPand composed of senior regulatory experts, brings together wide knowledge and expertise on the scientific aspects of veterinary medicines and also on their regulation. It was set up by EMA to provide general guidance on the requirements for authorisation of novel veterinary medicines and engages additional specific expertise for the development of such guidance.

Novel therapies are therapies entirely new to the veterinary sector either because they are genuinely new and have not been previously used in animals, or new only to the veterinary domain, although well known in the context of human medicines.

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