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.
- Stem cell-based products for veterinary use: Questions and answers on allogenic stem cell-based products for veterinary use: specific questions on sterility
- Scientific guidelines: Novel therapies
- Ad Hoc Expert Group on Veterinary Novel Therapies
- Veterinary regulatory: Innovation in medicines
- Committee for Medicinal Products for Veterinary Use
- Questions and Answers on allogenic stem cell-based products for veterinary use: specific questions on sterility (23/06/2017)
Latest News from
Rule of law in Poland and Hungary has worsened17/01/2020 12:05:00
The EU’s discussions with Poland and Hungary have not yet led these countries to realign with the EU’s founding values, Parliament warned on Thursday.
Parliament supports European Green Deal and pushes for even higher ambitions16/01/2020 15:25:00
MEPs support the European Green Deal, but highlight challenges, including ensuring a just and inclusive transition and the need for high interim targets.
Brexit: MEPs concerned about citizens' rights16/01/2020 13:25:00
Parliament highlights that assurances are needed on the protection of citizens’ rights to ensure its consent to the Withdrawal Agreement.
Meeting between President von der Leyen and Leo Varadkar, Taoiseach of Ireland16/01/2020 11:48:00
Remarks made at the joint press point (15 January 2020).
Trade/WTO: EU, U.S. and Japan agree on new ways to strengthen global rules on industrial subsidies15/01/2020 13:25:00
In a Joint Statement, representatives of the European Union, the United States and Japan announced their agreement to strengthen existing rules on industrial subsidies and condemned forced technology transfers practices.
EC steps up protection of European intellectual property in global markets10/01/2020 15:20:00
The EC has published the latest report on protection & enforcement of Intellectual Property Rights (IPR) in third countries. IPR infringements worldwide cost European firms €bns in lost revenue and put thousands of jobs at risk. The report identifies three groups of countries on which the EU will focus its action.
Speech by President von der Leyen at the LSE on 'Old friends, new beginnings: building another future for the EU-UK partnership'09/01/2020 12:10:00
In 1950, before our Union was formed, the UK, Italy and Germany were among the ten most populous countries in the world. Today, only one of those is in the top 20.
Eurojust becomes an Agency07/01/2020 12:05:00
Eurojust heralds a new phase in its development, as it officially becomes the European Agency for Criminal Justice Cooperation, with the application of the Eurojust Regulation as the new legal basis.
ESMA extends recognition decisions for 3 UK CCPs in the event of a no-deal Brexit24/12/2019 10:25:00
The European Securities and Markets Authority (ESMA) has announced that it has extended the recognition decisions for the 3 central counterparties (CCPs) established in the UK to reflect the extension of the expiry date of the Implementing Decision (EU) 2018/2031 of the EC on the equivalence of the UK CCP legal framework.