It is with the deepest regret that we have to inform you that Hypermune is currently not available. This is because the Veterinary Medicines Directorate (VMD) put a sudden stop on its release of the product in August which effectively means that all production since June is locked up in our quarantine freezers.
The situation arose from a GMP inspection in August of the Quality Control test laboratory, appointed and approved in March 2021 by the VMD, following the closure of the Animal Health Trust, which tests weekly samples of plasma for extraneous agents, two pairs of named globally endemic viruses. The issue centres round the fact that Veterinary Immunogenics Ltd (VIL) sends samples from its storage freezers in moulded polystyrene packaging at ambient temperature by express overnight carrier for mid morning timed delivery next day. The regulatory guideline stipulates that they should be sent at the same defined storage temperature for the product, which is -20°C to -30°C to maintain quality.
It was explained to the VMD that this method has been used for over 20 years to ensure the product arrives thawed and able to be tested on arrival. The VMD then demanded risk assessments be conducted to see if this process undermined the validity of the test. VIL agreed to instigate this with not only the extraneous agent testing lab but also another two – one for sterility testing and one for quality testing. However, this all depended on time demands on the laboratories devising and setting up studies while working in difficult circumstances due to covid. Therefore, VIL asked the VMD to lift the stop on product release on the strength of the safety record of the products Hypermune and Hypermune-RE over 29 years when in excess of 86,000 litres has been supplied without, as far as we are aware, any related problems linked to contamination. The VMD refused.
There is on going work on this issue along with other tasks subsequently additionally requested by the VMD. It is going to take time for VIL and the laboratories to complete the studies and document reports for the VMD. We have emphasised our concerns regarding the potential neonatal foal welfare issues from septic disease, along with the concomitant increase in antibiotic usage.
Meanwhile all the personnel at VIL are puzzled why the matter of sample transport has never been raised during the regular inspections of the AHT over 20 years or on site inspections at VIL over 20 years, the most recent being 26th May 2021 which resulted in a Certificate of GMP compliance being issued in July 2021.
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HYPERMUNE RE has completed its first five years as an authorised veterinary medicinal product and in 2012 was granted a renewal "for life" by the Veterinary medicines Directorate and the Irish Medicines Board. The UK government Home Office has granted a new 5 year Project Licence for the company to continue producing plasma from horses until March 2022.
On 26th of May 2021 the UK regulatory authority, the Veterinary Medicines Directorate conducted its routine searching site inspection and processes at Veterinary Immunogenics Ltd. Once again the company proved it takes Good Manufacturing Practice very seriously by meeting all the high standards required and has been granted a new Good Manufacturing Practice certificate.
Following the sporadic incidents of Equine Infectious Anaemia in the United Kingdom in 2010 it is still reported by the authorities that the risk of spread or further incidents is considered to be very low. Nevertheless, Veterinary Immunogenics Ltd provides continuing assurance that HYPERMUNE and HYPERMUNE RE are produced in the United Kingdom in compliance with strict protocols to ensure consistent product quality and safety. These include the testing of every donor horse to ensure its freedom from a specified range of disease-causing agents including Equine Infectious Anaemia as well as constantly monitoring the UK horse health status for exotic and emerging diseases. Final product testing on every plasma harvest further endorses this standard.
HYPERMUNE and HYPERMUNE-RE have national UK Marketing Authorisations.
HYPERMUNE-RE has also been granted a full Marketing Authorisation by the Irish Medicines Board. This product is available for direct supply to Veterinary Surgeons in Ireland as well as the UK and carries harmonised labels and product literature.
The Veterinary Medicines Directorate has an updated list of licensed veterinary products online. For more online resources see the entries for Veterinary Immunogenics, HYPERMUNE and HYPERMUNE-RE in the UK National Office of Animal Health (NOAH) Compendium of Animal Medicines.
GAMMA CHECK KITS. Unfortunately we are unable to make these kits due to the world wide unavailability of one key component. Accurate testing for IgG is our recommendation using a laboratory based validated quantitative test.
We are very aware of the fluctuating exchange rates of currencies at the present time, particularly after the "Brexit" referendum result in the summer of 2016. We are therefore, striving to operate with maximum efficiency to restrain costs and thus strictly limit price increases only where absolutely necessary.
We attended Brexit meetings in Dublin and at the VMD headquarters in London but no valuable information has yet been learned regarding any changes that may impact the availability of HYPERMUNE and HYPERMUNE-RE after Brexit.
For more information on plasma use, in addition to Failure of Passive Transfer, see the HYPERMUNE-REview volume 1 (January 2009) and HYPERMUNE-REview volume 2 (January 2010). Please also see the Newsletters archives and FAQs avialable in the reference section of this site
For further information please contact us.
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