On 27-28 October 2008, the European Directorate for the Quality of Medicines & HealthCare (EDQM) held a meeting in Strasbourg on the use of the PCR (Polymerase Chain Reaction) technique in the testing of veterinary vaccines.
Representatives from the human and veterinary vaccine industry and a number of Official Medicines Control Laboratories (OMCLs) participated in the meeting. The European Medicines Agency (EMEA) was also represented, and the Danish Medicines Agency was represented by Annette Malene Barfoed and Peer Lyng Frandsen, Academic Employees.
Animal testing and the use of the PCR technique in the testing of veterinary vaccines
Veterinary vaccines are tested for extraneous agents, which must not be present in the vaccine as they consist of other viruses and bacteria than those upon which the vaccine is based. The point is therefore that the vaccines must not be contaminated.
The traditional method for the testing of veterinary vaccines is animal testing, whereas the PCR technique does not involve animal testing. There is much focus on reducing the use of and preferable avoiding the use of animal testing – in general and in connection with the testing of veterinary vaccines.
The PCR technique is continuously developing within the testing of veterinary vaccines, and in line with improvements in the technique, it will be able to reduce and, in time, hopefully replace the use of animal testing. Another significant aspect is that the PCR technique makes it simpler, cheaper and faster to test vaccines than is the case with animal testing.
The representatives from the Swiss OMCL have made a huge effort to develop PCR analyses for the detection of extraneous agents in avian virus vaccines. There is now a need for thoroughly testing the analyses developed, and there is also a need for developing tests for other vaccines. In both cases, a combined effort from the OMCL and industry is required.
Establishment of working groups
At the meeting in Strasbourg, it was decided to establish a strategic and a technical working group. The strategic working group must draft an action plan (concept paper) for the further work within PCR tests to make it possible to establish common standards for the use of PCR. The technical working group must contribute with knowledge and laboratory work for the development and validation of PCR tests. The Danish Medicines Agency will participate in both working groups.
The laboratory of the Danish Medicines Agency already hosts a number of activities within PCR for the detection of virus. These activities were presented at the meeting and were met with great interest from, among others, the representatives of the veterinary pharmaceutical industry.
For further information, please contact Annette Malene Barfoed, Academic Employee, tel. +45 4488 9119 or Peer Lyng Frandsen, Academic Employee, tel. +45 4488 9276.
Danish Medicines Agency, 16 February 2009
