Contact
Veterinarians can contact Dopharma, in order to obtain more information on the possibilities this cooperation and Dophavacc can provide to you.
Before you do so, please check the FAQ’s (frequently asked questions) below first.
If your question is not mentioned, our team would be happy to help you!
Frequently Asked Questions
Why should I use Dophavacc?
Autogenous vaccines are a valuable addition to the veterinarians’ toolbox. Autogenous vaccines can be altered with evolving pathogens. This flexibility of an autogenous vaccine is of added value specifically when antigenic properties of pathogens change over time. Autogenous vaccines are a welcome addition for prevention of infectious diseases, promoting animal welfare and food safety and reduction of infection pressure, antibiotic use and antimicrobial resistance.
What is the legal basis for the use of autogenous vaccines?
The legal basis is provided by Article 2(3) of Regulation (EU) 2019/6:
“[…] inactivated immunological veterinary medicinal products, which are manufactured based on pathogenic organisms and antigens isolated from an animal or animals belonging to an epidemiological unit, and are used for the treatment of that animal or those animals within the same epidemiological unit or for the treatment of one or more animals in a herd with a confirmed epidemiological connection.”
What is meant by an epidemiological unit?
According to Article 4 No. 44 of Regulation (EU) 2019/6 and Article 4 Number 39 of Regulation (EU) 2016/429, an epidemiological unit is a group of animals, in which the likelihood of exposure to a contagious agent is equally high.
The movement of animals between rearing sites/farms should be considered when establishing the epidemiological link. As a consequence, animals raised on rearing sites/farms geographically distinct, that have an epidemiological link, are belonging to the same locality. It is mainly applicable for poultry or pigs when considering parental lines raised in production chain systems. For aquatic animals, an epidemiological link also exists between different farms/sites within one geographic area; where an identical pathogen is circulating and spread e.g. by wild aquatic species.
What is Ripac-Labor’s quality standard?
According to the Regulation (EU) 2019/6 (Consideration 70, Art. 2(3) and Art. 94), autogenous immunological veterinary medicines should be manufactured in accordance with the principles of good manufacturing practice (GMP). Anyway, there are no european GMP-guidelines for the production of autogenous vaccines established yet. Until the issuance of the corresponding GMP guidelines for autogenous vaccines pursuant to Regulation (EU) 2019/6, Ripac-Labor produces its vaccines following the existing german legislation and orientates its manufactoring and quality assurance on the requirements specified in the „question & answer paper“ published by the Central Office of the Federal States for Health Protection in Medicines and Medical Devices (ZLG Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten).
Ripac-Labor’s GMP-compliant production is verificated by regularly inspections by the State Office for Occupational Safety, Consumer Protection, and Health (LAVG). Furthermore Ripac-Labor implemented a quality management system to constantly check and prove the quality of internal processes and systems through self-inspections and comprehensive quality control measures.
Which and how many animals should I sample?
It’s important to sample only animals that show symptoms of acute clinical disease. These animals should not have been treated with antimicrobials for at least a week before sampling. A certain amount of samples is needed, depending on the disease. Please contact your local technical support team for advice.
How can I transfer strains from a local laboratory to Ripac?
Ask your local laboratory to send a swab with transport medium of the pure culture to Ripac-Labor:
RIPAC-LABOR GmbH
Am Mühlenberg 11
D-14476 Potsdam-Golm
Germany
Phone: +49 (0)331 5818400
You can also send samples for diagnostic services to Ripac-Labor directly.
How long does it take to produce an autogenous vaccine?
Depending on the chosen antigen, the production of an autogenous vaccine takes 6 to 8 weeks (does not apply to viral vaccines).
What is the shelf life of an autogenous vaccine and how can it best be stored?
Shelf life of autogenous vaccines is six months. When a bottle is opened the first time, it should be used within a working day (8 hours). Bottles should be stored between 2 to 8 °C and protected against light and frost.
Where can I report complaints or adverse events concerning Dophavacc autogenous vaccines?
You can contact your local Dopharma representative or Ripac-Labor. There is no safety testing possible for autogenous vaccines. Therefore, it is recommended to test the tolerability of the vaccine in 2-5 animals before treating the flock. Follow these animals clinically for the next 7 days to test the tolerability.
What is the EMAV?
RIPAC-LABOR is a member of the EMAV, the association of European Manufacturers of Autogenous Vaccines and Sera. The EMAV represents the leading European producers of autogenous vaccines and sera for farm, companion and exotic animals. The EMAV published a manual with guidelines for production and application of autogenous vaccines. This unique publication was prepared by well recognized scientists from veterinary universities in Europe, experienced veterinary experts and specialists from the circle of EMAV member companies.
