Download - Klaus-Peter Behr EMAV
Klaus-Peter Behr
EMAV
} founded 2018} 20 members} 11 MS & UK} private owned / public
IABS – EMAV – Munich – Sept 2021
IABS – EMAV – Munich – Sept 2021
} 2001: exclusion from the legal framework of Dir 2001/82definition by this exclusion
} 2014:questionnaire by CMDv
} 2017: CMDv recommendations for manufacture, control and use of autogenous vaccines
} 2017: Ghent conference (IABS & University of Ghent)
} 2019: Reg 2019/6 on veterinary pharmaceuticals
IABS – EMAV – Munich – Sept 2021
IABS – EMAV – Munich – Sept 2021
IABS – EMAV – Munich – Sept 2021
IABS – EMAV – Munich – Sept 2021
IABS – EMAV – Munich – Sept 2021
IABS – EMAV – Munich – Sept 2021
} 2019: Reg 2019/6 on veterinary pharmaceuticals} 2021: EMAV-proposal for future GMP-autogenous vaccines} 2021: Munich Conference (IABS & EMAV)} 2021: PICs Work Plan 2021 including GMP autogenous} 2022: Reg 2019/ becomes applicable end of January
excluding AV-GMP at that time (article 159)} from 2022: EU-consultations on a new GMP-standard for AV-
manufacturing} 2023-2025: implementation of a new EU-GMP-standard on
manufacturing of autogenous vaccines (AV)
IABS – EMAV – Munich – Sept 2021
a non-industrial process established in Europe:
} Companies with GMP-like facilities (CZ, DE, ES, FR)} Companies manufacturing licensed vaccines mainly} Companies focusing on autogenous vaccines only
} Public / Governmental Laboratories (FR, IT, DE)
} University Laboratories (DE)
} Veterinary Practice Laboratories (BE, NL, IRL)
IABS – EMAV – Munich – Sept 2021
niche-products to fill the gaps
no licensed product available due to
} minor use / rare diseases / antibiotic resistances
} local issues / low geographical spread of a disease
} minor species / exotic species
} exotic variants
} newly emerging pathogens / interim solutions
IABS – EMAV – Munich – Sept 2021
IABS – EMAV – Munich – Sept 2021
Recital # 70:
Ø in accordance with the principles of GMP
Ø detailed GMP-guidelines should specifically be prepared
Ø preserve their quality without hindering their manufacturing and availability
Wiebke BielenbergJean de Foucault Dietmar KatingerEwald van KuppeveldBrigitte Othmar-Vielitz
Ø developed a proposal for future AV-GMPØ a result of a long processØ a compromise
most relevant parts to be presented and explained here
thanks to IABS and LMU for this conference as a platform
IABS – EMAV – Munich – Sept 2021
IABS – EMAV – Munich – Sept 2021
AV are non-industrial products :
Ø small batches
Ø wide range of antigens
Ø isolates/seeds to be used for one or few batches only
Ø wide range of batch sizes
Ø processes with different antigens in the same room after each other
Ø small revenue in case of small batches: limiting the opportunities(small batches for pets, horses, rabbits, goats, game, zoo animals)
} a positive stand-alone-document for future manufacturing and use of AV
} an attempt to implement the rules of recital # 70:„preserving quality without hindering availability“
} a compromise between private and public laboratories} a compromise between labs of different size} a compromise considering all batch sizes} adopted unanimously by the whole membership
IABS – EMAV – Munich – Sept 2021
filling: several different batches a dayin the same room
batch-size: average 30 bottles (plus 4 for QC !)1 – 250 bottles / batch
non-industrial manual filling of bottles under a class-A-. cabinet
IABS – EMAV – Munich – Sept 2021
} harmonisation based on EU-AV-GMP will increase manufacturing cost of AV
} definitions of epidemiological units and epidemiological links might increase batchsizes for AV to be used in livestock
} another balancing act: higher cost againstlarger batches(not applicable for small volume manufacturing)
IABS – EMAV – Munich – Sept 2021
a future AV-GMP shouldØ not be a collection of exemptions from
existing GMP-standards or GMP-annexesØ be a stand-alone documentØ cover all species of animals : pets as well as
livestockØ secure an identical quality level for all batch-
sizes
IABS – EMAV – Munich – Sept 2021
} AV-use only under extraordinary circumstances} AV-use only in absence of licensed vaccines} AV are needed as niche-products to fill the gaps} the prescribing veterinarian should have a central
role in this process
} the new EU-AV-GMP-standard: different from existing standards for manufacturing of licensedveterinary vaccines, different to fulfill recital #70 of 2019/6 :
„preserving quality without hindering availability“
IABS – EMAV – Munich – Sept 2021