klaus-peter behr emav

Klaus-Peter Behr

EMAV

} founded 2018} 20 members} 11 MS & UK} private owned / public

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


} 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)


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)


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



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



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


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


} 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)


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


} 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“


klaus-peter behr emav

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