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Consultancy work in vaccine development

Technical regulatory dossier of veterinary vaccine

Production of the analytical dossier required for the EU deliberate release authorisation of a recombinant vaccine for poultry.
Clinical safety & efficacy study reports review and summary for a new recombinant multivalent poultry vaccine.
Analytical technical review and expert reports on new GMO vaccines destined to livestock animals.
Technical summaries and expert report on various type II analytical variations covering among others bioreactor production process conversion, inactivation method or potency test of vaccines destined to poultry, dogs, cattle and swine.

Vaccine technical development help

Expert to the Livestock Vaccines Innovation Fund (LVIF) which is an initiative developed by the Bill and Melinda Gates Foundation, Global Affairs Canada and the International Development Research Center (IDRC) based in Ottawa. LVIF represents a joint investment of CA$57 millions over seven years to support the development, production and commercialization of innovative vaccines against livestock neglected diseases in sub-Saharan Africa and South Asia.
Since 2017 and ongoing, technical review of over 30 vaccine development projects submitted for fund application by various research Institutes worldwide.
Helping IDRC funded projects by visits to vaccine development sites in Africa for technical discussion and assistance.

Recombinant vaccine antigen manufacturing transfer

Identification and management of all the technical steps required to transfer the production of an existing recombinant antigen produced in Baculovirus to a new manufacturer, including changes in culture media, passage from roller bottles to bioreactor and volume scale-up.

Technical and regulatory compliance

Assessment of technical and regulatory compliance of registered dossiers for entire product portfolios of a large veterinary product manufacturer covering EU, USA, Japan, Russia, Canada, Africa, South America and Asia.

Veterinary vaccine production

Visit of a veterinary vaccine producer in South America for an extended technical review and reporting on their facilities, products and activities in preparation to a Due Diligence.

Veterinary diagnostic kit development

Contribution to the technical re-development of an existing veterinary diagnostic kit to enhance its sensitivity and specificity.
Technical and regulatory contributions to various manufacturing transfers of diagnostic kits from Europe to US and within USA.

Vaccine analytical development training

Vaccine potency test training for the R&D department of a large veterinary manufacturer in South America covering in vitro and in vivo potency tests for live, recombinant and inactivated vaccines. Emphasis on solutions to move from in vivo to in vitro potency tests. This training resulted in a request from the Company to help devise the potency test of two of their vaccines under development.

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