Production of Diagnostic, Reagents and Vaccines
The Laboratory is responsible for producing vaccines, diagnostic tools, and therapeutic agents aimed at preventing, diagnosing, and treating contagious and zoonotic animal diseases, both in livestock and companion animals. Over the years, production has expanded and diversified to meet the evolving needs of its clients.
The Laboratory for the Production of Diagnostics, Reagents and Vaccines of the Institute is organised into two departments:
- Production of Bacterial Vaccines and Diagnostic Tools
- Production of Viral Vaccines and Diagnostic Tools
The mission of the Laboratory has always been the production of vaccine, diagnostic, and therapeutic products aimed at the prevention, diagnosis, and treatment of contagious and zoonotic animal diseases, both in livestock and companion animals. Over time, production activities have expanded and diversified in order to effectively respond to the evolution of the sector and to client needs.
On behalf of the Ministry of Health, the Laboratory produces and distributes to the entire network of Italian Istituti Zooprofilattici Sperimentali and to the Veterinary Services of the Local Health Authorities the following: the Rosa Bengala Unified Antigen and the 2nd National Standard Positive Serum for Brucella abortus for the diagnosis of brucellosis; the C-ELISA Kit for the diagnosis of bluetongue; and the Bovine PPD Tuberculin for the diagnosis of tuberculosis.
Upon request from veterinary practitioners, the Laboratory produces stall-specific vaccines and autogenous vaccines for the most common bacterial diseases affecting livestock and companion animals.
The current catalogue includes approximately 90 different commercially available products.
The Laboratory also provides services to other IZS facilities, including:
- The production of about 400 types of ready-to-use culture media, both solid and liquid, for the diagnosis and detection of microorganisms in diagnostic samples and food intended for human and animal consumption.
- The preparation of sera, antigens, and reference materials used in ring trials organised by National Reference Centres (Brucellosis, CESME), WOAH Reference Laboratories (Brucellosis, Contagious Bovine Pleuropneumonia, Bluetongue, and West Nile Fever), and National Reference Laboratories (Listeria, Campylobacter, and Dioxins).
- The washing and sterilisation of all IZS glassware.
- The sterilisation of contaminated waste generated by diagnostic and biological production activities.
In order to meet updated regulatory and quality requirements, the Laboratory has recently been equipped with a Pharmaceutical Production Facility that will significantly increase the production capacity of antigens, reagents, diagnostic kits, and vaccines. This facility also meets legal requirements and operates according to GMP standards, ensuring both operator safety and production process quality for the protection of public health.
Alongside production and service provision, the Laboratory is engaged in experimental and applied research for the development and validation of new immunising products, monoclonal antibodies, recombinant proteins, and innovative diagnostic products for the prevention and diagnosis of infectious animal diseases, with particular attention to exotic diseases at risk of introduction into Italy and Europe. The protection of our livestock heritage and biodiversity through the use of vaccines and the early diagnosis of emerging diseases fully aligns with the «One Health» approach, which integrates human, animal, and environmental health.
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Maria Teresa Mercante
Head
She holds a Master’s degree in Biological Sciences from the University of L’Aquila (1988). Since 1993, she has been working at the Istituto Zooprofilattico Sperimentale dell’Abruzzo e del Molise, where she currently serves as Head of the Viral Vaccine and Diagnostic Products Production Department and, ad interim, as Head of the Laboratory for the Production of Diagnostics, Reagents and Vaccines.
She holds a Master’s degree in Biological Sciences from the University of L’Aquila (1988). Since 1993, she has been working at the Istituto Zooprofilattico Sperimentale dell’Abruzzo e del Molise, where she currently serves as Head of the Viral Vaccine and Diagnostic Products Production Department and, ad interim, as Head of the Laboratory for the Production of Diagnostics, Reagents and Vaccines.
Between 1993 and 1999, at the Serum and Vaccine Management Laboratory, she gained experience in the preparation of dossiers for vaccine registration (marketing authorisation granted by the Ministry of Health).
From 1999 to 2003, she worked in the Quality Assurance and Control Department, acquiring experience in laboratory accreditation according to ISO 17025.
From 2009 to 2018, she worked in the Sample Reception and Control Department, which she headed from 2019 to 2021. During this period, she gained experience as LIMS administrator. As administrator and contact person for the Laboratory Information System (SILAB), she was part of the working group for the SILAB for Africa project and, at national level, participated in the working groups for the SILAB_Sicilia and SILAB_PB projects.
The activities of the Department she currently leads focus on the development of experimental vaccines against viral diseases, with particular attention to exotic diseases, and on the production of viral and protozoan diagnostic tools for research and for the serological diagnosis of infectious diseases using monoclonal antibodies and recombinant proteins.
A large part of her work is dedicated to participation in national and international research projects aimed at the development and validation of new immunising products, monoclonal antibodies, recombinant proteins, and diagnostic tools for the diagnosis of infectious animal diseases.
She has participated in numerous conferences and training courses, both as a participant and as a lecturer. Author of 32 publications in national and international journals.
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Production of Bacterial Vaccines and Diagnostic Tools
Go to the UnitThe Unit specialises in the production of bacterial vaccines, diagnostic tools, reagents, and culture media to support the diagnosis and control of infectious animal diseases.
Production of Viral Vaccines and Diagnostic Tools
Go to the UnitThe Unit's objectives include the development of safe and effective vaccines to counter emerging exotic diseases, as well as the study, validation, and production of diagnostic tools to monitor the spread of endemic and exotic diseases present in, or at risk of being introduced into, our country. These goals align with the EU Animal Health Strategy and the One Health principle, as outlined in Regulation (EU) 2016/429.
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