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L'Aquila hub

Italian excellence: the Dompé Hub in L’Aquila

Dompé has concentrated its manufacturing and research and development activities at its L’Aquila hub.

The Dompé plant in L’Aquila, located on the Campo di Pile industrial site, was opened in 1993. The site covers an area of 157,668 square metres. The buildings that house the research laboratories, the production, the warehouse, the utilities, the general services and the administrative offices cover a total area of over 36,200 square metres.

Innovation and technologies in Research & Development

Several different facilities, dedicated to the research and development of new synthetic and biotechnological drugs, are in operation at the Dompé hub in L’Aquila. The hub employs 70 researchers and now, thanks to the special technical and scientific skills accumulated over the years, the facility is able to cover the entire Drug Discovery process, from the initial research stages up to final clinical development. The core of this research is the “Drug Design and Discovery Platform” and “Early Clinical Development Platform”. It is proposed that these integrated platforms will concentrate, above all, on developing new drugs for pathologies that still do not have effective treatments.

In the Research & Development laboratories, Dompé carries out rational planning studies of new drugs, thanks to the coordination of the Units of Bioinformatics and Computational Chemistry, Medicinal Chemistry, Cellular Biology, Preclinical Pharmacology and Technical Pharmaceutics that operate in order to identify new molecular candidates for clinical development.

The work of the Technology R&D laboratories also aims to study new materials, new vehicles, new methods of drug administration, their characterisation and the analysis of the chemical-physical interactions between drug and delivery system participating in collaborations of scientific relevance, established within a national and international network that today involves over 200 organisations including Harvard University, Houston Methodist Hospital, Stanford University, Columbia University, Karolinska Institute (Sweden), and the National Institute of Health (NIH).

Read more about Dompé’s commitment to Research & Development.

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Contract Development and Manufacturing Organization (CDMO)

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Biotech Formulation (BF)

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Primary Care Formulation (PCF)

Pharmaceutical Production

The L’Aquila facility is the production site for the main drugs marketed by Dompé in Italy and all around the world.
This non-stop development and implementation facility hosts two production lines dedicated to packets, three lines dedicated to sticks, one line for syrups and one line for dosed vials.

The Dompé plant produces granular products, orosoluble granules, syrups, mouthwashes, drops and sprays.

The production lines are continuously being updated and expanded, as a consequence of the increased demand for products for the Italian and international market and the continuous need for harmonisation with current international standards.

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The production of granules

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Liquid production

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Packaging

 

Biotechnological Production

The centre includes a state-of-the-art biotechnology facility designed for the research and development of therapeutic solutions in the field of rare diseases and orphan therapies, with authorisation from Italy’s regulatory authorities in accordance with European guidelines.

At its biotech plant, the company has specialised in the development of new processes and in the production of biotech products on an industrial scale. The hub, which operates in compliance with GMP rules, is authorised to manufacture products using recombinant DNA technology, i.e. by transferring human genetic material to a bacterium, a process by which a protein can be produced that is fully complementary to human proteins.

The biotechnological active ingredient rhNGF is produced here and marketed in Italy and Europe for the treatment of neurotrophic keratitis.

Biotechnological production comprises one upstream phase (the production of the active principle from biological material) and one downstream phase (purification).

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Find out more about rhNGF production

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The upstream phase

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The downstream phase

 

A constantly developing centre

The Dompé Group has implemented an intense growth-oriented policy at the L’Aquila hub. The investments over time—over €200 million—have mainly been concentrated on the following phases:

  • “Turnkey” plant established by Foster Wheeler in 1993
  • First biotechnology plant pilot production (at the time the most innovative in Europe) in 1996
  • New biotechnological production plants on an industrial scale built between 2012 and 2014
  • Expansion for the construction of new production lines (2014-2018). The Contract of Development with Invitalia enters into this scope, to a total value of €41 million.

Industry 4.0: the smart factory

In 2013, the L’Aquila hub launched an implementation plan based on the “Smart Factory Industry 4.0” concept, with the goal of giving momentum to the strategic growth plan by orienting everything towards productivity, quality and the optimisation of resources.

The activities being implemented included continuous control, through a monitoring network consisting of 1,100 elements (SCADA) that monitor the areas and production facilities. Everything is monitored, from air quality to water quality to the pulverisation process. This makes it possible to guarantee the high quality standards required by the pharmaceutical sector, which is heavily regulated.

Another activity being implemented is data protection, known as “Data Integrity”, which is based on the idea of processing data, whether gathered from pharmaceutical processes or factories, through the use of special protection systems that prevent damage or involuntary of fraudulent modifications. The application of Smart Factory concepts in the pharma context, in fact, is accompanied by certain peculiarities linked to qualitative and regulatory aspects. The data on production processes serve as formal documents testifying to the quality of the process/product, and thus need to be managed in accordance with precise guidelines to guarantee their authenticity, integrity, security and inalterability.

“Data Integrity” - Dompé uses an automation strategy applied to every L’Aquila site in the form of a single hardware and software architecture that covers every system. An audit trail system serves to register, in an inalterable manner, every operation carried out during processing.

Projects using Artificial Intelligence techniques (Neural Networks, Fuzzy Logic) are also under way at the facility for analysing and optimizing certain production processes. During the ISCRE 2018 International Convention (International Society of Chemical Reaction Engineering), Dompé and the Faculty of Industrial Engineering of the University of L’Aquila presented the study “Application of neural networks for the recursive identification of the bacterial growth model in the Escerichia Coli fermentation process” in which the resulting systems of Artificial Intelligence applied to biotechnological production were illustrated. In particular the study dealt with the mathematical modelling of the biotech fermentation process for the production of NGF having used AI techniques.

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