Dompé is committed to conducting research in the areas of biotechnology and pharmaceutics. At its industrial site in L’Aquila several facilities are dedicated to the research and development of new technologies and pharmaceutical formulations, in a constant effort to improve excellence and innovation.
Contract Development and Manufacturing Organization
The Contract Development and Manufacturing Organization (CDMO) specialises in the production of therapeutic proteins for human use. Relying on the high-level knowledge and expertise of its personnel, the organization is able to provide application responses, from gene cloning to the expression of the protein encoded by that gene, its purification and characterisation, and drug substance release in accordance with GMP requirements. Specifically, the CDMO engages in the development, optimisation and validation stages of the process; moreover, the Group’s experience in the pharmaceutical industry allows the organization to provide guidance and assistance in the regulatory procedures to third-party clients throughout all the phases of the clinical development.
The CDMO is able to manufacture and release biological and biotechnological products, such as recombinant proteins expressed by prokaryotes, in compliance with the applicable Good Manufacturing Practice requirements. In addition to the Dompé Group, the CDMO currently operates for various companies of the biotechnology sector based in Europe and North America. Several recombinant proteins manufactured by Dompé are currently in Phase I/II clinical trial for different therapeutic indications (e.g. ovarian cancer, glioma and prostatic carcinoma).
Being well equipped with various laboratories - both for Analytical Development and for Quality Control - the CDMO is able to perform extremely accurate biotechnology analyses. Recently expanded with the creation of new operational spaces in dedicated buildings, the facility has the capacity to develop, transfer and validate most of the analytical methods involved in GMP-compliant release and characterisation of biomolecules. The CDMO also houses a GLP Assay Centre for the conduct of analytical, pharmacokinetic and metabolic studies in a GLP regulated environment, including the assaying of active ingredients, impurities and metabolites in formulations and complex biological matrices (plasma, urine, tissues etc.).
Innovation & Knowledge Transfer
Innovation and Knowledge Transfer (IKT) is a unit dedicated to innovation within Dompé’s Technology R&D division. The structure’s activity is aimed at transferring to Dompé any new knowledge from advanced technology research presented by third parties (Research Centres, Universities, businesses), in order to expand the portfolio with new projects that the Group can potentially develop. Through IKT, Dompé has access to the international world of technological research excellence.
The unit also promotes networks for the shared development of high scientific value project platforms. In this respect, in the last ten years IKT has allowed the development of partnerships with public and private entities, and has become a reference point for cross-organizational research projects. At present, its activity focuses on areas ranging from the development of new therapeutic systems for controlled-release drugs to the study of innovative excipients ensuring greater protection for chemically unstable molecules; from protein stabilisation based on innovative techniques to the engineering of new biomaterials for the delayed release of proteins and small molecules.
The IKT unit is also at work in the area of ophthalmology (the goal is to optimise the intraocular release of proteins to treat the relevant diseases according to their physiopathological characteristics) and dermatology (the projects concern the controlled release of proteins for the treatment of wounds and the protection of topical formulations containing active ingredients that generate toxic species when exposed to sunlight).
Pharmaceutical Technology is the unit that engages in the development of new pharmaceutical formulations, whose active ingredient may be proprietary Dompé molecules or off-patent drugs, with the aim to sustain and expand the Group’s portfolio of medications for the OTC and Primary Care market. Its activity includes all development stages, from the creation of the experimental drug design and its realization to the identification of creative, innovative and flexible solutions leading to industrial production. The entire process is constantly monitored by a work team composed of researchers working in close contact with the Analytical Chemistry Department.
Another important part of the activities is the management of the in-house or external production of investigational drugs for clinical trials and of relationships with the CROs in charge of packaging and distributing the investigational drugs to the clinical centres.
The unit’s original organizational model ensures significant reductions of development times and costs, as well as very high quality levels: these factors are considered essential in today’s approach to advanced pharmaceutical technology. Dompé’s industrial site in L’Aquila has the capability to manufacture a broad range of solid, liquid and semi-solid pharmaceutical forms.