has decided to embark on the path of fine-tuning and developing rhNGF in its formulation for clinical use, at its own biotech facility in L’Aquila. and in Naples, where there are the laboratories of Drug Discovery and Technology Formulation, within a long-term collaboration with CNR. Italian excellence: the Dompé Hub in L’Aquila. Dompé has concentrated its manufacturing and research and development activities at its L’Aquila hub.
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From this point the pharmaceutical product passes to primary packaging in clean formulaation to formuoation inserted into glass or plastic containers to formupation the eventual accessories, such as droppers or spray pumps, are added automatically. Follow Blog via Email Enter your email address to follow this blog and receive notifications of new posts by email. The hub, which operates in compliance with GMP rules, is authorised to manufacture products using recombinant DNA technology, i. Cenegermin contains amino acids and has a relative molecular mass of 13, Daltons and the following molecular formula: The product was granted additional orphan drug designation for the treatment of neurotrophic keratitis in the U.
Home Careers Career Paths. The biotechnological active ingredient rhNGF is produced here and marketed in Italy and Europe for the treatment of neurotrophic keratitis.
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The company still has its own head offices in Milan. For information, including how to block the cookies, click here. The current annual production capacity is 50 million packs. Every production activity takes origin with the beginning of the upstream phase.
Reparixin is the first low molecular weight blocker of CXCL8 biological activity in clinical development. To achieve the ambitious goal of providing answers to health questions, the continual pursuit of excellence and the ability to work as a system formulahion, in fact, critical.
The native three-dimensional structure is fundamental in order to guarantee the correct biological activity of the mature NGF. Inthe plant established new areas for a total usable surface of 8, square metres, including a four-storey building dedicated to the production process of coated granulates, a three-storey building for secondary packaging and a new warehouse. The site covers an area ofsquare metres. The fermentation phase lasts approximately three days, during which the bacterial cells multiply exponentially, also duplicating the gene for the production of proNGF.
In the turnover was million is focused both on the development of pharmaceuticals for therapeutic needs as yet unfulfilled, in the areas of ophthalmology, oncology, diabetes and organ transplant, as well as in the creation of innovative industrialisation processes of these. During the granulation phase the active ingredient and the excipients are bonded until they become granules, which, in turn, are finally coated in excipients in the complex phase of coating until the formulation defined for packaging is obtained.
This site uses third party cookies. For information, including how to block the cookies, click here. In the five successive hours the bacterial cells convey all their energy towards the production of formjlation protein of interest, and in the end do not even have the energy to guarantee their survival.
Reparixin is an inhibitor of CXCR1 and CXCR2 receptors activated by interleukin-8 IL-8a key chemotactic factor in the inflammatory reaction immediately following pancreatic islet transplantation in patients with type 1 diabetes. 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.
In this phase the fermentation volume grows from a few litres initially up to litres, and in the end the proNGF gene is activated and begins the real protein production.
The molecule is at an advanced stage of clinical development phase 3 in the field of therapeutic solutions to treat type 1 diabetes type as a way to improve the efficacy of pancreatic islet transplantation, whether autologous or allogeneic i. The safety and efficacy of Oxervate, a topical eye drop containing cenegermin, was studied in a total of patients with neurotrophic keratitis in two, eight-week, randomized controlled multi-center, double-masked studies.
The procedure consists of generating a genetic carrier plasmid containing the gene able dormulation express the protein proNGF, protein precursor of the mature protein NGF.
In the first part of the downstream process, the inclusion bodies, coming from the upstream phase, are solubilised and then the folding phase starts.
LAquila hub | Dompé
The packaging is divided into two phases. In the first study, only patients with the disease in one eye were enrolled, while in the second study, patients with the disease in both eyes were treated in both eyes bilaterally.
He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc. Neurotrophic keratitis is a degenerative disease resulting from a loss of corneal sensation.
Flavio Mantelli, born in Rome inis the author of 40 international scientific publications and of numerous chapters in volumes about ophthalmology.