DEPARTMENT OF PHARMACY: A HUB OF EXCELLENCE IN RESEARCH AND INDUSTRIAL SERVICES
Ranked as a "Department of Excellence" for the 2018-2022 and 2023-2027 mandates, the Department of Pharmacy provides high-tier strategic services, leveraging world-class expertise and resources to meet the diverse needs of the industrial sector.
We specialize in preclinical pharmaceutical research, dedicated to the discovery of novel drug candidates and the optimization of existing therapeutic solutions.
Expanding beyond the pharmaceutical core, the Department offers comprehensive R&D support for the Food and Cosmetic industries, including:
- Product Innovation: Development of advanced and sustainable formulations.
- Analytical Excellence: High-precision laboratory testing and characterization.
- Safety & Quality Assurance: Rigorous protocols to ensure regulatory compliance.
- Efficacy Assessment: Scientific validation of product performance and claims.
Task Force di Ateneo "Nutraceutici ed Alimenti Funzionali"
La task force di Ateneo (TFdA) per la Nutraceutica e gli Alimenti Funzionali, ha tra i suoi obiettivi principali quello di fornire alle aziende che operano nel campo dei prodotti alimentari a valenza salutistica (quali integratori alimentari, alimenti destinati a fini medici speciali, alimenti arricchiti e, più in generale, alimenti funzionali) servizi volti a sviluppare nuovi prodotti, migliorarne la qualità garantendone, su basi scientifiche robuste, la sicurezza e l'efficacia, in accordo con la normativa di riferimento. La multidisciplinarietà dei docenti e ricercatori, afferenti ai Dipartimenti dell'Ateneo Federico II di Napoli, garantisce la totale copertura delle competenze necessarie per la ricerca e lo sviluppo di prodotti innovativi e di elevata qualità, le cui proprietà siano certificate da studi condotti con elevato rigore metodologico, seguendo la regolamentazione in vigore e le linee guida emesse dalle principali istituzioni che operano nel campo dei prodotti a valenza nutraceutica e della certificazione della qualità.
Allegati:
Center of Pharmacoeconomics and Drug Utilization Research
The Center of Pharmacoeconomics and Drug Utilization Research (CIRFF) of the University of Naples Federico II has been, since 2004, one of the few university-based centres in Italy working in the fields of Drug utilisation, Pharmacoeconomics, and Outcome research. The Centre's mission is to promote, disseminate, and conduct basic and applied research on the evolving dynamics of the healthcare sector. It also aims to spread scientific knowledge on the organisation and delivery of healthcare. The long-standing experience of its research group and the reliability of its studies, reflected in many international publications, make CIRFF a trusted partner for institutions, companies, and stakeholders. These actors face the ongoing challenges of an economic and social environment that is constantly changing. CIRFF is based within the Department of Pharmacy of the University of Naples Federico II. Since 2018, it has been a Partner of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) of the European Medicines Agency (EMA).
Companies interested in the services offered are invited to contact Professor Valentina Orlando and Professor Enrica Menditto at cirfefu@unina.it
FoodLab Laboratory (N45)
The FoodLab Laboratory (N45) operates within the Department of Pharmacy at the University of Naples Federico II and employs advanced methodologies and instrumentation, including UHPLC-DAD, spectrophotometers, and high-resolution mass spectrometry (UHPLC Q-Orbitrap HRMS), in accordance with a Quality Management System certified by IMQ STD ISO 9001:2015.
The research group has consolidated expertise in the chemical characterization of bioactive compounds, such as polyphenols, anthocyanins, hydro- and liposoluble vitamins, and amino acids, derived from natural and processed food matrices, health foods, and nutraceuticals. This expertise extends to the valorization of food industry waste and by-products, regarded as eco-sustainable sources of bioactive compounds that can be proposed as ingredients for formulating nutraceuticals or functional foods. The group also conducts evaluations of related biological activities, including antioxidant and anti-inflammatory effects. A further key aspect involves assessing the bioaccessibility of these compounds through in vitro simulation of gastrointestinal digestion using the Infogest protocol.
The laboratory is also involved in optimizing conventional and innovative dosing techniques and methods for quality control and qualitative-quantitative analysis of contaminants (mycotoxins, acrylamide, veterinary drug residues, and pesticides) in food matrices, animal feed, and biological fluids. Particular attention is given to the qualitative-quantitative determination of Δ9-tetrahydrocannabinol (THC), cannabidiol (CBD), and minor metabolites (CBG, CBGA, CBDA, CBC, CBN, THCA) in inflorescences and oleoresins obtained from Cannabis sativa L. Analyses are performed using HRMS Q Exactive Orbitrap mass spectrometry, with certification compliant to regulations on cannabis use in the therapeutic sector. In parallel, it is possible to quantify Cannabis-derived metabolites in nutraceutical products (pasta, baked goods, oil, etc.). The laboratory also conducts advanced proteomics and metabolomics studies applied to various biological, food, and environmental matrices, employing cutting-edge techniques for molecular characterization and functional analysis.
Companies interested in the services offered are invited to contact Dr. Luana Izzo at the following email address: luana.izzo@unina.itt
RD Cosmetics LAB
The RD Cosmetics laboratory was founded in 2005. Today, we are a working group that boasts not only twenty years of experience, but also a large number of passionate young researchers full of energy and enthusiasm, coordinated by Prof. Sonia Laneri and Dr. Ritamaria Di Lorenzo. The laboratory also adopts an ISO 9001 Standard Quality Management System certified by IMQ.
The cosmetics sector is constantly searching for new products and increasingly high-performance raw materials, which is why in our laboratory we support corporate research and development on new biologically active molecules derived from plant matrices or agri-food waste with antioxidant activity. We study the flow and differentiated accumulation of active substances on the skin and prepare innovative formulations for dermal and transdermal administration using biocompatible materials, taking into account skin feel. innovative formulations are prepared for dermal and transdermal administration using biocompatible materials, taking into account skin feel; We develop new study protocols for evaluating efficacy and related cosmetic claims using non-invasive bioengineering devices ranging from simple hydration to volume filling with three-dimensional analysis. We carry out innovative study protocols for analyzing hair and scalp both in vivo and ex vivo. Finally, we assist companies in preparing the documentation for the marketing of the finished cosmetic product, supporting their effectiveness with a wide variety of claims.
For any requests or further information, please contact us:
Prof. Sonia Laneri (slaneri@unina.it)
Preclinical Models in Neuroscience and Gut–Brain Axis Modulation
Thanks to a team of highly qualified researchers and the application of innovative methodologies, the COMPAGINE laboratory stands out for delivering high-quality preclinical studies and experimental research, essential for evaluating the efficacy, safety, and mechanisms of action of novel products and pharmacological compounds in the field of neuroscience.
We specialize in conducting studies using animal models to assess the therapeutic activity of new molecules across a range of central nervous system disorders, including anxiety, depression, and neuropsychiatric conditions such as autism spectrum disorders. Our expertise also encompasses the evaluation of analgesic efficacy in multiple pain models, from acute and inflammatory pain to chronic conditions, including neuropathic pain. We are committed to developing tailored experimental protocols to ensure reliable, reproducible, and high-quality results, in full compliance with ethical and safety regulations. Our flexibility and strong focus on partners' needs enable us to establish effective collaborations, supporting each project from the initial design phase through to data interpretation.
For further information about our expertise or to discuss potential collaboration opportunities, please contact Prof. Roberto Russo at roberto.russo@unina.it.
NutraPharmaLab – Design of Innovative Nutraceutical Formulations
NutraPharmaLab's research focuses on foods and dietary supplements, with the following activities: chemical characterization; in vitro and in vivo preclinical assays to evaluate the efficacy, toxicity, and mechanisms of nutraceuticals; and contribution to the planning of clinical trials. Particular attention is paid to: i) agri-food by-products, as they are rich sources of bioactive compounds of nutraceutical interest, with a view to eco-sustainability and the circular economy; ii) pilot-scale establishment of "biofactories" (microgreens and plant cell cultures) to produce phytocomplexes with high levels of active ingredients, maximum purity, and minimal environmental impact; iii) isolation of exosomes from plant matrices for potential nutraceutical and cosmeceutical formulations.
Companies interested in the services offered are invited to contact: Professor Gian Carlo Tenore, giancarlo.tenore@unina.it; Dr. Maria Maisto, maria.maisto@unina.it; Dr. Roberto Ciampaglia, roberto.ciampaglia@unina.it; and Dr. Vincenzo Piccolo, vincenzo.piccolo3@unina.it.
Interdepartmental Centre for Preclinical and Clinical Research in Sexual Medicin
FROM BENCH TO BEDSIDE: TRANSLATIONAL RESEARCH FOR NEW PHARMACOLOGICAL APPROACHES TO THE GENITO-URINARY TRACT
The Interdepartmental Centre for Preclinical and Clinical Research in Sexual Medicine (CIRMS) places its focus on addressing major scientific and clinical challenges in the field of sexual medicine, with particular attention to the genito‑urinary system. The Centre operates within a strongly multidisciplinary framework, integrating basic, translational, and clinical research through the collaboration of two departments: the Department of Pharmacy and the Department of Neuroscience, Reproductive and Oral Sciences. CIRMS's primary mission is to identify novel therapeutic targets, such as molecules and proteins involved in the pathophysiology of the genito-urinary tract in order to develop innovative treatments and increasingly precise diagnostic biomarkers. Preclinical research is conducted through a comprehensive approach employing both in vitro and in vivo models, working with cells, animal tissues, and human biological matrices to uncover new disease-related targets and biomarkers. Clinical research activities complement this process by translating experimental evidence into clinical practice, intending to improve the diagnosis, management, and treatment of sexual and urogenital disorders. Through its integrated methodology and multidisciplinary expertise, CIRMS plays a strategic role within the scientific community, contributing to the advancement of new pharmacological strategies and diagnostic tools in sexual and urogenital medicine. Organizations and companies interested in collaborating or accessing the services offered by the Centre may contact Prof. Roberta d'Emmanuele di Villa Bianca at the following email address: demmanue@unina.it
IMPACT (ImmunoPharmaLab for Advanced Cellular Therapies)
The ImmunoPharmaLab, directed by Professor Francesco Maione (francesco.maione@unina.it) with Dr. Anella Saviano (RTD-A) as the operational and scientific manager, is an ISO9001-certified laboratory within the Department of Pharmacy at the University of Naples Federico II.
The laboratory focuses on the in-depth study of the molecular, cellular, and biochemical mechanisms underlying inflammatory and immune processes, as well as related pathological alterations, with a specific emphasis on Th1/Th2 and Th17/Treg balances. It possesses advanced expertise in using in vitro, in vivo, and ex vivo preclinical models and employs state-of-the-art technologies, including human scaffolds, 2D and 3D cellular models, flow cytometry, and transcriptomic analysis.
Services for Companies – Preclinical and Clinical Research
ImmunoPharmaLab provides a range of qualified services for pharmaceutical, nutraceutical, and biotech companies, including: i) development and validation of customized preclinical models to test the efficacy and safety of new compounds; ii) screening of molecules with anti-inflammatory and immunoregulatory activity; iii) integrated pharmacological evaluation in collaboration with clinicians and other research groups for translational studies and early-phase clinical trials; and iv) support in defining regulatory strategies for transitioning from preclinical to clinical studies, as well as documentation for regulatory assessment.
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PharmaTechLab
The PharmaTech Laboratory, headed by Professor Agnese Miro, operates under a UNI EN ISO 9001:2015 certified Quality Management System. The laboratory carries out activities in collaboration with partner companies, including:
Quality Control of Dietary Supplements
Aimed at ensuring product quality and protecting consumers, in accordance with the memorandum issued on April 28, 2022 by the Directorate-General for Food Hygiene, Food Safety and Nutrition of the Italian Ministry of Health. The laboratory performs, in particular:
- tablet disintegration testing;
- breaking strength testing;
- friability testing.
Design and Delivery of the Second-Level Master's Degree in Magistral and Officinal Galenic Formulation.
For further information about the services provided, please contact Professor Agnese Miro at:
miro@unina.it
BioChemLab - Sistemi cellulari avanzati per la ricerca preclinica
The ImmunoPharmaLab, directed by Professor Francesco Maione (francesco.maione@unina.it) with Dr. Anella Saviano (RTD-A) as the operational and scientific manager, is an ISO9001-certified laboratory within the Department of Pharmacy at the University of Naples Federico II.
The laboratory focuses on the in-depth study of the molecular, cellular, and biochemical mechanisms underlying inflammatory and immune processes, as well as related pathological alterations, with a specific emphasis on Th1/Th2 and Th17/Treg balances. It possesses advanced expertise in using in vitro, in vivo, and ex vivo preclinical models and employs state-of-the-art technologies, including human scaffolds, 2D and 3D cellular models, flow cytometry, and transcriptomic analysis.
Services for Companies – Preclinical and Clinical Research
ImmunoPharmaLab provides a range of qualified services for pharmaceutical, nutraceutical, and biotech companies, including: i) development and validation of customized preclinical models to test the efficacy and safety of new compounds; ii) screening of molecules with anti-inflammatory and immunoregulatory activity; iii) integrated pharmacological evaluation in collaboration with clinicians and other research groups for translational studies and early-phase clinical trials; and iv) support in defining regulatory strategies for transitioning from preclinical to clinical studies, as well as documentation for regulatory assessment.
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Laboratorio di analisi strumentale
Scientific Director: Prof. Alfonso Mangoni, alfonso.mangoni@unina.it
- Metabolomic and lipidomic studies for the characterization of the complete set of metabolites of an organism through the analysis of biological fluids, tissues, cells, and organs. These studies make it possible to assess biochemical variations in response to external stimuli such as pharmacological treatments and/or the presence of diseases. The ultimate goal is the discovery of biomarkers useful for diagnosing or predicting the onset of diseases or forecasting the response to a treatment. Nuclear magnetic resonance spectroscopy has only recently been applied to this purpose, but it is proving to be one of the most powerful tools for this type of analysis.
- Studies on the structure, dynamics, and interactions of proteins in solution and in the solid state. The use of nuclear magnetic resonance spectroscopy allows highly precise characterization of protein–drug interactions directly in physiological environments such as the cell, cellular membranes, and organelles. The main objective of this research is to develop a rational approach to drug design based on a detailed study of their interactions with target proteins.
- Bioprospecting of the chemodiversity of living organisms for the identification and structural elucidation of new bioactive natural products as leads for new classes of anticancer and anti-inflammatory drugs. Nuclear magnetic resonance spectroscopy is essential for determining the structure of new natural products, which is the prerequisite for any further development of these molecules.