Welcome to
SNOW BIOTECH
|
We are an Italian company based in Montella AV (Italy), engaged in Research, Development, Production and Commercialization of innovative pharmaceutical products in the respiratory field, particularly for rhinosinusitis.
Our strength is to possess someunique pharmaceutical products, characterized by efficacy and safety in their use, all proven with relevant clinical studies.
Welcome to
SNOW BIOTECH
|
We are an Italian company based in Montella AV (Italy), engaged in Research, Development, Production and Commercialization of innovative pharmaceutical products in the respiratory field, particularly for rhinosinusitis.
Our strength is to possess someunique pharmaceutical products, characterized by efficacy and safety in their use, all proven with relevant clinical studies.
Our Mission and Vision
We are committed to developing innovative pharmaceutical products, preferring raw materials of plant origin or endogenous to the human body, with great attention to sustainability and safeguarding human, animal and environmental well-being.
Diagnostic Algorithms
privacy
innovation
sustainability
telemedicine
medicine of the future
Medicine of the Future
We believe that the medicine of the future must integrate new digital technologies with innovative pharmaceutical products, focused imperatively on efficacy, safety and sustainability.
Innovation
We do not like to be ordinary; our research and development department works daily to develop innovative, safe and effective products, always integrating multiple disciplines to achieve excellent results.
Diagnostic Algorithms
The physician's diagnosis will have to be increasingly supported by elaborate diagnostic algorithms capable of instantly assessing every possible etiopathological and evolutionary variable of the disease.
Telemedicine
Like diagnosis, drug therapy will also need to be assisted through telemedicine, so that each patient feels followed 24 hours a day, 365 days a year.
Sustainability
The active ingredients we produce in-house come from our organic, above-ground cultivation (hydroponic cultivation), where no phytosanitary treatment is carried out, but only organically produced nutrient solutions are used.
Privacy
Privacy is certainly an inviolable right; nevertheless, data analysis is indispensable for developing diagnostic and therapeutic algorithms to support the physician and certainly to benefit the patient.
the company at a glance |
the company at a glance |
THE MANAGEMENT. |
We are a small
but well-structured company,
equipped with management with long experience in the role.
THE MANAGEMENT. |
We are a well-structured young company,
equipped with management with long experience in the role held.
[ Nevia Biotech SA, Switzerland ]
CEO / R&D Manager
[ Nevia Biotech SRL, Italy ]
Best CEO in the pharmaceutical industry 2022
🏆 The Sources Awards 2022 🏆
Category: #HEALTHCARE & #PHARMA
Best CEO in the pharmaceutical industry 2022
🏆 The Sources Awards 2022 🏆
Category: #HEALTHCARE & #PHARMA
[ Nevia Biotech SRL, Italy ]
[ Nevia Biotech SRL, Italy ]
[ Nevia Biotech SRL, Italy ]
THE GROUP'S LOCATIONS |
We have two locations, one in Lugano (Switzerland), the second in Montella AV (Italy).
THE HEADQUARTERS OF THE GROUP |
We are based in Montella AV (Italy).
- Production
- Quality control
- Distribution
- Administration
- Direction
- Marketing and sales
- Quality Management
- Research and Development (design)
In the Montella facility, the production departments are our little jewels, where everything takes shape and is transformed into excellent products, both in terms of quality and, above all, safety and effectiveness.
For the manufacture of our products we start from ZERO, so from the production of the active ingredient to the finished product ready to be sold.
HEADQUARTERS.
Nevia Biotech S.r.l.
Via Piedipastini 14-24
83048 Montella (AV) Italy
OPERATIONAL HEADQUARTERS.
Nevia Biotech S.r.l.
Via dei Vignali
83048 Montella (AV) Italy
OUR DEPARTMENTS |
Our production chain closed entirely on the farm, beginning with the cultivation of the plant that produces the active ingredients and ending with the product ready for sale
OUR DEPARTMENTS |
Production chain closed entirely on the farm, the production cycle begins with the cultivation of the plant that produces the active ingredients and ends with the product ready for sale.
Seed Germination
Incubation
Our production process begins with the cultivation of the herbaceous plant (Ecballium Elaterium) from which we extract the basic active ingredients of our products indicated in the therapy of rhinosinusitis. The plant is raised from seed that is incubated in germination cells, where the following are constantly monitored: temperature, humidity, light, and amount ofCO2
Transfer
After germination, the young seedlings remain in the germination cells until they are ready to be transferred to the greenhouse
THE GREENHOUSE
Automation
We have a fully automatedglass greenhouse nestled in a beautiful green area of about 23,000 square meters.
Its technology is state-of-the-art; temperature, humidity and light management are controlled through environmental sensors that monitor the same parameters 24 hours a day.
Special software controls the operation of all devices that contribute, each for its part, to maintaining the preset environmental conditions in the greenhouse.
The main devices include:
- The opening and closing of side windows and on roof pitches,
- The opening and closing of shading nets, both under and over pitch
- The operation of the ventilation and cooling system using geothermal energy
- the lighting system.
Hydroponic Cultivation
Plants are raised with state-of-the-art hydroponic system controlled by special software that independently monitors and manages the delivery of nutrient solutions, these differently compounded according to the seedlings’ growth period and preset in advance. The operator’s role is critical, but it is limited to ensuring that the plant has all the components to form the nutrient solutions.
The attainment of fruit ripeness is monitored with constant laboratory analysis, aimed at verifying the maximum concentration of active ingredients present in the same fruits.
EXTRACTION AND PURIFICATION ROOM
Extraction room
raw active ingredients
Ecballium Elaterium fruits (peponidia) produced in the greenhouse, after harvesting
are transferred to our production unit and stored in cold storage at a temperature of +4°C until their processing begins
, which takes place within a maximum of 48 hours after harvesting.
The fruits are washed with the help of a fully automatic washing machine with a preset washing cycle, and then subjected to rondellation (disc cutting) and then raw extraction of the active ingredients.
This extraction takes place with the help of a fully automated extraction plant without the use of chemical solvents, simply by exploiting physical principles such as temperature and pressure.
Active ingredient purification room
After extraction, the active ingredients undergo a series of processes in order to concentrate them into a minimal amount of solution, and then
be purified using a state-of-the-art preparative chromatography system.
.
The purified active ingredients, are lyophilized and sealed in glass vials, and then
be stored at a temperature of -60°C
in special refrigerator.
BULK PREPARATION AREA
Our company, producing pharmaceutical products in solution and suspension,
has a liquid bulk preparation area;
this consists of a weighing room and a dissolving room.
Weighing room
The weighing room is where the active ingredients and excipients in the product formula are weighed before being mixed and dissolved (or dispersed) in water.
Weighing operations are carried out under a laminar flow hood to prevent possible contamination.
Dissolvers Hall
After weighing, the active ingredients and excipients are transferred to the dissolving room where the solutions or suspensions based on the manufactured drug products, i.e., bulk, are prepared.
Bulks are prepared in a special fully automated dissolver made of AISI 316 steel.
Specifically, the dissolver automatically draws the exact amount of purified water needed, manages dissolution temperatures, controls pH, electrical conductivity and bulk temperatures, and operates and regulates magnetic stirring of the liquid until the active ingredients and excipients are completely dissolved or dispersed.
Important note to highlight concerns the asepticity of the entire bulk production process, in fact, at all stages of the process, active ingredients, excipients and water are never in contact with air, this in order to prevent any kind of external contamination despite the fact that the air in the production environments is filtered up to 30 times in an hour with absolute filters.
WATER AND CIP ROOM
An area pertaining to the bulk preparation area is the water and CIP room,
where purified water based on the manufactured pharmaceutical products is produced and where
the automatic washing and sanitizing system for bulk production and distribution equipment resides.
Water Hall
The purified water production plant is highly sophisticated and capable of producing water that is almost completely free of mineral salts and other elements, both chemical and biological, thus water composed essentially ofH2O, with an electrical conductivity of far less than 1 mS/cm.
The system consists of the following parts:
- pre-treatment filter with quartz sands
- Pretreatment filter with resins and quartz sands
- pre-treatment filter with activated carbon
- 5 mm precision filter
- double-stage reverse osmosis system
- EDI electrodeionization system
- UV sterilization system
- pasteurization system
- ozone sterilization system
- Continuous TOC monitoring (Total Organic Carbon analyzer)
- Controlling pH, electrical conductivity, pressures, flows and temperatures at each stage of water purification
- software for fully automated management of the entire purification process.
CIP Hall
Regarding the Clean-In-Place (CIP) system, this is a system that fully automatically manages the washing and sanitization of bulk production and distribution facilities, including the dissolver.
The system consists of the following parts:
- High-temperature water production and storage tank
- Dissolver for the preparation and storage of solutions with acids
- Dissolver for the preparation and storage of alkaline solutions
- System of adduction of washing and sanitizing solutions to the various utilities
- Sensors for continuous control and monitoring of pH, electrical conductivity, pressures, and flows at each stage of CIP
Nasal and oropharyngeal spray production area
The production area of nasal and oropharyngeal sprays
is essentially composed of two distinct areas:
the primary packaging room and the secondary packaging room.
Primary packaging room
A state-of-the-art multiridose bottle filling and capping plant is installed in the primary packaging room, connected to the dissolution plant through a complex bulk adduction system.
The plant is capable of fully autonomous production of about 3,000 bottles/hour, with the ability to work 24 hours a day.
The system automatically picks up bottles, pumpettes, and caps, fills bottles with solutions or suspensions, inserts and screws nasal or oropharyngeal spray pumps onto bottles, measures the amount of liquid filled into bottles through dynamic weighing, and discards bottles at each stage of production if they do not meet preset specifications.
The entire plant is managed by sophisticated software that can monitor and regulate every stage of production in perfect autonomy.
The operator’s role is critical, but he or she merely supervises and ensures that the plant has the necessary amount of all components.
Secondary packaging room
After the inflating and capping stages, the nasal or oropharyngeal sprays are continuously transferred to the secondary packaging room through a delicate conveyor belt system. Here they are labeled by affixing the variable data (lot and expiration) on the label, placed in the carton along with the package insert, and again coded with the variable data on the carton. Each stage, in addition to being fully automatic, consists of numerous in-line controls; in fact, the entire production line is equipped with dozens of fiber-optic sensors and cameras that continuously capture data and images, all in order to ensure that each step is accomplished accurately and on time. If the slightest imperfection or dissimilarity of the product from what was preset in the management software is detected, the product will inevitably be discarded, all to ensure the highest quality of the packaged product.
the warehouse
Warehouse
The warehouse is divided into several clearly identified and distinct areas,
in particular:
- incoming and outgoing goods area
- quarantine area
- compliant products area
- non-conforming products area
- rejected products area
QUALITY CONTROL
Quality control laboratory
The products are controlled at every stage of production and storage, this is thanks to a state-of-the-art and sophisticated chemical quality control laboratory where state-of-the-art instruments and equipment are present.
RESEARCH AND DEVELOPMENT |
Innovative products already on the market, and others under development or in clinical trials.
RESEARCH AND DEVELOPMENT |
Innovative products already on the market, and others under development or in clinical trials.
Research and Development
The beating heart of Nevia Biotech
The research and development area is the beating heart of our pharmaceutical company. Almost all of the products on the market, in fact, come from the company’s research and development, focused mainly on creating new drugs in rheumatology and neuropsychiatry, as well as, of course, in the respiratory field.
At present, Nevia Biotech has some very important research and development projects, such as:
- Development of a new pharmaceutical product for the treatment of non-allergic cell-mediated rhinitis Nares, Narma, Narne, Naresma(the only product in the world specifically for the treatment of these nosological entities)
- Development of new drugs for the treatment of pre-eclampsia, fibromyalgia and A.D.H.D.
Clinical Research
CiliaCell, a unique product for rhinosinusitis and otitis
The most important products in our company list at the moment are those of the CiliaCell line , which are specific and unique in the world for the treatment of rhinosinusitis corniche and otitis media effusive, both in adults and pediatric age.
Several clinical studies have already been conducted for these products and published in top scientific journals in the field.
The R&D Pipeline
of our pharmaceutical company.
The Research and Development Pipeline of our pharmaceutical company includes several therapeutic areas, such as:
Respiratory, Rheumatology, and Child Neuropsychiatry.
Non-allergic vasomotor rhinitis, among chronic rhinopathies, represents an area…
Attention Deficit Disorder with Hyperactivity Disorder (ADHD, an acronym for the English…
The word fibromyalgia (FM) comes from the Latin fibre, which stands for the tissues…
OUR
LOCATIONS
VIGANELLO (LUGANO) SWITZERLAND
Nevia Biotech SA
Via Luganetto, 4
6962 Viganello (Lugano) Switzerland
MONTELLA (AV) ITALY
Nevia Biotech S.r.l.
Via Piedipastini 14-24
83048 Montella (AV) Italy
Nevia Biotech S.r.l.
Via dei Vignali
83048 Montella (AV) Italy
CERTIFICATIONS AND AUTHORIZATIONS |
Continuous updates in compliance with present regulations
CERTIFICATIONS AND AUTHORIZATIONS |
(Drugs, Medical Devices, In Vitro Diagnostics, Dietary Supplements)
ISO 9001-2015
ISO 13485 – 2022
Swissmedic Authorization No. 512731-102675648
for the following activities:
– Imports of medicaments
– Wholesale trade of medicaments
– Export of medicaments
– Foreign trade of medicaments
Licensing for production of medical devices
containing active substances
TRADE
WHOLESALE
DRUGS
Nevia Biotech is a pharmaceutical company licensed by Swissemedic for:
- Imports of medicines
- Wholesale of medicines
- Export of medicines
- Foreign trade in medicines
We are able to source and supply any kind of drugs globally, including: drugs lacking in different countries, orphan drugs, oncology drugs, vaccines, chemotherapeutics, etc.
DOWNLOAD DRUG LIST
By way of example, but not exhaustive, the list of drugs we can provide: see drug list
TRADE
WHOLESALE
DRUGS
Nevia Biotech is a pharmaceutical company licensed by Swissemedic for:
- Imports of medicines
- Wholesale of medicines
- Export of medicines
- Foreign trade in medicines
We are able to source and supply any kind of drugs globally, including: drugs lacking in different countries, orphan drugs, oncology drugs, vaccines, chemotherapeutics, etc.
DOWNLOAD DRUG LIST
By way of example, but not exhaustive, the list of drugs we can provide: see drug list