Famed for its architecture, cuisine, art and fashion, Italy’s export-oriented economy is hugely reliant on the agricultural sector which accounts for about 2% of the country’s gross domestic product (GDP). A major player in the pharmaceutical industry, Italy also has a steady biotech industry, with a constantly growing number of companies.
As more than 85% of the biotech industry’s revenue is focused in the regions of Lombardy, Lazio, and Tuscany, according to 2019 statistics, the biotech industry in Italy amounts to more than €11 billion ($11.8 billion). With more than 400 research and development (R&D) dedicated firms in the country, the biotech sector has evolved over the years, while 50% of the industry is dominated by healthcare. Leading the industry in 2020 was therapeutics company Menarini – making a profit of €3.9 billion ($4.2 billion) – followed by biotechs Chiesi Farmaceutici and Angelini.
As Italy celebrates its Republic Day on June 2, here are six companies that are key to the Italian biotech industry.
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The concept of reverse vaccinology has been documented since the 1990s. Relying on the principle of cloning and protein expression in an organism’s genome sequence, the technology has been used in the creation of a vaccine against meningococcus – a bacterium that causes meningitis. Now, AchilleS Vaccines is employing this technology to develop vaccines against malaria.
Located in the vaccine hub of Siena in Italy, the biotech company leverages bioinformatics and artificial intelligence in its next generation reverse vaccinology (NGRV) platform. Additionally, the company is developing vaccines based on modified outer membrane vesicles (mOMV). Outer membrane vesicles (OMV) contain phospholipids, lipopolysaccharide, outer membrane proteins and entrapped soluble periplasmic components, and have demonstrated immunogenicity as vaccines in animal and human models.
In its pipeline, AchilleS Vaccines is developing MAbCo19, a monoclonal antibody against the acute respiratory syndrome SARS-CoV-2. B cells from people with COVID 19 will be selected as they are capable of producing antibodies. Currently in development along with its malaria vaccines, the company received €17.6 million ($18.9 million) from the EU Malaria Fund for the vaccination project.
In April, the company entered a partnership with AI-based drug development company InSilicoTrials to utilize the latter’s InSilicoVACCINE Suite for the production of mOMV.
One of the largest cosmetics markets in the world, Italy is a major player in the lifestyle and beauty industry in Europe. And elemental to this industry in Italy is Arterra Bioscience. Based in Naples, Italy, the biotech company derives eco-sustainable active ingredients from plant cell cultures and food by-products.
By examining the skin’s physiology through the measurement of genes and proteins for its proper functioning, the company looks into the effect of active ingredients on skin cells. It focuses on processes such as hydration, strengthening of the extracellular matrix, defense against oxidative stress and skin aging for the development of its formulations. The biotech has an ex vivo assay platform that is based on the manipulation of skin explants and the cryopreservation of the explants, where it analyzes how specific proteins change in accordance with treatment. The company does this analysis through in vitro skin models.
Moreover, it has developed platforms that screen gastric, intestinal, neuronal, immune and epidermal cell lines, using which the identification of new compounds is made possible. It has also created in vitro intestinal models that are based on co-cultures of various human cell lines to reproduce intestinal epithelium. This is done to recognize how different molecular mechanisms are linked to certain diseases. With a varied portfolio of products, the company also focuses on measures that enhance the assimilation of nutrients and strengthen the defense against factors like stress and pathogens in the field of agriculture.
The company’s growth chambers grow plant cultures in a controlled environment. Depending on whether it is for the pharmaceutical or food sector, the products are extracted, which begins with obtaining biomass from the cultures. The product is then sterilized and packaged for commercialization.
Last year, the company, which was founded in 2003, obtained funding and concession grants worth $1 million for its upcoming SmartLAB project, which is based on RNA technology for agriculture.
Established in 2011, EVERGREENBIOS is a biotech that focuses on ecosymbiotic agriculture, the sustainable environment, biogas production and animal welfare. Situated in Lombardy in Northern Italy, the biotech company specializes in the production of microbes through techniques like submerged fermentation (SmF) and solid state fermentation (SSF), mechanisms that use a solid substrate and a liquid medium respectively, to grow microorganisms.
Using industrial fermenters, the company is able to produce around 40 tons of microbial cultures of fungi, bacteria and spore-forming bacteria and their specifically produced metabolites, a month, via SmF. For SSF, it has a plant that consists of 1,000 bioreactors containing the solid support. This method is suitable for the production of enzymes and fungi. The cultures that are obtained from fermentation undergo processes such as ultrafiltration, disintegration after which specific biological substances are added to stabilize them. Finally, different kinds of formulations are derived, including those in the form of liquids, granules and micronized powders.
The company has its own strain library that comprises microorganisms with specific characteristics. These strains are tested for the production of enzymes and their ability to interact with hormonal systems of plants are investigated. EVERGREENBIOS is also conducting research in the field of bio batteries.
Woven from the fibers produced by silkworms, silk is a versatile material that has properties that are advantageous in the field of medicine. Used as a biomaterial, it can be developed in the form of gels, sponges and films, and even chemically modified to alter its surface properties through molecular engineering. Harnessing the potential of its many applications, KLISBio, headquartered in the growing biotech hub of Milan, is making progress in regenerative medicine.
The company’s technology platform SILKBridge is an absorbable medical device that is made from the fibroins – the protein present in silk – of Bombyx mori worms. Ensuring ideal porosity and compression resistance, the product is being developed to promote nerve regeneration and recovery during wound healing. The inner and outer electrospun layers have been designed for quicker absorption and improved cell adhesion. These layers mimic nanoscale properties of fibrous components of the extracellular matrix – which consists of proteins and other molecules that support the tissues – to enhance cellular interactions. The textile layers in between are modeled in open-mesh braided structures to boost mechanical performance.
While it is yet to receive clearance from the U.S. Food and Drug Administration (FDA), the company is advancing its studies, where its silk-based composites are undergoing preclinical studies for bone grafting. As for the silk regenerated fibroin, the company’s most advanced indication is for nerve repair, which is expected to launch in the U.S. in 2024. The biotech is also investigating its product for vascular grafting and rotator cuff repair, for which the former is in preclinical trials and the latter is in its proof of concept stage.
Set up in 2014, KLISBio has secured a total of €10.6 million ($11.3 million) over four financing rounds. The latest round took place in 2021, with Italian venture capital Principia SGR as its lead investor.
Renowned for its Renaissance art and vineyards, Tuscany is also home to a growing life science sector. And Next Genomics is at its forefront with emphasis in precision medicine among other fields. The company’s Gene Home offers a complete sequencing of the genome. Genome sequencing is often done to better understand one’s DNA and flag the possible onset of genetic diseases.
The company also conducts microbiome tests and provides personalized dietary advice based on the results. The gut microbiome is a complex environment and of late, studies have proven its disruption being linked to various other diseases like the neurodegenerative disease Parkinson’s. As some scientists even refer to the microbiome as the second genome, Next Genomics tests for food allergies and studies the intestines through its microbiome analysis. The Symbyo tests – which inspects the microflora in the gut, skin, vagina, mouth, eyes, nose and urine – provides an analysis of the bacterial community. The company also provides guidance on prebiotics, probiotics and supplements to nourish a healthy microbiome environment.
Furthermore, the Italian biotech company analyzes plant pathology as well as engages in integrated pest management. It also monitors the environment for glyphosate on bees – which has a harmful impact on their development – and in surface waters in the municipality of Carmignano.
An indispensable tool for detecting infections, polymerase chain reaction (PCR) tests are central to molecular diagnostics. Headquartered in the city of Udine in the north-eastern region of the country, Ulisse BioMed’s PCR platform Sagitta develops diagnostic kits that do not require pre-treatment for extracting RNA and DNA, making the process cheaper and quicker. The tests can detect the presence of human papillomaviruses as well as sexually transmitted infections and coronavirus.
Besides Sagitta, the company has its NanoHybrid platform – with performance similar to that of an ELISA test – for the detection of antibodies in blood by means of fluorescent nanosensors, and consumes low amounts of plastic for its production. The biotech also has the Aptavir platform which focuses on the identification and production of antiviral aptamers – genetic material that can bind to a specific target – for diagnostic and therapeutic purposes.
In February, the Italian biotech company, which was founded in 2015, announced its collaboration with Italian diagnostics company ELITechGroup for the global distribution of ELITechGroup’s HPV detection tests that were built using the Sagitta platform.