Famous for architecture, cuisine, art and fashion, Italy’s export-oriented economy is heavily dependent on the agricultural sector which accounts for around 2% of the country’s gross domestic product (GDP). As a major player in the pharmaceutical industry, Italy also has a strong biotech industry, with a growing number of companies.
Because more than 85% of the biotech industry’s revenue is focused on the Lombardy, Lazio and Tuscany regions, according to statistics 2019, the biotech industry in Italy amounts to over €11 billion ($11.8 billion). With more than 400 research and development (R&D) firms in the country, the biotechnology sector has grown over the years, while 50% of the industry is dominated by healthcare. Leading the industry in 2020 will be therapeutics company Menarini – making a profit of €3.9 billion ($4.2 billion) – followed by biotechnology Chiesi Farmaceutici and Angelini.
As Italy celebrates Republic Day on June 2, here are six companies that are key to the Italian biotechnology industry.
The concept of reverse vaccinology has been documented since the 1990s. Relying on the principle of cloning and protein expression in the genome sequence of organisms, the technology has been used in the manufacture of vaccines against meningococcus – the bacterium that causes meningitis. Now, Achilles Vaccine is using this technology to develop a vaccine against malaria.
Located in the Siena vaccine center in Italy, the biotechnology company is leveraging bioinformatics and artificial intelligence in its next-generation reverse vaccinology (NGRV) platform. In addition, the company is developing a vaccine based on a modified outer membrane vesicle (mOMV). Outer membrane vesicles (OMV) contain phospholipids, lipopolysaccharides, outer membrane proteins, and soluble, trapped periplasmic components, and have demonstrated immunogenicity as vaccines in animal and human models.
In its tracks, the AchilleS vaccine is developing MAbCo19, a monoclonal antibody against acute respiratory syndrome SARS-CoV-2. B cells from COVID-19 sufferers will be selected because they are capable of producing antibodies. Currently in co-development with its malaria vaccine, the company received €17.6 million ($18.9 million) from the EU Malaria Fund for a vaccination project.
In April, the company entered into a partnership with AI-based drug development company InSilicoTrials to leverage the latest InSilicoVACCINE Suite for mOMV production.
As one of the largest cosmetics markets in the world, Italy is a major player in the lifestyle and beauty industry in Europe. And an element of this industry in Italy is Arterra Bioscience. Based in Naples, Italy, this biotech company obtains eco-friendly active ingredients from plant cell cultures and food by-products.
By examining skin physiology through measuring genes and proteins for their proper functioning, the company looks at the effect active ingredients have on skin cells. It focuses on processes such as hydration, extracellular matrix strengthening, defense against oxidative stress and skin aging for its formulation development. Biotech has an ex vivo assay platform based on manipulation of skin explants and explant cryopreservation, where it analyzes how specific proteins change according to treatment. The company performed this analysis via an in vitro skin model.
In addition, he has developed a platform that screens gastric, intestinal, nervous, immune and epidermal cell lines, enabling the identification of novel compounds. It has also created an in vitro intestinal model based on co-culture of various human cell lines to reproduce intestinal epithelium. This is done to recognize how different molecular mechanisms are related to certain diseases. With a diverse product portfolio, the company also focuses on measures that increase nutrient assimilation and strengthen defenses against factors such as stress and pathogens in agriculture.
The company’s growth room grows plant cultures in a controlled environment. Depending on whether it is for the pharmaceutical or food sector, the product is extracted, which starts with obtaining the biomass from the culture. The product is then sterilized and packaged for commercialization.
Last year, the company founded in 2003 secured $1 million in funding and a concession grant for its upcoming SmartLAB project, which is based on RNA technology for agriculture.
Founded in 2011, EVERGREENBIOS is a biotech focused on ecosymbiotic agriculture, sustainable environment, biogas production and animal welfare. Located in Lombardy in Northern Italy, the biotech company specializes in the production of microbes through techniques such as submerged fermentation (SmF) and solid state fermentation (SSF), mechanisms that use solid substrates and liquid media respectively, to grow microorganisms.
By using industrial fermenters, the company is able to produce about 40 tons of specially produced microbial cultures of fungi, bacteria and spore-forming bacteria and their metabolites, a month, via SmF. For SSF, his party has a plant consisting of 1,000 bioreactors filled with solid support. This method is suitable for the production of enzymes and fungi. Cultures obtained from fermentation undergo processes such as ultrafiltration, disintegration after certain biological substances are added to stabilize them. Eventually, various types of formulations were derived, including liquids, granules, and micron powders.
The company has its own strain library consisting of microorganisms with certain characteristics. These strains were tested for enzyme production and their ability to interact with the plant’s hormonal system was investigated. EVERGREENBIOS is also conducting research in the field of bio batteries.
Woven from the fiber produced by silkworms, silk is a versatile material that has medicinal properties. Used as a biomaterial, it can be developed into gels, sponges and films, and even chemically modified to change its surface properties through molecular engineering. Harnessing the potential of its many applications, KLISBio, headquartered in a growing biotech center in Milan, is making progress in regenerative medicine.
The company’s SILKBridge technology platform is an absorbable medical device made from fibroin – a protein found in silk – from Bombyx mori worm. Ensuring ideal porosity and compression resistance, these products are being developed to promote nerve regeneration and recovery during wound healing. The inner and outer electrospun layers have been designed for faster absorption and better cell adhesion. These layers mimic the nanoscale properties of the fibrous components of the extracellular matrix – which is made up of proteins and other molecules that support tissues – to enhance cellular interactions. The textile layers in between are modeled in an open mesh braided structure to improve mechanical performance.
Although it has yet to receive a permit from the US Food and Drug Administration (FDA), the company is advancing its studies, whereby silk composites are undergoing preclinical studies for bone grafting. As for fibroin regeneration silk, the company’s most advanced indication is for nerve repair, which is expected to launch in the US in 2024. Biotech is also investigating its products for vascular grafting and rotator cuff repair, which were previously in preclinical stages. trial and the latter in the proof-of-concept stage.
Founded in 2014, KLISBio has raised a total of €10.6 million ($11.3 million) over four financing rounds. The final round is taking place in 2021, with Italian venture capital Principia SGR as its lead investor.
Famous for Renaissance art and its vineyards, Tuscany is also home to a thriving life sciences sector. And Next Genomics is at the forefront with an emphasis on precision medicine among other fields. The company’s Gene Home offers complete genome sequencing. Genome sequencing is often done to better understand a person’s DNA and flag possible 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 recent studies have shown its disruption to be linked to other diseases such as the neurodegenerative Parkinson’s disease. Because some scientists even call the microbiome a second genome, Next Genomics tests food allergies and studies the gut through analysis of its microbiome. The Symbyo test – which examines 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 maintain a healthy microbiome environment.
Furthermore, Italian biotech companies analyze plant pathology as well as engage in integrated pest management. It also monitors the environment for glyphosate in bees – which have harmful effects on their development – and in surface waters in the municipality of Carmignano.
An indispensable tool for detecting infection, the polymerase chain reaction (PCR) test is central to molecular diagnostics. Headquartered in the city of Udine in the northeastern region of the country, Ulisse BioMed’s Sagitta PCR platform develops diagnostic kits that do not require pre-treatment to extract RNA and DNA, making the process cheaper and faster. The test can detect the presence of the human papillomavirus as well as sexually transmitted infections and coronaviruses.
In addition to Sagitta, the company has a NanoHybrid platform – similar in performance to an ELISA test – to detect antibodies in blood via nano fluorescent sensors, and uses small amounts of plastic for their production. Biotech also has an Aptavir platform focused on identifying and producing antiviral aptamers – genetic material that can bind to specific targets – for diagnostic and therapeutic purposes.
In February, the Italian biotechnology company, founded in 2015, announced its collaboration with Italian diagnostic company ELITechGroup for global distribution of ELITechGroup’s HPV detection test built on the Sagitta platform.