The Italian company Areta International was founded in 1999 as a service provider in the field of cell culture and the latest generation of pharmaceuticals. It now researches and develops new biological pharmaceuticals for advanced cell and gene therapy and tissue engineering. The brainchild of Maria Luisa Nolli, the company now employs 25 people, 90% of whom have University degrees. It is based in the Insubrias Biopark, the first biotechnology park to have originated from cooperation in the Italian-Swiss trans-frontier region of Insurbia. Areta broke even in 2003 and has since continued to invest in new technologies and a good manufacturing practice. Its turnover now stands at 1.5 million Euros: 80% in Italy and 20% in the rest of the world. The domestic market has a strong impact on revenue, although the best prospects for growth remain overseas. We asked Maria Luisa Nolli, the company’s CEO, for more information.

What do you need to become international?

We mainly need time. Areta started its internationalization process only a few years ago. The outlet markets offering the best potential are North America and Europe. As it happens, we are one of very few Italian companies able to develop cutting edge biological pharmaceuticals for advanced therapies.

How do you account for the company’s uniqueness?

Areta’s uniqueness is down to its business model, among other things. The company develops and manufactures special batches according to customer requirements, ideal in the case of biological pharmaceuticals which can be more unstable and less characterized than chemical synthesis ones. We therefore need large production infrastructures, as we manufacture only custom-made batches at the most appropriate stage of developing the pharmaceutical.

How has Areta changed over the years?

When we started up, we simply provided services for the pharmaceuticals sector and research institutes, as in the creation of new antibodies for R&D tests and the determination of proteins in biological fluids. A few years later we realized the great potential in store for the sector of biological pharmaceuticals. An innovative type of pharmaceuticals was fast gaining ground, with new proteins for enzymatic therapy, antibodies for immune therapy and cells for cell therapy. It won’t be long now before biological pharmaceuticals will account for half of all new pharmaceuticals.

When did you take that big step?

When we realized we needed a pharmaceutical plant to produce batches of medicines for clinical trials. This was an attractive challenge for those like me who know the field so well: I came from Lepetit, part of the multinational company Dow Chemical. In the 15 years I worked for Dow Chemical, I gained the experience, know how and skills required to make that all-important step and become an entrepreneur.

Was the transition from researcher to entrepreneur an easy one?

No, certainly not. I know from personal experience that there is a big gap between attaining excellence in research and being able to transform the fruits of experimental research into potential pharmaceuticals. To bridge this gap we at Areta require the professionalism of people such as Luigi Cavenaghi who has also worked for Lepetit and held important roles in “quality operations” for Aventis, among other things. Cavenaghi is now the president of Areta and has brought to the company the expertise in the control and quality assurance required to create batches. His contribution has helped immensely in organizing the production plant that has now been operational since 2004.

What exemplifies your approach to production?

Areta’s innovation lies in the fact that its GMP plant features not fixed fermentation plants but modular, disposable sterile bio-reactors which are ideal for creating biological pharmaceuticals from cell cultures, and guarantee the required sterility. Biological pharmaceuticals require even higher standards of sterility than traditional production methods. In 2008, we inaugurated a new plant and also put our talents to antibodies, recombinant proteins and cells for regenerating tissue.

How will you continue to expand?

With regard to developing pharmaceuticals, we are currently applying ourselves in the process from basic research to the creation of batches for phase 1 and 2 clinical tests. Our strategy initially involved consolidation in Italy. Now is the time to open our doors to the foreign markets, which is precisely what we are doing at the moment. 2007 was a decisive year in that respect with the Austrian company Cyathus Exquirere’s break in the capital.

What will your next move be?

We work with staminal cells to reconstruct bone tissue and the myocardium. We are also involved in European and international research projects aimed at developing innovative pharmaceuticals. The hope is to ensure their future development by applying our team and joining consortiums.