EuroBiotech_Mr Molero, in the past four years, 3P Biopharmaceuticals has demonstrated tremendous growth above the average CGAR for CDMOs. So far, 3P Biopharmaceuticals’s portfolio was offered to European clients. What can you tell us about the company’s recent expansion to the US market?
Molero_We will be growing more than 40 per cent this year and significantly more than 10 per cent in the following years. The reason for why we are currently more involved in the European market, where we make 80 per cent of our revenues, is because we are a Europe-based company; so, we have grown here, as it is our natural and closest market. Thus, we have only had little time for a geographic expansion to the US, and now, it is the perfect time to extend and increase our growth in the US-American market. In fact, recently, we signed a contract with US company Zhittya Genesis Medicine for the manufacturing of clinical supplies of human FGF-1, and we also received the FDA approval for producing commercial supplies for Calcivis, a British customer. However, after having consolidated our European activities and business, we want to build our own presence in the US as soon as possible. Currently, we don’t know if we will do so through a joint-venture with a US bioprocessing company or through an investment to build own capacities. Either in Europe, where our company was founded 13 years ago, or in the US, 3P Biopharmaceuticals will remain focused on process development and cGMP manufacturing of biologics using microbial and mammalian expression systems and cell therapy products along the whole value chain. That’s – in brief – the global strategy we want to implement.

EuroBiotech_Strategically, what is 3P
Biopharmaceuticals’s advantage over other CDMOs?
Molero_Taken 3P Biopharmaceuticals‘s relatively small size – we currently have 270 staff – the company has built expertise in a tremendously broad portfolio of different technologies and know-how. We offer solutions for biologics at all stages of product development: from early stages up to commercial supply. We are also very flexible in serving the needs of our customers by combining the best technologies available in the market, so as to set up a process that can be freely transferred to any site in the world, without paying any licence fees, because primarily, we can carry out process development without using patent-protected production cell lines’ manufacturing process and technology. We work closely with, and not for, our clients to solve all problems that might occur in process development.

EuroBiotech_3P Biopharmaceuticals most recently expanded and modernised its analytical, microbial, and mammalian cell production capacities for such different formats as recombinant proteins, antibody conjugates, vaccines, and allogenic cell therapy products, such as cardiac stem cells. What’s the basis for this and future expansion, and where do you want to go?
Molero_We modernised analytical and manufacturing capacities, investing €9m during 2018 – 2019, and we are going to triple our revenues, capacities, and staff by 2025. Our new investment plan foresees €17m for further investments in capacity expansion with existing technologies: microbial and mammalian cell manufacturing and cell therapies.

EuroBiotech_What are your strategic goals for the next year, and what’s your shareholder’s role in achieving them?
Molero_Since July, we have Keensight Capital as our new major shareholder. We were very satisfied with the support from our former shareholder Infarco, who recently refocused its strategic business. As we now are in the stage of company expansion and internationalisation, our business needed appropriate know-how and found it with Keensight Capital, who will support us in expanding our core facility and setting up potential new ones in Europe and abroad. Besides that, we have continuous commitment from Sodena, our local governmental agency.

EuroBiotech_What is your expectation for future development of the CDMO market/market consolidation and promising directions concerning therapy formats?
Molero_Advanced therapies are a stra­tegically important field to develop in the future. We have some experience in process development but will implement that more broadly in the next deve­lopment phase, in one to two years. Generally, the CDMOs, as we know them today, have to build more capa­cities and to make existing processes more efficient in order to reduce costs drastically. This is particularly true for ATMPs, where prices are skyrocketing, due to autologous cell therapy set-up. Current prices are a challenge for health systems and society and have to be reduced.

t.gabrielczyk(at)biocom.eu

first published in European Biotechnology Winter Edition 2019