
David Short Sr. Manager, Business Development - US & Canada
PROCOS SPA
"Supporting companies while managing the uncertainties in funding and timelines is key to fostering long-term, successful partnerships."
How will the new R11 manufacturing facility enhance production capacity and meet growing market demands?
With its building shell complete and equipment installation underway, the facility will feature 20 reactors across four multi-purpose production lines, offering capacities from 1,000 to 6,000 L. This expansion will add 73 cubic meters of production capacity, targeting high-value, complex molecules, particularly in clinical development stages. Scheduled for full qualification by late 2025 or early 2026, the R11 facility will increase overall manufacturing capacity by 25%. For US clients, it will provide flexible mid-scale production tailored to smaller volumes, and specialized therapeutics, ensuring a more robust, diversified and geographically redundant supply chain. How does Procos differentiate itself from other API manufacturers?
We specialize in custom synthesis, offering tailored solutions for emerging therapies that require highly specialized APIs. Our advanced R&D capabilities, combined with a strong manufacturing capacity and a collaborative approach, enable us to meet client demands efficiently and cost-effectively. This flexibility allows us to support clients in diversifying their supply chains while maintaining high-quality standards. What strategies does the firm deploy to ensure supply chain reliability?
Procos ensures supply chain reliability through a comprehensive business continuity plan that proactively identifies potential risks and mitigates disruptions, enabling seamless operations and timely deliveries. We maintain long-term, trusted partnerships with key suppliers and continuously optimize our procurement and production processes. Our established global supplier network supports both generic API production and custom synthesis projects, enhancing flexibility and resilience. How does Procos navigate regulatory challenges as an API manufacturer?
We adhere to the highest compliance standards in North America, Europe and Japan by working closely with regulatory agencies to anticipate and adapt to evolving industry requirements. Our in-depth expertise in generic APIs allows us to navigate complex regulatory landscapes, ensuring full compliance while fostering productive collaborations with authorities. This dual focus on operational efficiency and regulatory excellence empowers Procos to deliver consistent, high-quality products to clients worldwide.
We continually invest in state-of-the-art facilities and ensure they meet or exceed regulatory expectations. This commitment to quality enhances our reputation as a trusted partner, especially in North America, where regulatory oversight is tightening. By prioritizing quality, we open opportunities for collaborations with leading pharmaceutical companies, positioning us to remain competitive in a rapidly changing regulatory environment. What steps is Procos taking to minimize its environmental footprint?
We are committed to reducing our environmental impact through investments in energy-efficient technologies, waste reduction, and sustainable sourcing practices. Our R&D team plays a vital role in optimizing manufacturing processes for maximum efficiency, which not only ensures high production standards but also contributes to a greener future. We are preparing our first sustainability report, scheduled for release in 2026. How does Procos adapt to the evolving needs of biotech firms?
Biotech firms are often at the forefront of cutting-edge medicine, requiring specialized manufacturing processes for complex molecules. Procos supports these companies by developing tailored processes to meet their unique needs. We work closely with smaller biotech firms, offering flexibility in adapting our services to their specific requirements. Our expertise enables us to assist in the development of critical components for advanced therapies, ensuring we meet the increasing demands of the specialized drug market. What are the challenges of partnering with smaller biotech companies in today’s capital environment?
Smaller biotech firms often experience more fluid and rapidly changing dynamics compared to larger pharmaceutical companies, with their needs frequently shifting due to changes in the capital environment. Procos emphasizes flexibility and adaptability, adjusting timelines and being ready to scale production quickly as projects progress. Supporting these companies while managing the uncertainties in funding and timelines is key to fostering long-term, successful partnerships. What are Procos’ objectives for the upcoming year?
Procos is poised for transformative growth in 2025, driven in part by the commissioning of our R11 facility. This new facility will significantly enhance our small-scale production capacity, enabling us to meet the growing demand for high-quality, specialized APIs in the US market. We will continue to invest in cutting-edge technology and talent development to ensure we stay at the forefront of the API manufacturing industry and support our clients’ evolving needs.