In response to President Donald Trump’s executive order promoting domestic pharmaceutical manufacturing, CytoImmune Therapeutics is doubling down on its investment in US-based biomanufacturing.

In this exclusive interview, president Will Rosellini outlines how the company’s advanced Puerto Rican facility supports national reshoring goals, accelerates monoclonal antibody production, and strengthens pharmaceutical supply chain resilience.

Policy and industry impact

What is your reaction to President Trump’s executive order on domestic pharmaceutical manufacturing?

We strongly support President Trump’s executive order aimed at reshoring pharmaceutical manufacturing. This measure underscores the necessity of reducing reliance on overseas production, streamlining FDA approvals, and bolstering national security. The executive order aligns closely with CytoImmune’s strategy of increasing domestic pharmaceutical capabilities.

What immediate impacts do you expect this policy to have on US-based pharmaceutical companies, especially those operating in Puerto Rico?

The policy will immediately incentivize U.S. pharmaceutical companies to accelerate domestic manufacturing expansions. For Puerto Rico-based companies like CytoImmune, this policy enhances the attractiveness of our location, leveraging significant tax incentives under Act 60 and a highly skilled biotech workforce to further solidify Puerto Rico as a biopharmaceutical hub.

How will potential tariffs on imported medicines affect the broader biopharmaceutical supply chain?

Potential tariffs may initially introduce cost pressures on the biopharmaceutical industry, but they also represent a powerful incentive for reshoring manufacturing operations. In the medium to long term, tariffs can drive greater investment in domestic facilities, bolstering resilience and creating a more self-reliant pharmaceutical supply chain.

CytoImmune’s role

How is CytoImmune Therapeutics prepared to support the push for reshoring manufacturing?

CytoImmune is ideally positioned to support reshoring efforts. Our 40,000 sq ft biopharma complex in Puerto Rico, equipped with advanced analytics, AI-driven bioprocessing, and automated manufacturing systems, ensures rapid scalability and optimized productivity. With our initial 200 percent expansion of monoclonal antibody manufacturing ready by 2027 and a subsequent phase planned for 2028, we’re uniquely prepared to address the domestic manufacturing surge.

Can you describe the capabilities of your new biopharma complex and how it fits into this national strategy?

Our facility is designed with modular scalability, capable of producing 2.6 metric tons of therapeutic proteins annually, including injectable drug products. The complex’s advanced bioprocessing and analytics systems significantly accelerate biologics’ time-to-market, seamlessly transitioning from pilot to commercial-scale production. This aligns precisely with national goals for domestic pharmaceutical capacity expansion.

How do your advanced analytics and automated bioprocessing technologies provide an edge in scaling domestic production?

Our advanced analytics and automated bioprocessing technologies drive productivity and profitability by reducing time-to-market and enhancing operational efficiency. These capabilities offer strategic partners accelerated development timelines, superior returns on capital investment, and robust intellectual property opportunities, which are critical for successful domestic production.

Puerto Rico’s position

Why do you believe Puerto Rico is uniquely positioned to become a hub for biomanufacturing in the US?

Puerto Rico’s highly skilled biotech workforce, robust pharmaceutical manufacturing infrastructure, and substantial Act 60 incentives—including reduced corporate taxes and exemptions for eligible R&D—make it an optimal location for reshoring and rapidly scaling biomanufacturing operations.

What infrastructure and workforce advantages does the island offer that other locations may not?

Puerto Rico offers FDA-approved infrastructure, advanced manufacturing facilities, and a highly experienced pharmaceutical workforce. The island’s unique combination of human capital, economic incentives under Act 60, and proven biopharma ecosystem is unmatched by other U.S. locations.

Are there regulatory or logistical challenges specific to Puerto Rico that need to be addressed to fully realize this potential?

While the advantages are substantial, further investment in infrastructure modernization and continued efforts to streamline regulatory harmonization with the mainland U.S. are necessary to fully unlock Puerto Rico’s biomanufacturing potential.

Strategic vision

CytoImmune has recently made acquisitions and infrastructure investments. How do these align with your long-term vision for reshoring manufacturing?

Our recent infrastructure investments and the phased expansion of our manufacturing capacity align perfectly with our vision of becoming a cornerstone of US pharmaceutical reshoring efforts. These investments position CytoImmune to lead the substantial growth projected in the monoclonal antibody market, anticipated to reach $635 billion globally by 2034.

Do you foresee partnerships with larger pharmaceutical companies to help them meet domestic manufacturing goals?

Absolutely. We are actively seeking strategic partnerships to leverage our advanced bioprocessing platform and favorable economic incentives, enabling larger pharmaceutical companies to rapidly scale their domestic manufacturing capabilities and achieve strategic national objectives.

What lessons were learned during the COVID-19 pandemic that inform your approach to reshoring and supply chain resilience?

COVID-19 highlighted the vulnerability of global supply chains, emphasizing the critical need for domestic manufacturing capabilities. CytoImmune’s investments and infrastructure strategy reflect these lessons, prioritizing agile, scalable production that can swiftly respond to emerging health crises.

Broader Implications

Do you think the executive order goes far enough? What additional steps would you recommend the government take?

The executive order represents significant progress, but additional steps, such as further incentives for domestic manufacturing investments, additional funding for workforce training, and continued regulatory streamlining, will be essential to sustainably grow US pharmaceutical capacity.

How does this policy shift affect global pharmaceutical partnerships or dependencies?

This shift prompts a strategic reassessment of global pharmaceutical partnerships, balancing international collaboration with enhanced domestic resilience. While global partnerships will remain crucial, increasing domestic production reduces vulnerability to external supply chain disruptions.

What timeline do you expect for meaningful change in domestic manufacturing capacity as a result of this order?

Meaningful changes in domestic pharmaceutical manufacturing capacity can realistically occur within the next 3 to 5 years. CytoImmune’s own expansion timeline—initial production readiness by 2027 and further expansion by 2028—reflects the broader industry’s expected trajectory for increased domestic capabilities.