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CytoImmune Therapeutics Positioned to Accelerate U.S. Pharma Reshoring Efforts Amid Executive Order to Boost Domestic Drug Manufacturing


News provided by

CytoImmune Therapeutics

May 07, 2025, 09:05 ET

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CytoImmune Therapeutics
CytoImmune Therapeutics

CytoImmune's initial 200% expansion of its commercial monoclonal antibody (mAb) manufacturing capacity will be ready for product transfer and regulatory inspections by 2027, with a second phase planned for 2028. Once complete, the facility is expected to produce 2.6 metric tons of therapeutic proteins per year, along with injectable drug products.

SAN JUAN, Puerto Rico, May 7, 2025 /PRNewswire-PRWeb/ -- CytoImmune Therapeutics, a pioneering biopharmaceutical company specializing in immunotherapy and monoclonal antibody (mAb) manufacturing, announced today its readiness to support pharmaceutical companies looking to rapidly expand domestic production capacity in response to President Donald Trump's recent executive order aimed at reshoring pharmaceutical manufacturing.

The executive order, signed by President Trump on May 5, 2025, underscores the strategic imperative of reducing dependency on overseas pharmaceutical production, streamlining FDA approvals for domestic manufacturing, and enhancing national security through increased domestic pharmaceutical production.

Our facility's advanced analytics and automated bioprocessing technologies optimize productivity and profitability.

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"CytoImmune is uniquely prepared to help U.S. pharmaceutical companies meet these ambitious goals," said Jose Vidal, CEO of CytoImmune Therapeutics. "With our state-of-the-art 40,000 sq ft biopharma complex located in Puerto Rico, substantial Act 60 incentives, and advanced bioprocessing technologies, we provide an unparalleled advantage for companies reshoring manufacturing and development operations."

Puerto Rico offers a highly skilled biotech workforce, a robust pharmaceutical manufacturing infrastructure, and significant tax incentives under Act 60, including reduced corporate tax rates and tax exemptions for eligible R&D and export services—making it an ideal location for biopharmaceutical production. The company's facility in Puerto Rico offers an ideal environment for rapid scale-up, boasting cutting-edge, AI-driven bioprocessing capabilities and modular design suited for immediate deployment. CytoImmune's platform significantly reduces time-to-market for biologics, with advanced capabilities designed to scale from pilot production to commercial supply seamlessly.

"Our facility's advanced analytics and automated bioprocessing technologies optimize productivity and profitability," Vidal added. "Strategic partners benefit from superior returns on capital investment, accelerated development timelines, and robust intellectual property opportunities."

CytoImmune anticipates substantial growth in the mAb market, projected to reach $635 billion globally by 2034. Recognizing the critical need to increase U.S. pharmaceutical manufacturing capacity by approximately 275% within the next decade, CytoImmune is positioned to play a pivotal role in reshoring vital biomanufacturing operations.

CytoImmune’s initial 200% expansion of its commercial monoclonal antibody (mAb) manufacturing capacity will be ready for product transfer and regulatory inspections by 2027, with a second phase planned for 2028. Once complete, the facility is expected to produce 2.6 metric tons of therapeutic proteins per year, along with injectable drug products.

CytoImmune invites pharmaceutical companies and strategic partners to explore collaborative opportunities, leveraging its innovative platform, favorable economic incentives, and commitment to accelerating the production of life-changing therapies in the United States.

For further information on strategic partnerships and collaboration opportunities with CytoImmune Therapeutics, visit www.cytoimmune.com.

Contact:

Investor Relations

CytoImmune Therapeutics

Email: [email protected]

Phone: (787) 555-0199

Media Contact

Albert Stichka, Elkordy Global, 1 6192544768, [email protected]

SOURCE CytoImmune Therapeutics

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