#United States #Princeton, NJ #Cell Therapy #Made Scientific #GMP Facility

Made Scientific's Expansion: A Leap Forward in Cell Therapy Manufacturing

Made Scientific, a prominent player in the field of cell therapy contract development and manufacturing, has announced a significant expansion of its manufacturing facility located in Princeton, New Jersey. Covering an area of 12,000 square feet, this expansion aims to address the growing demand from late-phase and commercial clients, particularly as more therapies transition into the advanced stages of development. This multi-phase expansion is not just about increasing space; it’s about enhancing capabilities to support the expected surge in advanced therapy approvals.

According to Syed T. Husain, Chairman and CEO of Made Scientific, the need for commercial-ready infrastructure is more urgent than ever. "As therapies progress through late-stage development, the demand for a robust manufacturing framework that aligns with regulatory standards is increasing," Husain explained. This new facility is designed to fulfill that necessity, providing a scalable, globally compliant platform that will aid partners in delivering life-changing therapeutics to market with assurance.

The first phase of the Princeton facility expansion will add over 9,000 square feet of GMP (Good Manufacturing Practice) cleanroom space, executed in collaboration with Orchestra Life Sciences. This new cleanroom setup is tailored to comply with both U.S. FDA regulations and EU Annex 1 standards. Highly automated bioprocessing systems will be integrated, facilitating high-throughput manufacturing operations suitable for both autologous and allogeneic workflows at scale. A vital part of this expansion is a concentrated quality control (QC) initiative that aims to improve the laboratory infrastructure for swiftly processing QC batch releases, which is crucial for late-phase programs that require rapid turnaround times.

Phase 1 of this ambitious project is expected to kick off in the second quarter of 2025, with completion targeted for the third quarter of 2026. In the end, this expansion is projected to enable the manufacturing of up to 2,000 additional batches annually, drastically increasing production capabilities for both personalized therapies and those available off-the-shelf during pivotal and commercial phases.

Currently, Made Scientific's Princeton headquarters totals 60,000 square feet, incorporating process and analytical development labs and several ISO 7 / Grade B cleanrooms. These facilities already support clinical manufacturing, highlighting the company’s commitment to offering comprehensive services. The strategic investments in digital infrastructure—including platforms like Veeva Systems for Quality Management Systems, Autolomous AutoloMATE® for electronic batch records, and LabVantage® for laboratory information management—further enhance the operational efficiency and data integrity across various processes.

Made Scientific is also making strides in workforce development by integrating a unique training program within its GMP operations. This program is critical in equipping the next generation of biomanufacturing professionals with hands-on experience and practical knowledge tailored to the rapidly evolving field of cell therapy. The initiative includes both pilot labs for training and virtual learning opportunities, bridging theoretical knowledge with real-world applications.

In conclusion, with this expansion, Made Scientific is not just increasing its manufacturing capabilities; it’s making a powerful statement about the future of cell therapy manufacturing. Its combine focus on efficient scalability, quality assurance, and workforce through comprehensive training reflects a steadfast commitment to redefining industry limits for the benefit of innovators and patients worldwide. As Made Scientific continues to evolve with the landscape of advanced therapeutics, it remains dedicated to supporting the future of healthcare through exceptional manufacturing and service standards.

For more details about Made Scientific and its services, visit www.madescientific.com.