Made Scientific, a leading cell therapy contract development and manufacturing organization (CDMO), announced a significant expansion of its Princeton, New Jersey facility to address the accelerating demand for commercial-ready cell therapy manufacturing infrastructure. The 12,000 sq. ft. expansion will add over 9,000 sq. ft. of GMP manufacturing cleanroom space across two phases, with completion targeted for Q3 2026.
Strategic Partnership for Advanced Manufacturing Design
In collaboration with design and engineering partner Orchestra Life Sciences, Made Scientific is finalizing the build-out concept to align with global regulatory and operational best practices. Orchestra was selected for its track record in advanced therapy facility design and experience implementing automation and developing integrated quality management systems across multiple continents.
"Their expertise in facility design, engineering solutions, and operational excellence aligns perfectly with our vision for creating a cutting-edge manufacturing center that will serve the evolving clinical- and commercial-stage needs of our clients," said Syed T. Husain, Chairman and CEO of Made Scientific.
Regulatory Compliance and Manufacturing Capabilities
The new space will be designed to meet U.S. FDA and EU Annex 1 compliance standards and will incorporate high-throughput ballroom manufacturing and next-generation automated bioprocessing systems to support both autologous and allogeneic workflows at scale. The expansion includes a focused quality control (QC) initiative, enhancing the site's lab infrastructure and equipment to enable high-throughput and rapid QC batch release in support of fast-moving late-phase programs.
"As more therapies advance to late-stage development, the demand for commercial-ready infrastructure is accelerating," said Husain. "Our Princeton expansion delivers exactly that—a purpose-built, globally compliant platform designed to scale programs efficiently, meet regulatory expectations, and help our partners bring life-changing therapies to market with confidence."
Enhanced Manufacturing Capacity and Timeline
Phase 1 of the commercial expansion is set to initiate in Q2 2025, with completion by Q3 2026, and Phase 2 planned thereafter. Once complete, the site will enable throughput of up to 2,000 additional manufacturing batches per year, significantly increasing capacity to support personalized and off-the-shelf therapies through pivotal and commercial stages.
The expansion will optimize Made Scientific's 60,000 sq. ft. Princeton headquarters, which currently includes process and analytical development laboratories, six independent ISO 7 / Grade B cleanrooms with scalable production platforms to support clinical manufacturing, and in-house quality control testing.
Digital Infrastructure and Technology Integration
To support seamless scale-up, Made Scientific has made significant investments in its digital business systems, including implementation of Veeva Systems for quality management (QMS), Autolomous AutoloMATE® for electronic batch records and manufacturing execution (MES), Oracle NetSuite® for enterprise resource planning (ERP), and LabVantage® as its laboratory information management system (LIMS). These platforms enhance data integrity, batch traceability, and end-to-end program oversight across Made's operations.
Comprehensive Service Portfolio
The Princeton facility serves as Made Scientific's flagship site for integrated development and manufacturing services, offering technology transfer, process development, GMP drug substance and product manufacturing, aseptic fill and finish, quality control testing, and regulatory support. Together with its Newark, NJ facilities, which focus on early-phase and hybrid-hotel manufacturing, Made Scientific delivers a full continuum of services designed to meet the evolving needs of cell therapy developers progressing T, NK, HSCs, MSCs, iPSC, TIL-based therapies and more.
Made Scientific also operates a focused workforce development and training program, a unique modular platform integrated within its GMP operations, and supported by additional pilot lab & classroom training facilities, offering hands-on and virtual learning programs for cell therapy development, biomanufacturing, and advanced analytics.
