Made Scientific announced a significant expansion of its Princeton, New Jersey facility to meet increasing demand from late-phase and commercial clients and support the anticipated rise in approved advanced therapies.
"As more therapies advance to late-stage development, the demand for commercial-ready infrastructure is accelerating," said Syed T. Husain, Chairman and CEO of Made Scientific. "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."
The 12,000 sq. ft. expansion will add over 9,000 sq. ft. of GMP manufacturing cleanroom space across two phases. 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. The new space will be designed to meet U.S. FDA and EU Annex 1 compliance and will incorporate high-throughput ballroom manufacturing and next-generation automated bioprocessing systems to support both autologous and allogeneic workflows at scale. Additionally, included is 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.
Phase 1 of the commercial expansion is set to initiate in Q2 2025, and will be completed by Q3 2026, with 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.
This expansion will optimize Made Scientific's 60,000 sq. ft. Princeton headquarters, which currently includes process and analytical development laboratories, six (6) independent ISO 7 / Grade B cleanrooms with scalable production platforms to support clinical manufacturing, and inhouse quality control testing. To support seamless scale-up, Made Scientific has also 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.
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—bridging academic knowledge with real-world application to equip the next generation of biomanufacturing talent.