Made Scientific, a contract development and manufacturing organisation (CDMO) specialising in cell therapies, has expanded its Princeton facility to accommodate increasing demand from late-phase and commercial clients.
The new facility in New Jersey, US, comes as the market for approved advanced therapies continues to grow, placing new pressures on manufacturing infrastructure.
The company will add a further 12,000 sqft to its existing site, including more than 9,000 sqft of GMP manufacturing cleanroom space, delivered across two phases.
The expansion has been designed in collaboration with specialist engineering firm Orchestra Life Sciences and will adhere to global regulatory requirements, including US FDA and EU Annex 1 standards.
The company will add a further 12,000 sqft to its existing site
“As more therapies advance to late-stage development, the demand for commercial-ready infrastructure is accelerating,” commented Syed Husain, Chairman and CEO of Made Scientific. “Our Princeton expansion delivers exactly that — a purpose-built, globally compliant platform designed to scale programmes efficiently, meet regulatory expectations, and help our partners bring life-changing therapies to market with confidence.”
Facility design
The upgraded facility will incorporate high-throughput ballroom manufacturing suites and next-generation automated bioprocessing systems, supporting both autologous and allogeneic workflows.
The site will also feature an enhanced quality control (QC) laboratory infrastructure, optimised for high-throughput and rapid batch release to meet the demands of fast-paced late-phase programmes.
Construction of Phase 1 is set to begin in Q2 2025, with completion expected by Q3 2026. Phase 2 will follow thereafter. Once operational, the expanded facility will enable an additional throughput of up to 2,000 manufacturing batches per year, significantly boosting capacity for both personalised and off-the-shelf cell therapies at pivotal and commercial stages.
The upgraded facility will incorporate high-throughput ballroom manufacturing suites
This latest expansion will optimise Made Scientific’s 60,000 sqft Princeton headquarters, which already houses process and analytical development laboratories, six ISO Class 7 / Grade B cleanrooms for clinical manufacturing, and in-house quality control testing.
The company has also invested in an integrated suite of digital business systems, including Veeva Systems for quality management, Autolomous AutoloMATE (registered trademark) for electronic batch records, Oracle NetSuite (registered trademark) for enterprise resource planning, and LabVantage (registered trademark) as its laboratory information management system.
These platforms collectively enhance data integrity, batch traceability, and operational oversight.
Founded in the United States, Made Scientific’s Princeton site serves as the company’s flagship facility for integrated development and manufacturing services, encompassing technology transfer, process development, GMP drug substance and product manufacturing, aseptic fill-finish, QC testing, and regulatory support.
This latest expansion will optimise Made Scientific’s 60,000 sq. ft. Princeton headquarters, which already houses process and analytical development laboratories
Together with its Newark, New Jersey facilities, which specialise in early-phase and hybrid-hotel manufacturing, the company provides a full continuum of services for cell therapy developers working across T-cell, NK cell, HSC, MSC, iPSC, and TIL-based programmes.
Training initiatives
The organisation also operates a dedicated workforce development and training initiative, integrated within its GMP operations.
This modular platform offers both hands-on and virtual training programmes in cell therapy development, biomanufacturing, and advanced analytics, helping to build the next generation of biomanufacturing talent.
With expanded GMP capacity, a flexible operational model, and an emphasis on operational excellence, Made Scientific continues to advance its mission to redefine cell therapy manufacturing and deliver robust solutions for advanced therapy innovators and their patients globally.