Made Scientific opens GMP cell therapy facility in New Jersey

Made Scientific, a U.S.-based cell therapy contract development and manufacturing organization (CDMO) headquartered in Princeton, New Jersey, has opened its new 60,000-square-foot GMP manufacturing facility and headquarters. 

According to the company, the facility includes five ISO 7/Grade B cleanrooms, in-house quality control labs, and dedicated process and analytical development capabilities. The site also incorporates Oracle NetSuite for enterprise resource planning, Veeva Systems for quality management, Autolomous AutoloMATE for electronic batch records and manufacturing execution, and LabVantage for laboratory information management.

The $12 million investment in facility upgrades, equipment, and business system digitization is intended to strengthen the company’s cell therapy manufacturing capacity. The facility is designed to support both autologous and allogeneic programs from clinical through commercial scale, the company said.

Made Scientific also noted that a second phase of expansion has been announced, adding 12,000 square feet of GMP manufacturing cleanroom space. Once complete, the expansion is expected to increase capacity by up to 2,000 additional batches per year and meet U.S. FDA and EU Annex 1 compliance standards.