Made Scientific Acquires 85,000 sq. ft. Cell Therapy GMP Facility in Pennsylvania
- Made Scientific acquired an operational 85,000 sq. ft. cell therapy manufacturing facility in East Norriton, Pennsylvania from National Resilience, with 145 prior GMP batches executed across CAR-T and allogeneic programs.
- The site includes eight Grade B/C cleanrooms, one Grade C ballroom, one Grade B fill-finish suite, and 30,000 sq. ft. of expansion space designed for eight additional ballrooms.
- Made Scientific's total U.S. East Coast footprint now spans 145,000 sq. ft. with 15 qualified GMP suites; the company expects FDA pre-licensure inspections at both locations in early 2027.
Operational Impact
Made Scientific's acquisition of the operational East Norriton facility with 145 executed GMP batches and 30,000 sq. ft. of expansion capacity adds immediate cell therapy manufacturing availability for sponsors seeking 2027 clinical and commercial supply, while the company prepares both locations for FDA pre-licensure inspections in early 2027.
Source: Contract Pharma Breaking News RSS
Andelyn Biosciences Launches Commercial Manufacturing of FDA-Approved Gene Therapy Fayuvi
- Andelyn Biosciences has begun commercial manufacturing of Fayuvi (rebisufligene etisparvovec-hopf) at its Columbus, Ohio facility following FDA approval for Sanfilippo syndrome type A treatment.
- Fayuvi is the first FDA-approved gene therapy manufactured using Andelyn's proprietary AAV Curator® Platform process, which integrates modular manufacturing strategies and fit-for-purpose analytics.
Operational Impact
Andelyn's Columbus facility now demonstrates validated commercial GMP capacity for AAV gene therapies, establishing proof-of-concept for its proprietary platform and positioning the CDMO for additional gene therapy partnerships.
Source: PharmaSource RSS