Abeona Opens Commercial Gene & Cell Therapy Mfg Facility
Abeona Therapeutics, a Dallas, Texas-headquartered clinical-stage biopharmaceutical company, has opened a commercial GMP manufacturing facility for gene and cell therapies in Cleveland, Ohio called The Elisa Linton Center for Rare Disease Therapies.
The GMP facility is designed to manufacture clinical and commercial-grade products over Abeona’s multiple clinical programs, including therapies to treat recessive dystrophic epidermolysis bullosa (RDEB), a rare skin disorder, and Sanfilippo Syndrome, a rare autosomal recessive lysosomal storage disease.
EB-101 is an autologous, ex-vivo gene-corrected cell therapy where the COL7A1 gene is inserted into a patient’s own skin cells (keratinocytes) for treating RDEB. ABO-102 is an adeno-associated virus (AAV)-based gene therapy for treating Sanfilippo Syndrome Type A. Both programs were recently granted regenerative medicine advanced therapy designation by the US Food and Drug Administration.
In addition to producing EB-101 and ABO-102and the AIM AAV vector lab, Abeona says that the 6,000-square-foot facility will satisfy the necessary chemistry, manufacturing and controls (CMC) requirements for commercial development. The second stage of the company’s manufacturing strategy has been initiated with the construction of an additional 20,000-square-foot facility to further meet the anticipated commercial demand for development programs in the longer term.
Source: Abeona Therapeutics