Abeona Therapeutics Inc., a clinical-stage biopharmaceutical company, announced the opening of The Elisa Linton Center for Rare Disease Therapies, a commercial GMP manufacturing facility for gene and cell therapies in Cleveland, OH. The company broke ground on the 6,000-square-foot facility on October 4, 2017.
The GMP facility will have the capability to manufacture Abeona’s clinical and commercial grade products, including programs aimed at recessive dystrophic epidermolysis bullosa (RDEB) and Sanfilippo syndrome type A (MPS IIIA).
Both programs were recently granted the Regenerative Medicine Advanced Therapy designation by the U.S. Food and Drug Administration, emphasizing the unmet need for patients suffering from those conditions.
Ribbon cutting ceremony at The Elisa Linton Center for Rare Disease Therapies in Cleveland on May 31, 2018. (Credit: Abeona Therapeutics Inc.)
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 the treatment of RDEB, a rare and devastating skin disorder. ABO-102 is an adeno-associated virus (AAV)-based gene therapy in development at Abeona for the treatment of MPS IIIA.
In addition to the production of the EB-101 and ABO-102 therapies, the 6,000-square-foot facility is expected to satisfy chemistry, manufacturing, and controls requirements for commercial development, according to the company.
In a follow-up strategic manufacturing stage, Abeona told investors in April that the company has initiated construction of an additional 20,000-square-foot facility that will be used to meet anticipated commercial demand for development programs in the longer term. The new facility will be on the same site as the Elisa Linton Center at 6555 Carnegie Avenue, Cleveland.
Abeona Therapeutics develops cell and gene therapies for life-threatening rare genetic diseases.
(Source: Abeona Therapeutics Inc.)
