Andelyn Biosciences Collaborates with Grace Science to Enhance GS-100

Andelyn Biosciences and Grace Science Partner to Speed Up Manufacturing of GS-100 for NGLY1 Deficiency Treatment

In a partnership aimed at accelerating the development and manufacturing of GS-100, a suspension process AAV NGLY1 gene therapy for Phase I/II/III clinical trial material for the treatment of NGLY1 Deficiency, Andelyn Biosciences Inc. has teamed up with Grace Science LLC. This collaboration will utilize Andelyn’s expertise in AAV processes and capabilities in late-stage manufacturing and commercial readiness to speed up Grace Science’s manufacturing timelines.

Matt Wilsey, CEO and Co-Founder of Grace Science, expressed excitement about the partnership, stating that Andelyn’s expertise in AAV gene therapy manufacturing will ensure that NGLY1 patients have access to safe, high-quality drug products for their clinical trial and beyond. The partnership between Andelyn Biosciences and Grace Science aims to bring hope and relief to patients suffering from NGLY1 Deficiency through the development and manufacturing of GS-100.

In February of this year, Grace Science successfully dosed the first NGLY1 Deficiency patient with GS-100, which was granted orphan drug designation (ODD) by the FDA and EMA in 2021, along with Rare Pediatric Disease Designation by the FDA. Matt Niloff, Chief Commercial Officer at Andelyn Biosciences, emphasized the strong collaboration and customer-centric focus shared by both companies, providing confidence and hope for the success of the GS-100 program.

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