Monday, May 9, 2022 Daily Archives

Regenxbio: ‘CDMO issue validates inhouse gene therapy investment’

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Regenxbio will begin inhouse production of material for its Duchenne Muscular Dystrophy (DMD) gene therapy after a quality issue at a third-party manufacturer delayed clinical trial dosing. The initiation of dosing adeno-associated viral (AAV) based gene therapy candidate RGX-202 for a Phase I/II clinical trial has been delayed by between six and 12 months, Regenxbio announced last week during its first quarter 2022 financial results. According to CEO Ken Mills, the delay is due to an issue at an undisclosed contract…

May 9, 2022

CureDuchenne talks solutions to fill gaps in the CGT space

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BioProcess Insider spoke with Michael Kelly, CureDuchenne’s chief scientific officer, to discuss gaps in the gene therapy space and the strategy the firm is adopting to try and fill them. Before joining CureDuchenne, Kelly served in various roles. This includes his position as president and US site head of Renovis, as well as holding senior positions at Amgen, Wyeth (Pfizer), and Wellcome (GlaxoSmithKline). BioProcess Insider (BI): What are the gaps in the gene therapy space? Mike Kelly (MK): Some of…

May 9, 2022

Matica Bio opens CGT plant, with a little help from G-CON and Sartorius

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The CDMO’s facility in College Station, TX consists of modular cleanrooms provided by G-CON and technologies supplied by Sartorius. Contract development and manufacturing organization (CDMO) Matica Biotechnology opened the 45,000 square-foot facility this week to provide viral vectors and cell-based products to cell and gene therapy (CGT) developers. The facility is fully financed by Matica’s parent company – though the size of the investment as not been revealed – and built out from an existing shell using modular cleanrooms from…

May 9, 2022