Friday, June 10, 2022 Daily Archives

FDA AdCom endorses bluebird’s CALD gene therapy

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An FDA Advisory Committee has unanimously agreed bluebird bio’s gene therapy elivaldogene autotemcel (eli-cel) outweigh the risks in treating early active cerebral adrenoleukodystrophy (CALD). The US Food and Drug Administration’s (FDA) Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) met yesterday to evaluate bluebird bio’s eli-cel as a treatment of early active cerebral adrenoleukodystrophy (CALD) in patients less than 18 years of age who do not have an available and willing human leukocyte antigen (HLA)-matched sibling hematopoietic stem cell (HSC)…

June 10, 2022

WuXi Bio opens fill-finish facility in China

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WuXi Biologics has launched the operation of its drug product facility in Wuxi, China increasing pre-filled syringes (PFS) capacity to 17 million units annually. Contract development manufacturing organization (CDMO) WuXi Bio’s latest DP facility, named DP5, includes an advanced isolator filling line used for steady and continuous filling services. The firm says that this offers different volume delivery options for PFS, such as 1 mL Long, 1 mL, 2.25 mL, and 3 mL. “The design of operation area, material flow,…

June 10, 2022

Coave and ABL partner to develop gene therapy manufacturing processes

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The two-stage collaboration will aim to drive development of high-capacity production processes for AAV-based products. Coave Therapeutics, a biotechnology firm focused on developing gene therapies for central nervous system (CNS) and eye diseases, aims to secure its process development capabilities and infrastructure needs through collaboration with contract development manufacturing organization (CDMO) ABL, which specializes in the manufacturing of viruses for vaccine candidates and gene and cancer therapies. “Coave has already developed a process at laboratory scale and has several patents.…

June 10, 2022