Orchard Therapeutics Announces the Build-out of New Gene Therapy Manufacturing Facility in California

美国生物制药公司 Orchard 宣布将在加州新建工厂,以期扩大产能及寻求新合作

2018-12-14 08:11:18 Investing News Network


BOSTON and LONDON, Dec. 13, 2018 (GLOBE NEWSWIRE) -- Orchard Therapeutics (NASDAQ: ORTX), a leading commercial-stage biopharmaceutical company dedicated to transforming the lives of patients with serious and life-threatening rare diseases through innovative gene therapies, today announced that it has signed a long-term lease agreement to build-out a gene therapy manufacturing facility in Fremont, California. The new 150,000-square-foot facility significantly increases Orchard’s California footprint and adds to the Foster City and Menlo Park, California sites, which oversee the ongoing development and validation of the manufacture of Orchard’s ex vivo gene therapy product candidates. Once operational, the new site will provide significant additional CGMP manufacturing capacity for both lentiviral vector and cryopreserved cell therapy products, enhancing Orchard’s ability to manufacture and deliver gene-corrected hematopoetic stem cells for a wide range of diseases on a global basis. In addition to this expanded capacity, Orchard also plans to continue its close collaborations with the Company’s contract manufacturing partners. “The expansion of our California operations to now include a manufacturing facility is a critical step in advancing Orchard’s capabilities to supply products for our ex vivo gene therapy programs,” said Stewart Craig, Ph.D., chief manufacturing officer of Orchard. “We believe that this new facility, as an early investment in our own manufacturing, will not only drive efficiencies and scalability in terms of lentiviral vector and drug product development, it will also complement the capabilities of our existing vector and drug product manufacturing partners to support the potential launch of our gene therapy clinical product candidates.” The build-out of Orchard’s new manufacturing facility is expected to begin in 2019, and the Company expects to hire more than 100 full-time employees over the next few years to support in-house manufacturing efforts. “Orchard’s new California manufacturing facility will provide enhanced capacity and long-term supply in support of our extensive pipeline beyond the Company’s most advanced clinical programs,” said Mark Rothera, president and chief executive officer of Orchard. “We are pleased to continue our growth in the Bay Area and look forward to welcoming additional technical and management talent to join our mission of transforming patient’s lives through gene therapy.” About Orchard Orchard Therapeutics is a fully integrated commercial-stage biopharmaceutical company dedicated to transforming the lives of patients with serious and life-threatening rare diseases through innovative gene therapies. Orchard’s portfolio of autologous ex vivo gene therapies includes Strimvelis, the first autologous ex vivo gene therapy approved by the European Medicines Agency for adenosine deaminase severe combined immunodeficiency (ADA-SCID). Additional programs for primary immune deficiencies, neurometabolic disorders and hemoglobinopathies include three advanced registrational studies for ADA-SCID, metachromatic leukodystrophy (MLD) and Wiskott-Aldrich syndrome (WAS), clinical programs for X-linked chronic granulomatous disease (X-CGD) and transfusion dependent beta-thalassemia (TDBT), as well as an extensive preclinical pipeline.
波士顿和伦敦,2018年12月13日(GLOBE NEWSWIRE) - Orchard Therapeutics(纳斯达克股票代码:ORTX),一家领先的商业阶段生物制药公司,致力于通过创新的基因疗法改变患有严重和危及生命的罕见疾病患者的生活,今天宣布已签署长期租赁协议,在加利福尼亚州弗里蒙特建立基因治疗制造工厂。新的150,000平方英尺的工厂大大增加了Orchard在加利福尼亚州的占地面积,并增加了位于加利福尼亚州福斯特城和门洛帕克的工厂,这些工厂负责监督Orchard 离体基因治疗产品候选产品的持续开发和验证。 一旦投入使用,新网站将为慢病毒载体和冷冻保存的细胞治疗产品提供显着的额外CGMP制造能力,从而增强Orchard在全球范围内为多种疾病制造和提供基因校正的造血干细胞的能力。除了扩大产能外,Orchard还计划继续与公司的合同制造合作伙伴密切合作。 “我们加利福尼亚州的业务扩展到现在包括一个制造工厂,这是推动Orchard为我们的离体基因治疗项目提供产品的能力的关键一步,”Orchard首席制造官Stewart Craig博士说。“我们相信这个新设施作为我们自己制造业的早期投资,不仅可以提高慢病毒载体和药物产品开发的效率和可扩展性,还可以补充我们现有的载体和药品生产合作伙伴的能力。支持我们的基因疗法临床产品候选人的潜在发起。“ Orchard新生产设施的建设预计将于2019年开始,公司预计在未来几年内将雇用100多名全职员工,以支持内部制造工作。 “Orchard的新加州制造工厂将提供增强的产能和长期供应,以支持我们在公司最先进的临床计划之外的广泛管道,”Orchard总裁兼首席执行官Mark Rothera说。“我们很高兴继续在湾区的发展,并期待着欢迎更多的技术和管理人才加入我们通过基因疗法改变患者生活的使命。” 关于Orchard Orchard Therapeutics是一家完全整合的商业阶段生物制药公司,致力于通过创新的基因疗法改变患有严重和危及生命的罕见疾病患者的生活。 Orchard的自体离体基因治疗组合包括Strimvelis,这是欧洲药品管理局批准的第一种自体离体基因治疗,用于腺苷脱氨酶严重联合免疫缺陷(ADA-SCID)。原发性免疫缺陷,神经代谢紊乱和血红蛋白病的其他计划包括ADA-SCID,异染性脑白质营养不良(MLD)和Wiskott-Aldrich综合征(WAS)的三项高级登记研究,X-连锁慢性肉芽肿病(X-CGD)的临床计划和输血依赖性β-地中海贫血(TDBT),以及广泛的临床前管道。