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新会员聚光灯:pluristyx

“beplay华为下载再生药物产品具有相当大的治疗潜力,可治疗各种严重疾病和伤害,但目前尚未被认为是可行的前线疗法,主要是由于制造复杂性,产品变异性和高成本的组合,”解释说Brian Hawkins,首席技术官,加入,“因此,这些产品通常被降到稀有或孤儿疾病,其中替代疗法不可用。”

再生药物作为一种可行的前线治疗作为一般人群(如心脏病或beplay华为下载糖尿病)的可行的前线治疗,需要克服这些挑战并以合理的成本制造大量细胞。这些细胞还需要在良好的制造实践(GMP)下可重复制造,并根据监管机构要求进行预先确定的规格。

Pluristyx成立于2018年,目的是通过大规模制造GMP级多能干细胞来解决这些挑战,以用作普遍原料,用于进一步制造治疗再生药品。beplay华为下载Pluristyx还提供合同开发和制造服务以及化学,制造和控制(CMC)咨询药物开发,再生医学和细胞和基因改性细胞疗法领域的公司。beplay华为下载

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“在Ploristyx,我们认为,可以以适当的规模和成本制造从多能干细胞的同种异体beplay华为下载再生医学治疗,并使能够与竞争或甚至优于俯视电流疗法的可行性现货产品制造。我们认为,基于细胞的疗法不仅具有管理疾病症状的能力,而且有效地治愈了慢性,年龄相关和衰弱疾病的患者,“霍金斯博士继续。

Pluristyx first engaged with ARMI|BioFabUSA prior to the organization’s formal incorporation in early 2018. The company’s co-founder, Dr. Ben Fryer, formerly Head of Stem Cell Manufacturing at the University of Washington, lead the push to commercialize pluripotent stem cells for clinical use. Dr. Fryer identified early on the need for platform technologies that can drive down costs and reduce the variability inherent in current cell manufacturing methods, and joined ARMI at that time to leverage the combined knowledge of its members to aid his efforts. Dr. Fryer transferred his enthusiasm and talents to ARMI as soon as Pluristyx was founded, and the Pluristyx team has since become highly involved in advancing the ARMI mission for the ‘practical large-scale manufacturing of engineered tissue and tissue-related technologies.’

“随着潜力分化为所有细胞类型,多能细胞是用于再生医学应用的理想原料,”霍金斯表示,添加“,”随着适当的控制和制造实践,可以将多能细胞开发成可以服务的母细胞库beplay华为下载作为整个终身临床产品的基本构建块。“

使用小规模生产模型制造的细胞是劳动密集型的,并且根据PluriStyx患有固有的和不可接受的产品变异性,因此该公司开发了一个平台技术,该技术包括过程监测和控制,以最大限度地减少传统的可比性问题和过程变化。细胞疗法制造模型。“最终的多能干细胞产物完全表征,记录为GMP要求,并在过程中跟踪,以产生大量释放,可以立即以2D或3D格式分化为任何组织类型,而无需进一步扩展,”霍金斯解释。

Plinistyx Ready-to-Commoediate™(RTD™-PSC)产品将实现更一致的过程和产品开发工作流程,可以在整个临床前/临床开发连续体中进行缩放。Plinistyx制造设计提供的大量释放允许开发需要大量细胞的应用,包括但不限于有机体和3D生物印刷。

“We know that the mission of ARMI is to make practical the large-scale manufacturing of engineered tissue and tissue-related technologies and, from our perspective, the key words in that mission are ‘practical’ and ‘large-scale’ as approved cell therapies to date are autologous products that are manufactured as individual batches for a single patient. While highly successful in selected patient populations, the autologous manufacturing model is neither scalable nor cost-effective for large cohorts. In order to truly bring regenerative medicine to the masses, practical and scalable manufacturing technologies are needed to standardize product development and commercialization,” Dr. Hawkins concluded.

plinistyx希望为ARMI成员提供CMC知识支持和合同开发服务,以弥合临床前/概念研究和商业化临床产品之间的差距。该公司旨在提供全面的,记录的和准备鉴别的多能干细胞的ARMI成员,可用作下游产品开发的通用原料。