PNKP抑制剂A83B4C63 与Dalton Pharma一起生产,进入第一阶段试验。
Onco-Innovations advances PNKP inhibitor A83B4C63 production with Dalton Pharma, moving toward Phase 1 trials.
通过与Dalton Pharma Services合作,在林业发展局和加拿大卫生部核准的多伦多设施优化和扩大生产,On-co-Inventions已推进其PNKP A83B4C63抑制剂A83B4C6。
Onco-Innovations has advanced its PNKP inhibitor A83B4C63 by optimizing and scaling up production in collaboration with Dalton Pharma Services at a Toronto facility approved by the FDA and Health Canada.
这项工作的重点是改进合成方法,生产大约500克前体A83和1,000克B4,以及在非全球生产管理计划条件下的限定分析方法。
The work focuses on refining synthesis methods, producing approximately 500 grams of precursor A83 and 1,000 grams of B4, and qualifying analytical methods under non-GMP conditions.
目标是为今后的全球监测方案生产建立一个可扩展、可复制的进程,以支持即将到来的第一阶段临床试验。
The goal is to establish a scalable, reproducible process for future GMP manufacturing to support upcoming Phase 1 clinical trials.
该药物是密封纳米粒子小鼠配方的一部分,目的是改进肿瘤的定位。
The drug is part of an encapsulated nanoparticle micelle formulation designed to improve tumor targeting.
该里程碑标志着向临床准备迈出的关键一步,道尔顿的监管专长和制造能力发挥着关键作用。
The milestone marks a key step toward clinical readiness, with Dalton’s regulatory expertise and manufacturing capabilities playing a critical role.