Lyophilization stabilizes clinical-stage core-crosslinked polymeric micelles to overcome cold chain supply challenges,Biotechnology Journal

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Lyophilization stabilizes clinical-stage core-crosslinked polymeric micelles to overcome cold chain supply challenges
Biotechnology Journal ( IF 3.2 ) Pub Date : 2021-01-23 , DOI: 10.1002/biot.202000212
Tarun Ojha _{1,

2,

3} , Qizhi Hu ₄ , Claudio Colombo ₄ , Jan Wit ₅ , Michiel van Geijn ₄ , Mies J van Steenbergen ₂ , Mahsa Bagheri ₂ , Hiltrud Königs-Werner ₆ , Eva Miriam Buhl ₆ , Ruchi Bansal _{1,

3} , Yang Shi ₁ , Wim E Hennink ₂ , Gert Storm _{2,

7} , Cristianne J F Rijcken ₄ , Twan Lammers _{1,

2,

7}

Affiliation

CriPec technology enables the generation of drug-entrapped biodegradable core-crosslinked polymeric micelles (CCPM) with high drug loading capacity, tailorable size, and drug release kinetics. Docetaxel (DTX)-entrapped CCPM, also referred to as CPC634, have demonstrated favorable pharmacokinetics, tolerability, and enhanced tumor uptake in patients. Clinical efficacy evaluation is ongoing. CPC634 is currently stored (shelf life > 5 years) and shipped as a frozen aqueous dispersion at temperatures below −60°C, in order to prevent premature release of DTX and hydrolysis of the core-crosslinks. Consequently, like other aqueous nanomedicine formulations, CPC634 relies on cold chain supply, which is unfavorable for commercialization. Lyophilization can help to bypass this issue.

中文翻译：

冻干稳定临床阶段的核心交联聚合物胶束以克服冷链供应挑战

CriPec 技术能够生成具有高载药量、可定制尺寸和药物释放动力学的药物包埋的可生物降解核心交联聚合物胶束 (CCPM)。多西紫杉醇 (DTX) 包裹的 CCPM，也称为 CPC634，已显示出良好的药代动力学、耐受性和增强的患者肿瘤摄取。临床疗效评估正在进行中。CPC634 目前储存（保质期 > 5 年）并在低于 -60°C 的温度下作为冷冻水分散体运输，以防止 DTX 过早释放和核心交联的水解。因此，与其他水性纳米药物制剂一样，CPC634依赖冷链供应，不利于商业化。冻干可以帮助绕过这个问题。

更新日期：2021-01-23

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