Long term stability of lyophilized plasmid DNA pDERMATT

被引:13
|
作者
van der Heijden, Iris [1 ]
Beijnen, Jos H. [1 ]
Nuijen, Bastiaan [1 ]
机构
[1] Slotervaart Hosp, Netherlands Canc Inst, Dept Pharm & Pharmacol, NL-1066 EC Amsterdam, Netherlands
关键词
Plasmid DNA; Lyophilization; Stability; Topology; LIPID/DNA COMPLEXES; GENE DELIVERY; CLOSURES; MELANOMA; STORAGE;
D O I
10.1016/j.ijpharm.2013.06.010
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
In this short note we report on the shelf-life stability of pDERMATT (plasmid DNA encoding recombinant MART-1 and tetanus toxin fragment-c) 2 mg lyophilized powder for reconstitution for intradermal administration, used in an in-house, investigator-initiated clinical phase I study. pDERMATT was stored at 25 degrees C/60% relative humidity (6 months), 2-8 degrees C (24 months), and -20 degrees C (66 months) in the dark and analyzed at several timepoints during the conduct of the clinical study for appearance, identity, purity (plasmid topology), content and residual water content. pDERMATT appeared stable at all storage conditions for the periods tested which, although patient inclusion in the study was significantly delayed, ensured the clinical supply needs. This study shows that lyophilization is an useful tool to preserve the quality of the pDNA and can prevent the need for costly and time-consuming additional manufacture of drug product in case of study delays, not uncommon at the early stage of drug development. To our knowledge, this is the first study reporting shelf life stability of a pDNA formulation for more than 5 years. (C) 2013 Elsevier B.V. All rights reserved.
引用
收藏
页码:648 / 650
页数:3
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