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.
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Univ Colorado, Dept Mol Cellular & Dev Biol, Boulder, CO 80309 USAUniv Colorado, Dept Mol Cellular & Dev Biol, Boulder, CO 80309 USA
Hughes, Travis S.
Langer, Stephen J.
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Univ Colorado, Dept Mol Cellular & Dev Biol, Boulder, CO 80309 USAUniv Colorado, Dept Mol Cellular & Dev Biol, Boulder, CO 80309 USA
Langer, Stephen J.
Johnson, Kirk W.
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Avigen, Alameda, CA USAUniv Colorado, Dept Mol Cellular & Dev Biol, Boulder, CO 80309 USA
Johnson, Kirk W.
Chavez, Raymond A.
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Avigen, Alameda, CA USAUniv Colorado, Dept Mol Cellular & Dev Biol, Boulder, CO 80309 USA
Chavez, Raymond A.
Watkins, Linda R.
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Univ Colorado, Dept Psychol, Boulder, CO 80309 USA
Univ Colorado, Ctr Neurosci, Boulder, CO 80309 USAUniv Colorado, Dept Mol Cellular & Dev Biol, Boulder, CO 80309 USA
Watkins, Linda R.
Milligan, Erin D.
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Univ New Mexico, Hlth Sci Ctr, Dept Neurosci, Albuquerque, NM 87131 USAUniv Colorado, Dept Mol Cellular & Dev Biol, Boulder, CO 80309 USA
Milligan, Erin D.
Leinwand, Leslie A.
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Univ Colorado, Dept Mol Cellular & Dev Biol, Boulder, CO 80309 USAUniv Colorado, Dept Mol Cellular & Dev Biol, Boulder, CO 80309 USA
机构:Off Chief Med Examiner, Dept Forens Biol, New York, NY USA
Kim, Maile
Siegler, Kate
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机构:Off Chief Med Examiner, Dept Forens Biol, New York, NY USA
Siegler, Kate
Tamariz, Jeannie
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Off Chief Med Examiner, Dept Forens Biol, New York, NY USAOff Chief Med Examiner, Dept Forens Biol, New York, NY USA
Tamariz, Jeannie
Caragine, Theresa
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Off Chief Med Examiner, Dept Forens Biol, New York, NY USAOff Chief Med Examiner, Dept Forens Biol, New York, NY USA
Caragine, Theresa
Fernandez, Jill
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NYU, Coll Dent, Dept Pediat Dent, Pediat Outreach Program, New York, NY USA
NYU, Coll Dent, Dept Pediat Dent, Prevent Program, New York, NY USAOff Chief Med Examiner, Dept Forens Biol, New York, NY USA
Fernandez, Jill
Daronch, Marcia
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NYU, Coll Dent, Dept Pediat Dent, New York, NY 10010 USAOff Chief Med Examiner, Dept Forens Biol, New York, NY USA
Daronch, Marcia
Moursi, Amr
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NYU, Coll Dent, Dept Pediat Dent, New York, NY 10010 USAOff Chief Med Examiner, Dept Forens Biol, New York, NY USA