Whitepaper: Controlled thawing of drug products in environmental chambers

This whitepaper explores the process of discovering a methodology for thawing an ultra-cold drug product under tight timelines to help ensure successful patient delivery. 

Considerations included: 

  • A thaw time of 15 hours or less 
  • Maintenance of acceptable time-in-refrigeration and time-out-of-refrigeration limits
  • Multi-variate-controlled thaw procedure to ensure minimal impact on critical quality characteristics

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