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New Processes for Freeze-Drying in Dual-Chamber Systems.

T Werk1, I S Ludwig2, J Luemkemann2

  • 1Pharmaceutical Technology, University of Basel, Basel, Switzerland; Pharmaceutical Development & Supplies, F. Hoffmann-La Roche Ltd., Basel, Switzerland; currently at Lonza AG, Drug Product Services, Basel, Switzerland; and Institute for Medical Technology, Heidelberg University and Mannheim University of Applied Sciences, Mannheim (Germany) tobias.werk@roche.com.

PDA Journal of Pharmaceutical Science and Technology
|February 12, 2016
PubMed
Summary
This summary is machine-generated.

Improved freeze-drying processes for dual-chamber systems significantly reduce manufacturing costs and time. These methods enhance heat transfer and homogeneity, making lyophilized biologics more accessible for self-administration.

Keywords:
Aseptic processingBiologicsBiopharmaceuticalDual-chamber syringeDual-chamber systemFreeze-dryingSmall-volume parenterals

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Area of Science:

  • Pharmaceutical manufacturing
  • Biologics processing
  • Lyophilization technology

Background:

  • Dual-chamber systems enable self-administration of lyophilized biologics but face complex and costly manufacturing.
  • Limited commercialization of dual-chamber systems is attributed to intricate drug product manufacturing processes.

Purpose of the Study:

  • To describe two improved processes for freeze-drying pharmaceuticals in dual-chamber systems.
  • To address challenges in heat transfer during lyophilization within dual-chamber systems.
  • To reduce the investment costs associated with dual-chamber system fill-finish equipment.

Main Methods:

  • Developing tray-filling based processes for dual-chamber systems.
  • Optimizing heat transfer via needle-down orientation with an aluminum block.
  • Implementing external freeze-drying in a metal cartridge followed by filling.

Main Results:

  • Both improved processes demonstrated efficient metal-mediated heat transfer.
  • Increased batch homogeneity and consistent sublimation rates were observed.
  • Drying times were reduced by half compared to established methods.
  • Ice crystal size was influenced by the high heat capacity of metal carriers, leading to smaller crystals.

Conclusions:

  • The proposed processes offer efficient heat transfer and improved homogeneity for freeze-drying in dual-chamber systems.
  • Significant reductions in drying times were achieved, potentially halving process duration.
  • These advancements can substantially decrease investment costs for dual-chamber system manufacturing equipment.