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Emerging Freeze-Drying Process Development and Scale-up Issues

  • Review Article
  • Theme: Sterile Products: Advances and Challenges in Formulation, Manufacturing, Devices and Regulatory Aspects
  • Published:
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Abstract

Although several guidelines do exist for freeze-drying process development and scale-up, there are still a number of issues that require additional attention. The objective of this review article is to discuss some emerging process development and scale-up issue with emphasis on effect of load condition and freeze-drying in novel container systems such as syringes, Lyoguard trays, ampoules, and 96-well plates. Understanding the heat and mass transfer under different load conditions and for freeze-drying in these novel container systems will help in developing a robust freeze-drying process which is also easier to scale-up. Further research and development needs in these emerging areas have also been addressed.

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Notes

  1. Treated with methylated spirit and air dried.

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Author information

Author notes

  1. Sajal Manubhai Patel

    Present address: MedImmune, Inc., 1 Medimmune Way, Gaithersburg, Maryland, 20878, USA

Authors and Affiliations

  1. Department of Pharmaceutical Sciences, School of Pharmacy, University of Connecticut, 69 North Eagleville Road, Storrs, Connecticut, 06269, USA

    Sajal Manubhai Patel & Michael J. Pikal

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  1. Sajal Manubhai Patel
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  2. Michael J. Pikal
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Correspondence to Sajal Manubhai Patel.

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Guest Editors: Lavinia Lewis, Jim Agalloco, Bill Lambert, Russell Madsen, and Mark Staples

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Patel, S.M., Pikal, M.J. Emerging Freeze-Drying Process Development and Scale-up Issues. AAPS PharmSciTech 12, 372–378 (2011). https://doi.org/10.1208/s12249-011-9599-9

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  • DOI: https://doi.org/10.1208/s12249-011-9599-9

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