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Lyophilization of Pharmaceuticals and Biologicals

Lyophilization of Pharmaceuticals and Biologicals
Lyophilization of Pharmaceuticals and Biologicals
  • Συγγραφείς: Ward ,  Kevin ,  Matejtschuk
  • ISBN: 9781493989270
  • Εκδότης: Springer
  • Σελίδες: 375
  • Έτος Έκδοσης: 2019
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190,00€
Χωρίς ΦΠΑ: 179,25€
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This detailed volume brings together leading practitioners in the freeze-drying community to address recent progress, not only in new analytical tools and applications of the data derived in cycle design but also in the manufacturing of lyophilized products in the healthcare sector – whether these be therapeutics, vaccines or diagnostic products - and indeed the equipment to deliver this scale of freeze-drying. Areas of focus include analytical and formulation issues, process monitoring and control, as well as post-lyophilization analysis. Written for the Methods in Pharmacology and Toxicology series, chapters include the type of expert advice that leads to superior results in the lab. 
Authoritative and practical, Lyophilization of Pharmaceuticals and Biologicals: New Technologies and Approaches serves as an ideal guide for researchers working in or just seeking an update on this rapidly changing field.

Table of contents (14 chapters)

  • Characterization of Formulations for Freeze-Drying

    Ward, Kevin R. (et al.)

    Pages 1-32

  • Formulation and Process Development for Lyophilized Biological Reference Materials

    Matejtschuk, Paul (et al.)

    Pages 33-55

  • Controlled Ice Nucleation Using ControLyo® Pressurization-Depressurization Method

    Luoma, Jacob (et al.)

    Pages 57-77

  • Alternative Methods of Controlling Nucleation in Freeze Drying

    Pisano, Roberto

    Pages 79-111

  • Tunable Diode Laser Absorption Spectroscopy in Lyophilization

    Kessler, William J. (et al.)

    Pages 113-141

  • Containment Options for the Freeze-Drying of Biological Entities and Potent Materials

    Cherry, Chris

    Pages 143-155

  • Freeze-Drying Systems: Freeze Dryer Interface Design Requirements and Automatic Loading and Unloading Systems (ALUS™)

    Guttzeit, Maik (et al.)

    Pages 157-172

  • Regulatory Aspects of Freeze-Drying

    Awotwe-Otoo, David (et al.)

    Pages 173-192

  • Container and Reconstitution Systems for Lyophilized Drug Products

    McAndrew, T. Page (et al.)

    Pages 193-214

  • Scale-Up of Freeze-Drying Cycles, the Use of Process Analytical Technology (PAT), and Statistical Analysis

    Bourlès, Erwan (et al.)

    Pages 215-240

  • Through Vial Impedance Spectroscopy (TVIS): A Novel Approach to Process Understanding for Freeze-Drying Cycle Development

    Smith, Geoff (et al.)

    Pages 241-290

  • Lyophilization of High-Concentration Protein Formulations

    Garidel, Patrick (et al.)

    Pages 291-325

  • Mechanical Behavior and Structure of Freeze-Dried Cakes

    Hedberg, Sarah H. M. (et al.)

    Pages 327-351

  • High-Resolution Mass Spectrometric Methods for Proteins in Lyophilized Solids

    Balakrishna Chandrababu, Karthik (et al.)

    Pages 353-375

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