E-Book

Lyophilization of pharmaceuticals and biologicals: new technologies and approaches [electronic resource]

  • Ward, Kevin R. , Matejtschuk, Paul
  • Humana Press
  • 2019
Lyophilization of pharmaceuticals and biologicals: new technologies and approaches [electronic resource]

초록

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.

목차

Characterization of formulations for freeze-drying / Kevin R. Ward and Paul Matejtschuk
Formulation and process development for lyophilized biological reference materials / Paul Matejtschuk, Kiran Malik, and Chinwe Duru
Controlled ice nucleation using ControLyoʼ pressurization-depressurization method / Jacob Luoma, Graham Magill, Lokesh Kumar, and Zakaria Yusoff
Alternative methods of controlling nucleation in freeze drying / Roberto Pisano
Tunable diode laser absorption spectroscopy in lyophilization / William J. Kessler and Emily Gong
Containment options for the freeze-drying of biological entities and potent materials / Chris Cherry
Freeze-drying systems : freeze dryer interface design requirements and automatic loading and unloading systems (ALUS) / Maik Guttzeit, Carolin Wolf, Johannes Selch, and Thomas Beutler
Regulatory aspects of freeze-drying / David Awotwe-Otoo and Mansoor Khan
Container and reconstitution systems for lyophilized drug products / T. Page McAndrew, Douglas Hostetler, and Frances L. DeGrazio
Scale-up of freeze-drying cycles, the use of process analytical technology (PAT), and statistical analysis / Erwan Bourle`s, Gael de Lannoy, Bernadette Scutella` , Fernanda Fonseca, Ioan Cristian Trelea, and Stephanie Passot
Through vial impedance spectroscopy (TVIS): a novel approach to process understanding for freeze-drying cycle development / Geoff Smith and Evgeny Polygalov
Lyophilization of high-concentration protein formulations / Patrick Garidel and Ingo Presser
Mechanical behavior and structure of freeze-dried cakes / Sarah H. M. Hedberg, Sharmila Devi, Arnold Duralliu, and Daryl R. Williams
High-resolution mass spectrometric methods for proteins in lyophilized solids / Karthik Balakrishna Chandrababu, Rajashekar Kammari,Yuan Chen, and Elizabeth M. Topp.