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The Effect of Loading Process on Product Collapse During Large-scale Lyophilization by Alexis J. Wallen; Susan H. Van Ocker; Jessica R. Sinacola; Bret R. Phillips is a Chemistry article available to read on EtoBox.

What is The Effect of Loading Process on Product Collapse During Large-scale Lyophilization about?

Lyophilization is a process commonly used by the pharmaceutical industry in order to enhance product stability by removal of the solvent, typically water. Previous studies have investigated several causes of variability during the lyophilization process, including freezing, vial placement within the lyophilization chamber, primary drying, and secondary drying. These differences can contribute to variability in cake appearance, moisture results, and stability profiles. This study investigates the effect of lyophilization chamber loading on inhomogeneity in final product appearance. For a complex biological product which was initially flash-frozen and subsequently loaded into a large-scale lyophilization chamber, it was found that the method of chamber loading had a significant effect on cake appearance for the first vials loaded into the chamber, which is attributed to inadvertent annealing during the lyophilizer loading step. It is hypothesized that inadvertent annealing led to a decrease in the surface area of the dried cake, which in turn led to product collapse during secondary drying.

Who reads The Effect of Loading Process on Product Collapse During Large-scale Lyophilization?

Author

Alexis J. Wallen; Susan H. Van Ocker; Jessica R. Sinacola; Bret R. Phillips

Publisher

John Wiley and Sons; Elsevier ; Elsevier Inc.; Elsevier BV (ISSN 0022-3549)

Published

2009

Language

EN

Field

Chemistry (Physical Sciences)