PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
Current issue
Showing 1-3 articles out of 3 articles from the selected issue
Regular Article
  • Gregory DEVULDER, Kevin WILLIAMS
    2020 Volume 22 Issue 1 Pages 1-5
    Published: 2020
    Released: June 26, 2020

    Since the initial exploratory use of LAL for radiopharmaceutical testing was found, several widespread paradigm changes have occurred in the past 50 years including (a) the LAL test supplanted the rabbit pyrogen test (RPT) as a method of precluding fever reactions in patients subject to injectable drug treatments. However, the source material, horseshoe crab, is a Red List registered species (endangered species). Therefore, a test method alternative to the LAL teat that can be continuously supplied has been sought.

    “Endotoxin Testing Using Sustainable Reagents based on Recombinant Horseshoe Crab Factor C” is introduced in this report as an alternative method to the LAL test. The main advantages of the rFC method are introduced below.

     (a) sustainability via “at will” production,

     (b) attributes of a natural biosensor,

     (c) absence of Factor G and thus beta-glucan reactivity,

     (d) sensitivity to endotoxin detection

     (e) ability to automate and iterate

     (f) simplification of the test milieu

     (g) ease of validation.

    The usefulness of the rFC method has already been proved, while the death of the horseshoe crab due to environmental changes is unavoidable, and the continued use of the horseshoe crab is impossible. The pharmaceutical industry should be prepared for this switch from LAL to rFC. And this need has been clarified by regulatory agencies.

    Download PDF (724K)
Topics Review
  • Hiroyuki ISHIHARA, Taishi NIIMI, Naotaka CHINO, Miho KAI, Yuki SOMA, E ...
    2020 Volume 22 Issue 1 Pages 6-11
    Published: 2020
    Released: June 26, 2020

    We developed a novel spray-type dextrin hydrogel-based adhesion barrier designed to create a site-specific barrier on a target. Our novel hydrogel is composed of Powder A, which mainly contains N-hydroxysuccinimide-modified carboxymethyl dextrin and trehalose as a stabilizing agent, and Powder B, which is composed of sodium carbonate and sodium hydrogen carbonate. The spray device has several unique specifications that can be used under laparoscopic surgery. Furthermore, the shape and the appearance are characteristic so that this device can be appropriately used in a clinical situation. Here, we introduce the development process of a novel spray-type adhesion barrier as the case study of medical device.

    Download PDF (2109K)
Book Review