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Celsis Outlines the Top Five Advantages of Cryo-plateable Hepatocytes
Date:6/16/2009

aw from the same product lot for consistent, simultaneous research worldwide.
  • FDA Equivalency. The use of cryopreserved hepatocytes is recognized as equivalent to using freshly isolated hepatocytes. Acknowledging this trend, the U.S. Food and Drug Administration (FDA) drafted a Guidance for Industry(1) in 2006 advising that cryopreserved tools are a viable and acceptable alternative to fresh research products, especially in metabolism, toxicity and drug-drug interaction testing. Several large pharmaceutical companies have adopted cryopreserved hepatocytes as their primary model for stability, transport and induction studies as evidenced in peer-reviewed literature. As researchers recognize the benefits of cryopreserved hepatocytes for traditional ADME-Tox studies, a broader range of new applications will be realized like high-throughput screening (HTS) and high-content screening (HCS).

  • In summary, the uncertainties associated with fresh hepatocytes - lack of availability of donors, difficulty matching profiles, unknown enzymatic activities, inability to repeat experiments from the same donor and time restrictions - often mean researchers may unknowingly rely on less-than-ideal donors or resected tissue without serology reporting. With cryopreserved hepatocytes, pharmaceutical manufacturers no longer have to compromise safety, scheduling or productivity. Given their many advantages, the benefits of using cryopreserved suspended and plateable hepatocytes outweigh those of fresh products and should be strongly considered.

    For More Information

    Visit Celsis' online Cryo Advantage resource center at www.celsis.com/ivt and download the following poster presentations from Celsis' experts:

    • The Effects of Cryopreservation on P450 Oxidation and Phase II Conjugation Acti
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    SOURCE Celsis International plc
    Copyright©2009 PR Newswire.
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