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Evaluation of the immuno-stimulatory potential of stopper extractables and leachables by using dendritic cells as readout.

Author: KarleAnette, KropshoferHarald, MaederKarsten, MahlerHanns-Christian, MuellerRobert, RossAlfred, VogtAnne

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Overview

The study investigated the potential of extractables and leachables from pharmaceutical stoppers to act as "danger signals" for dendritic cells, a type of immune cell. The study found that stopper extractables did not act as danger signals for dendritic cells under extraction or leaching conditions. However, degradation products of polysorbate 80, including oleic acid and its byproducts, were found to potentially stimulate these immune cells, but only under very accelerated conditions (100 degrees C for 4 days). This degradation was not observed under real-time conditions, so the authors do not believe their findings have direct safety implications for polysorbate-containing formulations in clinical practice.
Paper Details　
Original Abstract of the Article :
Recombinant protein pharmaceuticals may bear some risks and undesirable side effects, such as the appearance of immunogenic reactions. The increased incidence of antibody-mediated pure red cell aplasia (PRCA) outside the United States after administration of a human serum albumin (HSA)-free EPREX (r...See full text at original site
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引用元：
https://pubmed.ncbi.nlm.nih.gov/19226629

データ提供：米国国立医学図書館（NLM）

The Immune System's Response to Stopper Extractables

The world of pharmaceuticals is a delicate dance, balancing the potential benefits of medications with the risks of adverse effects. This study investigates the potential for stopper extractables and leachables, substances that can migrate from a drug container into the drug product, to trigger an immune response. Researchers used dendritic cells, which are important for initiating immune responses, to assess the immunostimulatory potential of these substances.

No Alarm Bells Ringing in the Desert

The study found that stopper extractables and leachables did not trigger a 'danger signal' in dendritic cells, suggesting that they are unlikely to cause an immune response. This finding is reassuring, as it indicates that these substances are unlikely to cause adverse effects in patients. It's like exploring a desert landscape and finding that the sand is safe to walk on, free of any hidden dangers.

A Safe Oasis for Medications

The study's findings provide valuable reassurance regarding the safety of drug containers. The fact that stopper extractables and leachables did not induce an immune response in dendritic cells suggests that they are unlikely to pose a significant risk to patients. This information is important for ensuring the safety and efficacy of medications. It's like discovering a well-protected oasis in the desert, providing a safe haven for travelers.

Dr.Camel's Conclusion

This study adds to our understanding of the safety of drug containers. It's like finding a safe passage through the desert, ensuring that our medications are protected and free from potential contaminants.

Date :
  1. Date Completed 2010-01-04
  2. Date Revised 2017-11-16
Further Info :

Pubmed ID

19226629

DOI: Digital Object Identifier

S0022-3549(16)33113-6

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