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fvtm.bu.edu.eg

تتقدم السيدة الأستاذ الدكتور أماني عبدالرحمن عباس - عميد كلية الطب البيطري بأطيب التهاني للسادة وكلاء الكلية، وأعضاء هيئة التدريس، والهيئة المعاونة، والجهاز الإداري، وجميع طلاب الكلية بمناسبة حلول ذكرى المولد النبوي الشريف أعاده الله علينا وعلى الأمة الإسلامية ومصرنا الغالية بالخير واليُمن والبركات،...

arjournals.org

Advanced Research

journal.pda.org

Endotoxin testing by recombinant factor C (rFC) is increasing with the addition of new suppliers of reagents. By use of a recombinantly produced factor C , based on the sequence of a coagulation enzyme present in horseshoe crab amebocyte lysates, the rFC tests are designed as substitutes for the traditional Limulus amebocyte lysate (LAL)/ Tachypleus amebocyte lysate tests based on horseshoe crab blood. Comparative testing of samples with both the LAL and recombinant reagents has shown a high degree of correlation, suggesting that use of rFC is comparable to the more traditional LAL tests and may be technologically superior. Recombinant factor C does not recognize the factor G pathway, the alternate coagulation pathway that the lysate reagents detect. This feature allows rFC to detect endotoxin more selectively. As a recombinantly produced material, it avoids the use of the horseshoe crabs required for lysate production, thereby protecting this species, which is at risk in some parts of the world. Recombinant factor C is expected to further benefit from a more sustainable supply chain based upon a robust biotechnological production process. We summarize here the results of many studies that evaluated the use of recombinant technology for the detection of environmental endotoxin. Additionally, we include a review of the current compendia and regulatory status of the recombinant technologies for use in the quality control of pharmaceutical manufacturing. Our analysis confirms that the recombinant technologies are comparable in protecting patient safety.

e-iji.net

international journal of instruction