Literature DB >> 4048205

Guideline for validation of the LAL test as an end-product endotoxin test for human and biological drug products.

T E Munson.   

Abstract

The draft guideline sets forth acceptable conditions for use of the Limulus Amebocyte Lysate (LAL) test. It also describes procedures for using this methodology as an end-product endotoxin test for human (including biological products) and animal injectable drugs, and medical devices. Manufacturers are allowed to switch from the rabbit pyrogen test to the LAL test, without preclearance from FDA, if they follow the guideline.

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Year:  1985        PMID： 4048205

Source DB:  PubMed          Journal:  Prog Clin Biol Res        ISSN： 0361-7742


  7 in total

1.  Specificity of the tuberculin skin test is modified by use of a protein cocktail containing ESAT-6 and CFP-10 in cattle naturally infected with Mycobacterium bovis.

Authors:  S Flores-Villalva; F Suárez-Güemes; C Espitia; A O Whelan; M Vordermeier; J A Gutiérrez-Pabello
Journal:  Clin Vaccine Immunol       Date:  2012-03-14

2.  Functional evaluation of a recombinant fungal immunomodulatory protein from L. rhinocerus produced in P. pastoris and E. coli host expression systems.

Authors:  Udochukwu Camillius Ejike; Chong Joo Chan; Crystale Siew Ying Lim; Renee Lay Hong Lim
Journal:  Appl Microbiol Biotechnol       Date:  2021-03-25       Impact factor: 4.813

3.  Treatment of neuroinflammation by soluble tumor necrosis factor receptor Type II fused to a thermally responsive carrier.

Authors:  Mohammed F Shamji; Liufang Jing; Jun Chen; Priscilla Hwang; Odelia Ghodsizadeh; Allan H Friedman; William J Richardson; Lori A Setton
Journal:  J Neurosurg Spine       Date:  2008-08

4.  Immunogenicity of intrathecal plasmid gene delivery: cytokine release and effects on transgene expression.

Authors:  Travis S Hughes; Stephen J Langer; Salla I Virtanen; Raymond A Chavez; Linda R Watkins; Erin D Milligan; Leslie A Leinwand
Journal:  J Gene Med       Date:  2009-09       Impact factor: 4.565

5.  A Step-by-Step Approach to Improve Clinical Translation of Liposome-Based Nanomaterials, a Focus on Innate Immune and Inflammatory Responses.

Authors:  Giacomo Della Camera; Dorelia Lipsa; Dora Mehn; Paola Italiani; Diana Boraschi; Sabrina Gioria
Journal:  Int J Mol Sci       Date:  2021-01-15       Impact factor: 5.923

Review 6.  Mesenchymal stem or stromal cells: a review of clinical applications and manufacturing practices.

Authors:  Ratti Ram Sharma; Kathryn Pollock; Allison Hubel; David McKenna
Journal:  Transfusion       Date:  2013-10-16       Impact factor: 3.157

Review 7.  The Safety and Toxicity of Phage Therapy: A Review of Animal and Clinical Studies.

Authors:  Dan Liu; Jonas D Van Belleghem; Christiaan R de Vries; Elizabeth Burgener; Qingquan Chen; Robert Manasherob; Jenny R Aronson; Derek F Amanatullah; Pranita D Tamma; Gina A Suh
Journal:  Viruses       Date:  2021-06-29       Impact factor: 5.048
  7 in total

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