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3 334 LAL LAL 338 QCL-1000 LAL 33 LAL 340 C 341 LAL 343 ELx FLx PyroTec 346 WinKQCL 347 CSE 348 /
4 Pyrogen 160 Levin Bang 170 Limulus polyphemus amebocyte lysate LAL /
5 LAL Routine Positive Product Control PPC WinKQCL PPC / Inhibition/Enhancement / Positive Product Control PPC WinKQCL PPC Initial Qualification LAL λ 0.80 /
6 / LAL 0.03 EU/mL / LAL
7 -QCL LAL EU/mL LAL LAL 0.01 EU/mL QCL-1000 LAL 0.1 EU/mL 16 rfc EU/mL LAL FDA, EDQM LAL /
8 nm Kinetic-QCL 6 37, nm WinKQCL / Kinetic-QCL LAL Kinetic-QCL EU/ml CSE ELx808 WinKQCL 6 CSE EU/ml K50-643J Kinetic-QCL 12 CSE, Kinetic-QCL Kinetic Chromogenic LAL Assay (without CSE) 12 tests / ,000 CSE EU/ml Kinetic-QCL 12 Kinetic-QCL Kinetic Chromogenic LAL Assay (without CSE) 12 tests / 8 (30 ml) 3 CSE ,
9 QCL-1000 QCL JP-RSE, CSE nm QCL-1000 LAL FDA LAL EU/ml 16 ELx808 6 CSE EU/ml QCL QCL-1000 Endpoint Chromogenic LAL Assay / 5 2 (30 ml) 2 CSE ,000 /
10 340 nm PYROGENT , 340 nm WinKQCL / PYROGENT LAL EU/ml CSE ELx808 WinKQCL 6 CSE EU/ml N385-8J CSE PYROGENT Kinetic Turbidimetric LAL Assay (without CSE) 200 tests / ,000 CSE EU/ml PYROGENT Kinetic Turbidimetric LAL Assay (with CSE) 100 tests / 2 2 CSE ,
11 rfc LAL ( ) C Pyro Gene rfc 380 nm 440 nm rfc rfc 372 WinKQCL EU/mL FDA, EDQM LAL Pyro Gene rfc Pyro GeneTM rfc LAL C rfc C LAL ELx800 WinKQCL 6 CSE Avg Net Delta RFU Concentration: EU/mL EU/ml EU/ml / rfc 12 PyroGene Recombinant Factor C Endpoint Fluorescent Assay 12 tests 12 rfc6 / 2 2 (30 ml) 2 * FDA USP General Chapter 1225 Validation of Compendial Procedure ,
12 C 170 Detection step common to all BET assays Signal Amplification Steps Measured Characteristic Gel C lot Factor C Factor B Pro-clotting Enzyme Clotting Enzyme Coagulogen Coagulin Clot Formation visual observation / Development Timeline Current Kinetic Turbidimetric Endpoint Chromogenic Kinetic Chromogenic rfc Factor C Factor C Factor C Factor C Factor B Factor B Factor B Fluorogenic Substrate Pro-clotting Enzyme Pro-clotting Enzyme Pro-clotting Enzyme 380 nm Clotting Enzyme Clotting Enzyme Clotting Enzyme 440 nm Difference from previous methods Coagulogen Chromogenic substrate Chromogenic substrate Coagulin Difference from previous methods rfc LAL C LAL Activity of 0.05 µg/ml LRM in EU/ml ,10 Fluorescence (RFU) 100,000 10,000 1,000 Yellow Color Yellow Color Turbidity nm Color 410 nm Color nm Light nm 0.05 Glucan Chromogenic rfc Glucan + Blocker LAL rfc LAL rfc Concentration (EU/ml) Lot HL061M Lot HL076W Lot HL08K Lot HL100W Lot HL131C Lot JL017E Lot JL027A Lot JL043E rfc 8 log net EU/mL
13 LAL PYROGENT LAL 60(+) ( ) PYROGENT ( 2 ) 180 LAL CSE PYROGENT Plus CSE PYROGENT 2 PYROGENT mm CSE EU/ml N14-03J N14-06J 0.06 EU/ml 25 PYROGENT Plus Gel Clot LAL Assay (without endotoxin), single test vials EU/ml 250 CSE PYROGENT Plus Gel Clot LAL Assay 0.03 (without CSE) 250 tests 0.06 EU/ml 250 CSE PYROGENT Plus Gel Clot LAL Assay 0.06 (without CSE) 250 tests , / , / ,000 / CSE EU/ml EU/ml 64 PYROGENT Plus Gel Clot LAL Assay 0.06 (with CSE) 64 tests / 4 CSE , EU/ml 200 PYROGENT Plus Gel Clot LAL Assay 0.03 (with CSE) 200 tests / 4 CSE , EU/ml 200 PYROGENT Plus Gel Clot LAL Assay 0.06 (with CSE) 200 tests / 4 CSE ,
14 ELx808 QCL LAL 6 ELx808 / UV ELx nm nm nm/ Abs nm/ Abs 4 C 50 C WinKQCL cm 3.4 cm 22.2 cm kg S ELx808 ELx808 Reader 80,
15 FLx800 rfc FLx800 rfc 380 nm 440 nm FLx800 WinKQCL FLx nm 4 C 50 C WinKQCL cm 38.1 cm 22. cm kg / FLx800 FLx800 Reader 1,80,
16 PyroTec PyroTec 6 6 PyroTec / PyroTec PyroTec Liquid handling system
17 WinKQCL Kinetic-QCL WinKQCL WinKQCL 521 CFR Part 11 WinKQCL WinKQCL 5 CD * 500,000 WinKQCL 5 Software Package WinKQCL 5 WinKQCL 5 Workgroup License 100, WinKQCL 5 WinKQCL 5 Qualification Manual IQ/OQ/PQ 280, WinKQCL 5 WinKQCL 5 Validation Package CD 500, S IQ/OQ System Qualification Service IQ OQ 135,000 /
18 E.Coli O113 H10 USPRSE 10,000 EU/ E700 USP Reference Endotoxin Standard USP Reference Endotoxin Standard 1 4,000 CSE / N186 Control Standard Endotoxin for PYROGENT Gel Clot LAL Assays CSE 10 ng / 5 25, USP USP EU-10,000 EU E.coli O55 B USP 1,250,000 EU/ Endotoxin 1,250,000 EU/ USP 1,000 10,000 EU/vial Endotoxin Challenge Vials 1,000 10,000 EU/
19 PYEOAPERSE Dispersing Agent 5 ml 5 32, S S β-g- β-g-blocker MgCl2 MgCl2 10 mm Solution Tris Buffer 50 mm 5 ml 5 28, mm 30 ml 1 50 mm 30 ml 1 5,000 5,000 / W LAL Reagent Water 30 ml 1 1,600 W LAL Reagent Water 100 ml 1 2,
20 LAL Reagent Reservoirs 10 2,400 / N201 N205 N EU/well LAL Reagent Grade Multi-well Plates Pyrogen-free Test Tubes mm Pyrogen-free Test Tubes mm Pyrogen-free Test Tubes 50 45, , , ,
21 80-507L 10 ml Sample Containers 10 ml 25 11, µl Eppendorf µl Biopur Pipette Tips 50-1,000 µl Eppendorf µl Biopur Pipette Tips 6 / 5 6 / 5 18,000 20,000 /
22 Notes /
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