Cedex Bio HT Analyzer - The Benefit of Using Next Generation Cell Culture Analysis Technical Case Review
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1 Cedex Analyzer - The Benefit of Using Next Generation Cell Culture Analysis Technical Case Review Becky Moore, PhD Scientist III, Biology 17Sept Life Technologies
2 Cell Culture Analysis Background Nova Bioprofile 400 System Gluc, Lac, ph, Na +, K +, Gln, Glu, NH 4, Osm Required significant maintenance of two analyzers Inconsistent results for some assays ForteBio Octet System IgG titer Sample prep required Inconsistent results if outside linear range of standard curve HPLC/UPLC Confirmation of Nova and Octet system results Sample prep required Increased turn-around time Reliability Speed Requirements Low maintenance Single analyzer 2 Life Technologies 9/17/2013
3 What is the Cedex Analyzer? Analyzer which gives high accuracy, high precision results Increased sensitivity and reproducibility vs comparable instruments tested Includes cell culture nutrient and substrate measurements Walk away analyzer with minimal daily maintenance requirements Instrument based on 20 years of experience in hospital systems 3 Life Technologies 9/17/2013
4 What does the Do? Cedex Bioprocess Analyzer is an automated machine which can analyze up to ten different metabolites at one time from a single sample Extensive range capability due to automatic dilution function Metabolite Range(non-diluted) Range ( diluted) Glucose mg/L up to 75.0 g/l Glutamate mg/l up to 7500 mg/l Glutamine mg/l up to 7500 mg/l IgG LB 4-100mg/L N/A IgG HB mg/l up to 16g/L Lactate mg/l up to 14 g/l LDH 20-1,000 U/L up to 10,000 U/L Ammonia mg/l up to 1 g/l Sodium 600 mg/l mg/l N/A Potassium 24 mg/l mg/l N/A 4 Life Technologies 9/17/2013
5 Advantages of Demonstrated better accuracy than Nova and Octet systems (confirmed by HPLC) Increased range for IgG determination (can detect low ranges and is accurate for high ranges) Automatic dilutions eliminate sample prep Less sample needed compared to Nova and Octet systems combined (400µL compared to ~1mL) Less variability of results over time Excellent phone and in-person service 5 Life Technologies 9/17/2013
6 Interactive screen Minimal training General Information Easily see process results, status of sample, amount of reagents No preparation of samples Run time of samples varies depending on number of parameters to be tested and if dilutions are needed Easily copy and paste order information for multiple samples Early release evaluation 1. Experimental Sample Comparison 2. QC Data Comparison 3. Internal Spent Medium Control 4. Maintenance Data included within this presentation is based on experiments performed at Life Technologies 6 Life Technologies 9/17/2013
7 Comparison #1 Experimental Sample Comparison 7 Life Technologies 9/17/2013
8 Overview Assessment of multiple cell culture media experiment conducted 22 conditions run in duplicate CHO-S IgG and DG44 EPO cells tested Day 10 data picked randomly to compare > vs. Nova vs. Octet systems Additional data tested (not shown) 17 conditions, DG44 IgG cell line, Day 17 analysis 8 Life Technologies 9/17/2013
9 Glutamate results comparable between Nova system and (if within range on Nova ) 20 Nova Data outside Nova range 18 Data outside Nova range Glutamate (mmol/l) Condition # 9 Life Technologies 9/17/2013
10 Glutamine data inconsistent from Nova 2.5 Nova No data given by Nova 2 No data given by Nova Glutamine (mmol/l) Condition # 10 Life Technologies 9/17/2013
11 Glutamine Trends Over Time BioHT Nova Glutamine (mmol/l) Glutamine (mmol/l) Run Day Run Day was reliable and consistent over time 11 Life Technologies 9/17/2013
12 Glucose data comparable between Nova and 20 Nova Glucose (g/l) Condition # 12 Life Technologies 9/17/2013
13 Lactate data comparable between Nova and 3.5 Nova Lactate (g/l) Condition # 13 Life Technologies 9/17/2013
14 Ammonia data comparable between Nova and 18 Nova Ammonia (mmol/l) Condition # 14 Life Technologies 9/17/2013
15 Sodium data comparable between Nova and 160 Nova Sodium (mmol/l) Condition # 15 Life Technologies 9/17/2013
16 Potassium data comparable between Nova and 18 Nova Potassium (mmol/l) Condition # 16 Life Technologies 9/17/2013
17 IgG titer data comparable between Octet and with variation at higher ranges Octet IgG (µg/ml) Condition # 17 Life Technologies 9/17/2013
18 IgG validated with HPLC IgG Titer HPLC CD OptiCHO + EFA CD OptiCHO + EFA + FMTE CD OptiCHO + EFA CD OptiCHO + EFA + FMTE CD OptiCHO + EFA CD OptiCHO + EFA + FMTE Octet Day 13 Day 15 Day 17 IgG Standards Human IgG (FC region) HPLC Purified IgG molecule standard Octet Jackson IgG standard 18 Life Technologies 9/17/2013
19 IgG Titer Trends Over Time IgG Low + High Octet IgG Run Day Run Day able to capture low titer levels earlier in culture (8 days earlier) Octet sometimes slopes downward later in culture for unknown reasons Octet duplicates (biological) show variability (5&6, 11&12, 17&18) 19 Life Technologies 9/17/2013
20 Summary - 1 reliably gave results for each sample and test Automatic dilutions ensure data falls within range of instrument Nova system gave unreliable results for glutamine Reported very little data Glutamate results fell outside of the Nova range Nova system and had comparable results for glucose, lactate, ammonia, sodium and potassium Octet system and had comparable IgG titer measurements with the exception of higher ranges Due to non-linear standard curve at higher titer levels in Octet system Validated with HPLC Biological duplicates very similar with 20 Life Technologies 9/17/2013
21 21 Life Technologies 9/17/2013 Comparison #2 QC Data Comparison
22 Nova & QC (2-3 level) Consistent for All Tests Nova QC Data QC Data glucose - 1 lactate AMM 1 AMM 2 Units (g/l or mmol/l) NH4-1 K - 1 glucose - 2 lactate - 2 NH4-2 K - 2 glucose - 3 lactate - 3 NH4-3 Units GLNB 1 GLNB 2 GLNB 3 GLUB 1 GLUB 2 GLUB 3 GLC3B 1 GLC3B 2 K-D Aug 29-Aug 3-Sep 8-Sep 13-Sep 18-Sep 23-Sep K - 3 Gln - 4 Glu /14 8/19 8/24 8/29 9/3 9/8 9/13 9/18 9/23 K-D 2 LAC2B 1 LAC2B 2 Nova QC Data QC Data mmol/l Na - 1 Na - 2 Na - 3 Units LDH2B 1 LDH2B 2 NA-D 1 NA-D Aug 29-Aug 3-Sep 8-Sep 13-Sep 18-Sep 23-Sep 0 8/14 8/19 8/24 8/29 9/3 9/8 9/13 9/18 9/23 22 Life Technologies 9/17/2013
23 IgG QC (2 level) validated with HPLC mg/l IGGHB HPLC-Hi IGGLB HPLC-Lo Sample Day 23 Life Technologies 9/17/2013
24 Validated with Nova QC Samples Value Nova QC Range In Range? GLC3B g/l level Y K-D mmol/l level Y LAC2B g/l level Y NA-D mmol/l level Y NH3B mmol/l level Y GLC3B g/l level Y K-D mmol/l level Y LAC2B g/l level Y NA-D mmol/l level Y NH3B mmol/l level Y GLC3B g/l level Y K-D mmol/l level Y LAC2B g/l level Y NA-D mmol/l level Y NH3B mmol/l level Y GLNB mmol/l level Y GLUB mmol/l level Y GLNB mmol/l level Y GLUB mmol/l level Y 24 Life Technologies 9/17/2013
25 Summary - 2 and Nova systems both reliable for QC samples Ammonia, glutamine, glucose, glutamate, sodium, potassium reliable for IgG No IgG QC available for Octet for comparison able to run LDH samples Centrifugation required 25 Life Technologies 9/17/2013
26 Comparison #3 Internal Spent Medium Control 26 Life Technologies 9/17/2013
27 Overview Comparative experiment run on, Nova, and Octet systems Spent medium stock run on each instrument QC performed every day on and two Nova systems Analytical (HPLC, UPLC, YSI ) data for comparison Calibrations performed as needed on (new cassettes) 27 Life Technologies 9/17/2013
28 Inconsistent Glucose, Lactate, Glutamine and Glutamate from Nova systems; Glutamine near LOQ g/l Glucose Nova #1 Nova #2 YSI g/l Lactate Nova #1 Nova #2 YSI Days Days Glutamine Glutamate mmol/l Nova #1 Nova #2 UPLC mmol/l Nova #1 Nova #2 UPLC Days Days BioHT & UPLC LOQ = 0.41 mmol/l 28 Life Technologies 9/17/2013
29 Inconsistent data for K & Na from Nova system 1; Inconsistent data from Octet system Ammonia IgG Titer mmol/l Nova #1 Nova #2 UPLC Octet HPLC Days Days g/l Sodium Nova #1 Nova #2 mmol/l Potassium Nova #1 Nova # Days Days 29 Life Technologies 9/17/2013
30 Summary - 3 Nova analyzers showed inconsistent data compared to each other and when compared to the The Octet IgG was inconsistent compared with The gave consistent results over time with little deviation Spent medium confirmation by analytical Confirmed accuracy of glucose, glutamate, lactate, IgG Deviation observed with glutamine (due to below LOQ) and ammonia 30 Life Technologies 9/17/2013
31 31 Life Technologies 9/17/2013 Comparison #4 Maintenance
32 maintenance is significantly less than for Nova Unit Maintenance (hours/week) Cedex 1.1 Nova Bioprofile ForteBio Octet 0 Maintenance includes daily, weekly and additional handson time over 2 week evaluation was serviced by technician in <24 hours 32 Life Technologies 9/17/2013
33 Test Experimental Samples Overall Evaluation Nova System Octet System **** ** *** QC Data **** *** N/A Internal Spent Media **** * * Comments Glutamine & Glutamate unreliable in Nova Late IgG questionable in Octet Early IgG available from reliable, confirmed by analytical No LDH available for Nova comparison No IgG comparison for Octet Nova unreliable for many assays Octet shows variable over time, requires sample prep and is limited in lower range Analytical confirmed data Maintenance *** * **** Daily, weekly and additional maintenance Support **** *** N/A has excellent phone and in-person support Nova only supported by phone Average Life Technologies 9/17/2013
34 Over the last 6 months used routinely Conclusions Given confidence in data resulting in more precise culture maintenance Reduced daily maintenance and no sample prep relieves daily stress Phasing out Nova instruments Acknowledgements Roche team > Dan Sejas > Jolene Osterberger > Miranda Kheradmand > Elizabeth Strum Life Technologies R&D > Ryan Boniface > Jim Smith > Paul Gulde > Jaime Goldfuss > Aaron Schrader > Shawn Barrett 34 Life Technologies 9/17/2013
35 2013 Life Technologies Corporation. All rights reserved. The trademarks mentioned herein are the property of Life Technologies Corporation and/or its affiliate(s) or their respective owners. Cedex is for use in quality control / manufacturing process only. Cedex is a registered trademark of Roche Diagnostics GmbH. Nova and BioProfile are registered trademarks of Nova Biomedical Corporation. ForteBio and Octet are registered trademarks of Pall ForteBio Corp. 35 Life Technologies 9/17/2013
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