Automation Supporting Single Cell Cloning Experiments and QbD-Based Bioprocess Development

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1 Automation Supporting Single Cell Cloning Experiments and QbD-Based Bioprocess Development Dr. Roland Schaefer Roche Diagnostics, Mannheim, Germany ELRIG High Throughput BioProcess Development, June 22, 2011

2 1. Introduction 2. Cell maintenance / Single Cell Cloning 3. QbD approach 4. Measurement technology 5. Bioprocess automation 6. Summary

3 Introduction Bioprocess Production Process Development and Production Online Analytics Cell line development Process Development & Small Scale Production Large Scale Production Research: Biological background of disease Target Validation Compound Screening Preclinical Trials Clinical Trials Research and Development General Biomedical Cellular Research

4 1. Introduction 2. Cell maintenance / Single Cell Cloning 3. QbD approach 4. Measurement technology 5. Bioprocess automation 6. Summary

5 Expectations of an Automated System High Flexibility Saving space Reduce costs Increase throughput Save time Less personnel Error free!

6 Automated Cloning and Cell Maintenance Requirements at the Fraunhofer IME, Aachen Plating and passaging of cells Handling and merging of different media and additives (including different volume handling and viscous liquid) Microscope analysis (cell imager, automated microscope) Single cell cloning (limiting dilution, clone picking, clone tracking) Handling different types of plates (1-384 MTP) and roboflask Creation of several different dilutions Automatic interaction with incubator, refrigerator, imager and computer Reader inclusive luminescence and absorption (useful for different applications, e.g., vitality tests, Mycoplasma testing, ) Sterile working and alarm system

7 Automated Cloning and Cell Maintenance Brightfield and three fluorescence filters Microscopy at 4x,10x, 20x and 40x magnification Compatible for plates and roboflask Microscopic analysis (morphology, contamination, cell growth, etc.) Automated cell robot Single cell cloning (imaging) Clone tracing Cell amount determination Product quantification to select high-producers Efficiency of transfection Automated interaction with robot Image and text by FHG IME

8 Workflow PEG-Fusion 2 weeks (HT-Selection) First ELISA- Screening One day Positive clones, plated out in 24-well plates One day Cell count determination Limiting Dilution via Robot (3 cells/well) One day Transfer of monoclonal/ good producing cells into 24-well plates (Robot) Monoclonality can be determined via Backtracking (Images) One day Second ELISA- Screening Screening via Imager (every 2 days) days Brightfield Fluorescence Day 8 Day 6 Images and drawings by FHG IME Day 4 Day 1

9 Semi-solid media: Detecting growth and antibody production Colony Size Colony Intensity Colonies grown in semi-solid media are analyzed for size, growth speed and antibody production capability with a single measurement. Clones are picked and transferred Images by FHG IME

10 Upscaling Process Transfection/ Hybridization Colony Growth Colony Selection Upscaling Media/Process Optimization Transfection Efficiency Single Cell Seeding Clone Parameters: Complete Documentation, Proliferation Studies Check Monoclonality Size, Growth, Protein Expression Cell Confluence Measurement Media Optimization

11 1. Introduction 2. Cell maintenance / Single Cell Cloning 3. QbD approach 4. Measurement technology 5. Bioprocess automation 6. Summary

12 Quality by Design (QbD): What is this all about? Process Parameters Quality Attributes CPPs 1 CQAs 2 Proven Acceptable Ranges CPPs CQAs Acceptance criteria 1 Critical process parameters 2 Critical quality attributes

13 Steps to the design space: Process Parameters All Process Parameters (PPs) Potentially Critical Process Parameters (pcpps) Range Studies Critical Process Parameters Design (CPPs) Spaceand their acceptable ranges Process Development / Scale down model Risk Analysis Process Characterization Critical Process Parameters (CPPs) The multidimensional combination of all PARs define the Design Space of the process. Working within this space leads to acceptable product quality Movement out of the Design Space is considered to be a change and would normally initiate a regulatory postapproval change process. (ICH Q8 Pharmaceutical development)

14 1. Introduction 2. Cell maintenance / Single Cell Cloning 3. QbD approach 4. Measurement technology 5. Bioprocess automation 6. Summary

15 Metabolic / Substrate Profiling concentration glucose glutamine lactate ammonia Metabolic products build up (growth inhibition) optimum Substrate limitation (growth inhibition) sampling time [fermentation days] Monitoring metabolites and substrates to avoid limitations or undesired build up

16 Method Validation Recovery Cedex Bio Analyzer versus an Enzyme- Membrane Analyzer

17 v5 Method Validation Recovery Cedex Bio Analyzer versus an Enzyme- Membrane Analyzer

18 Folie 17 v5 Same as v4. vanderr1;

19 System Suitability Test for Cell Density Measurement Analyzer calibration with traceable material: Density Reference Standard Beads Analyzer linearity check: Control Beads Density DRSB CB high density CB mid density CB low density Time 18

20 Integrated Analysis of SST Results Results from SST measurements can be tracked over time...with a list of all measurement results associated with a particular SST checkpoint, or......with a Trending chart that shows the measurement results in relation to the upper and lower limits and the target value.

21 1. Introduction 2. Cell maintenance / Single Cell Cloning 3. QbD approach 4. Measurement technology 5. Bioprocess automation 6. Summary

22 BaychroMAT Fully automated analytics (closed-loop)

23 BaychroMAT Automation of steel and glass bioreactors

24 Fed-Batch Fermentation without BaychroMAT Data modified by BTS due to confidentiality reasons

25 Fed-Batch Fermentation with BaychroMAT Data modified by BTS due to confidentiality reasons

26 Fed-Batch Fermentation with BaychroMAT + PAT Data Management Data modified by BTS due to confidentiality reasons

27 Benefits of Automated Cell Culture Analysis Upper Limit Lower Limit

28 Benefits of Automated Cell Culture Analysis

29 1. Introduction 2. Cell maintenance / Single Cell Cloning 3. QbD approach 4. Measurement technology 5. Bioprocess automation 6. Summary

30 Summary Automated High Throughput Cloning Process High flexibility of experiments using multiple application robot and imaging technology Meets all steps of cloning process: From limited dilution to clone detection and transfer of best perfoming clone to upscale process Evaluation of multiple parameters using combined brightfield and fluorescence imaging Quality by Design Concept Investigates cause effect relationships between CQA and CPP Needs robust, reliable and traceable analyzer technology Supported by high degree of automation for increased process understanding

31 Acknowledgements Roche Diagnostics GmbH, Pharma Biotech Penzberg, Development Fermentation, Germany Roche Diagnostics GmbH, Pharma Biotech Penzberg, Manufacturing Fermentation, Germany Roche Diagnostics GmbH, Pharma Research and Early Development, Cell Sciences, Germany Bayer Technology Services Dr. Stefan Steigmiller, Head of PMT-PAT-Biotech Projects Fraunhofer-Institut für Molekularbiologie und Angewandte Oekologie Dr. Schillberg, Katrin Thees, Yvonne Olbrich

32 Disclaimers & Trademarks For life science research only. Not for use in diagnostic procedures. CEDEX and INNOVATIS are trademarks of Roche. BaychroMAT is a trademark of Bayer Technology Services All other product names and trademarks are the property of their respective owners.

33 We innovate Healthcare

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