continuous production: is a flow production method used to manufacture, produce, or process materials without interruption.

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1 continuous production: is a flow production method used to manufacture, produce, or process materials without interruption. Wikipedia 26 January 2015 Page 1

2 Continuous Biomanufacturing? 26 January 2015 Page 2

3 What is a continuous biomanufacturing process? 26 January 2015 Page 3

4 What is continuous biomanufacturing about? 26 January 2015 Page 4

5 Equipment, Sensors & Data Analysis? 26 January 2015 Page 5

6 Continuous Biomanufacturing New Developments in Sensors and Automation Marek Hoehse, José Alves-Rausch, Jochen Scholz, Christian Grimm Visit us on booth 503/505

7 Continuous Manufacturing: Potential Advantages Production Improved product quality Profit Higher efficiency Improved scalability Smaller footprint Production of labile products less errors 26 January 2015 Page 7

8 Continuous Manufacturing: Challenges technical New type of in process testing Demanding process requirements More complex DSP approach Raw material concerns process More complex processes Minimizing blackout of operation units Limited number of reliable & scaleable cell retention devices New forms of release approaches (batch definition) 26 January 2015 Page 8

9 Continuous Manufacturing Data Analysis Sensors / Analyzer Equipment Bioprocess 26 January 2015 Page 9

10 Advantages of Single-use Technologies CAPEX reduction Faster production Higher flexibility No crosscontamination Reduced water consumption Reduced energy consumption

11 Is SU ready for continuous manufacturing? Connectivity to cell retention Predictive scale-down model? Media logistics Robust Sensor Technology Long operation times Sufficient CO2 removal High performance clarification? High oxygen demand 26 January 2015 Page 11

12 Continuous modes in culture process upstream? Concentrated fed-batch Perfusion Y sampling and batch release possible steady state analysis online / inline nutrients cells product nutrients cells product 5-20 days days

13 Equipment: BIOSTAT STR: single-use bioreactor 3 blade segment & rushton impeller sufficient mixing and gas exchange Reliable bag production (new FlexSafe film) robustness Optimized for high cell density sufficient O 2 Bioreactor Optical & conventional ph and DO probes (redundant) long time operation 26 January 2015 Page 13

14 Example Perfusion: ATF system allows for relatively high cell densities Cell retention possible cell retention system

15 Example Perfusion: ATF system allows for relatively high cell densities VCD / 10 6 cells/ml Vol / day VCD SPR Process time / days B. Compton et al., Genetic Engineering News October 1, 2007 (vol. 27, nr. 17)

16 Example Perfusion: High cell density inoculum production MCB/WCB vial Perfusion expansion Controlled freeze of HCD seed stocks Direct seed of production bioreactor References: N. C. Bögli et al.: Cell Banking, One-Step Inoculation, and Repeated Fed-Batch Expansion in a Single-Use Bioreactor. BioProcess International 10(5)s May 2012 G. Seth et al.: Development of a new bioprocess scheme using frozen seed train intermediates to inoculate CHO cell culture manufacturing campaigns. Biotech & Bioeng., Volume 110, Issue 5, May 2013, Pages:

17 Sensors & Analyzers: Inline SU Sensors Optical ph and DO Classical Sensors Pressure Flow USP DSP 26 January 2015 Page 17

18 Application Example: ph control in cell culture concentrated Fed-batch ph optical Daily feeding ph classical ph Value (ActiCHO Feed-B: ph 11) ph offline CO2 flow / Lpm process time / days Online optical ph and classical show similar results Stable control of the ph value 26 January 2015 Page 18

19 Sensors & Analyzers: Inline / Online Analytical Systems Online Glc / Lac Inline Biomass NIR Spectrometer Exhaust Gas 26 January 2015 Page 19

20 Automated monitoring and control of continuous processes a reality? Bioreactor (e.g. Biostat RM/STR) Glucose control loop Online Analyzer (BioPAT Trace) Local Control Unit (DCU) Stable glucose control Online monitoring of lactate SCADA BioPAT MFCS + Recipe 26 January 2015 Page 20

21 Automated monitoring and control of continuous processes a reality? 26 January 2015 Page 21

22 Inline Biomass Monitoring 26 January 2015 Page 22

23 Viability [%] Viable Biomass [%] Capacitance [pf/cm] Viable Cell Density [10^5/ml] Viable Cell Diameter [µm] Wet Cell Weight [g/l] Example: Online Biomass Monitoring in CHO Cultivation (RM 50L) Time [days] 26 January 2015 Page 23

24 Viability [%] Viable Biomass [%] Capacitance [pf/cm] Viable Cell Density [10^5/ml] Viable Cell Diameter [µm] Wet Cell Weight [g/l] Example: Online Biomass Monitoring in CHO Cultivation (RM 50L) Time [days] Stable Biomass Monitoring Perfusion mode control possible (Media, Nutrients) 26 January 2015 Page 24

25 Analyzers & Data Analysis: Look into process! Spectroscopy is: Contactless Nondestructive Use inline (NIR) spectroscopy! Fast & Versatile 26 January 2015 Page 25

26 NIR + MVDA: Qualitative Analysis Qualitative: only spectral data! Cell Culture Spectra Data Analysis (PCA) Process Monitoring 26 January 2015 Page 26

27 score detect variations before real deviations NIR + MVDA: Qualitative Process Monitoring contamination low performer (oxygen limitation) process time golden batch process trajectories observe alteration

28 score detect variations before real deviations NIR + MVDA: Qualitative Process Monitoring control chart contamination process time low performer (oxygen limitation) Drill down / root causes analysis: event based process control golden batch process trajectories observe alteration

29 Score 1 MVDA: Continuous Qualitative Process Monitoring (concept) 1 Lag phase 2 primary nutrient consumption metabolite consumption 4-1 Glucose Reference 4 Production phase

30 Score 1 MVDA: Continuous Qualitative Process Monitoring (concept) 1 Lag phase 2 primary nutrient consumption metabolite consumption 4 Production phase Steady state regime: Start online MVDA Start Feed Control (e.g. NIR based)

31 What is continuous biomanufacturing about? Robust Equipment Inline Sensors Online Analytics Process Trajectories Control Parameters 26 January 2015 Page 31

32 Continuous Manufacturing: Single use equipment is ready! Equipment Suitable SU bioreactor Sensors / Analyzers Inline ph and DO control Data Analysis Process Trajectories (also with NIR) Robust SU film material Online Glucose / Lactate Control Steady State Control Ready for high cell density applications Inline biomass monitoring / control Early Fault Detection 26 January 2015 Page 32

33 Thank you! 26 January 2015 Page 33

34 Continuous Biomaufacturing is part of the future! 26 January 2015 Page 34

35 Future starts now! 26 January 2015 Page 35

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