Internal Presentation. BIOSTAT Cplus. The SIP Stainless Steel Fermenter Bioreactor for Your Lab

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Harry Fletcher
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1 Internal Presentation BIOSTAT Cplus The SIP Stainless Steel Fermenter Bioreactor for Your Lab

2 Changes Main Changes New BIOSTAT Cplus Product Changes - DFC controller replaced by DCU control platform - up to 4 MFC for Additive Flow gassing strategy with up to 4 integrated pumps - VP sensor connectors for ph and DO - Optical DO sensor (Visiferm) available - M12 connectors for external inputs, external feed pump connection etc. - Substrate software controller not part of standard software function - Software feature unused integrated pump can be configured as substrate pump not available - Gas Flow Ration software controller not available -> configure Advanced DO controller instead - More software features: Advanced DO Controller, Culture Vessel Pressure Hold Sequence and Gravimetric Feed Control available as option

3 Changes Main Changes New BIOSTAT Cplus Product Changes Discontinued: 2L working volume culture vessel Exclusive Flow gassing strategy Bubble-free aeration

4 Changes Main Changes New BIOSTAT Cplus Configurator Changes - Configurator structure harmonized with BIOSTAT B and D-DCU - Customer get what is configured in the configurator e.g. Substrate controller no longer part of standard software scope - Steam and condensate tubing's are not listed as separate item in the quote -> Now included under Sterilization e.g. manual sterilization sampling valve - Only one MO entry, selection in the po2 control Gassing strategy -> O2-Enrichment or Gasflow Ratio - New entry Dual Use. Additive Flow gassing strategy with free configurable gassing rates and vessel accessories - Qualification now in the configurator New Basic Configurations (BC) not include sampling valve, high foam kit, casters, tray for storage bottles, motor holder and foam measurement and control

5 Contents A Profile of Sartorius Bioprocess Solutions Division BIOSTAT Cplus Competition Overview Page 2

6 A Profile of Sartorius Sartorius Runs Three Divisions Sartorius Group Bioprocess Solutions Lab Products & Services Industrial Weighing

7 A Profile of Sartorius Global Presence Sales Production Page 7

8 Contents A Profile of Sartorius Bioprocess Solutions Division BIOSTAT Cplus Competition Overview Page 9

9 Bioprocess Solutions Our Portfolio Filtration Fluid Management Fermentation Purification Integrated Solutions Service Page 10

10 Bioprocess Solutions The Widest Product Portfolio Along Biopharma s Process Chain

11 Bioprocess Solutions Leading Worldwide Market Positions Filtration amongtop 3 Fluid Management #1 Fermentation #1

12 Bioprocess Solutions Our Solutions for Your Process in Upstream Processing (fermentation, cell cultivation, media and buffer preparation)

13 Bioprocess Solutions Our Solutions for Your Process in Downstream Processing (depth filtration, crossflow filtration, virus filtration, freeze & thaw)

14 Bioprocess Solutions Our Solutions for Your Process in Engineering

15 Contents A Profile of Sartorius Bioprocess Solutions Division BIOSTAT Cplus Competition Overview Page 20

16 Introduction BIOSTAT Cplus - SIP stainless steel fermenter bioreactor Fits in your lab Economic integration in existing infrastructure. Choice of steam or electrical heating for operation and culture vessel sterilization Advanced process control and intuitive operation DCU control platform for Advanced DO Control, Gravimetric feeding and touch screen operation Compact and movable Minimum lab space requirement and casters for easy relocation Excellent safety Automatic sequences for culture vessel sterilization and pressure hold test and a maintenance free agitation motor

The BIOSTAT C Family Tree 1992-2008 2008-08/2013 from August 2013 BIOSTAT C BIOSTAT Cplus New

processes - Very experienced service and application specialists for local support - Trainings

17 The BIOSTAT C Family Tree /2013 from August 2013 BIOSTAT C BIOSTAT Cplus New BIOSTAT Cplus - Largest installation base worldwide with reference applications for many processes - Very experienced service and application specialists for local support - Trainings and seminars for cell culture and fermentation - NEW with DCU control platform and new additional features

Product feature BIOSTAT Cplus New BIOSTAT Cplus Operation/ Display 10 Touch screen 10 Touch screen Integrated amplifiers max.

Flow, Additive Flow Integrated MO: O2-Enrichment, Gasflow Ratio CC: Additive Flow Mass Flow Controller - max.

.. Vessel design Integrated: up 4 (ACID, BASE, FOAM, LEVEL) 2 external substrate pumps System qualification yes yes Gravimetric Feed Control Via BioPAT MFCS/win only

18 Product feature BIOSTAT Cplus New BIOSTAT Cplus Operation/ Display 10 Touch screen 10 Touch screen Integrated amplifiers max. 7 Up to 12 Interface for optical DO sensor No Yes Sensor connectors ph DO DIN Lemo V8 V8 Gassing system Integrated, MO: O2-Enrichment, Gasflow Ratio CC: Exclusive Flow, Additive Flow Integrated MO: O2-Enrichment, Gasflow Ratio CC: Additive Flow Mass Flow Controller - max. 2 MFC (dedicated position) - Up to 4 MFC per Vessel (freely selectable) Pumps BIOSTAT Cplus BIOSTAT Cplus vs. NEW BIOSTAT Cplus at a glance... Vessel design Integrated: up 4 (ACID, BASE, FOAM, LEVEL) 2 external substrate pumps System qualification yes yes Gravimetric Feed Control Via BioPAT MFCS/win only Up to 2 Culture vessel pressure hold sequence No Integrated: up to 4, Total: up to 6 4 x digital (ACID, BASE, FOAM, LEVEL) or 2 x digital + 2 x analogue (Feed) and 2 external substrate pumps (shared output w/ internal pumps) 5L 30 L (2L discontinued) Yes (Option) Advanced po2 Control No Yes (Option)

19 Exhaust filter Supply unit Agitation motor High foam sensor Motor holder Fluid buffer system for double mechanical seal 25 mm port for resterilizabale addition valve Temperature control system Choice of electrical or steam heating Intuitive Touch Screen Control unit Gassing system Up to 4 integrated pump Culture vessel Resterilizable sampling valve Removable bottle tray Sampling bottle Resterilizable bottom seat valve Casters

20 Accessories for easy handling Lift lifting crane Motor holder Casters

21 Overview Measurement and Control capabilities Measurement Control Comments Agitation speed X X Maintenance free, low noise Temperature X X Closed loop pressurized water system Choice of electrical or steam heating ph X X Controlled via CO2/ Acid + Base po2 X X MO: Controlled via agitation speed; O2 supplementation; Aeration rate; Substrate CC: Controlled via O2/ N2 supplementation, agitation speed, Aeration rate, Substrate Foam Level X X For Foam or Level control; user selection High-Foam O O Safety shut down of aeration and agitation Substrate A & B feeding - O Control of internal unused or additional optional peristaltic pump (internal or external) 3 x External Signal X - For integration of external device, i.e.biopat Xgas Pressure O O Manual or automatic Redox and Turbidity O - MFC O O Free selectable Vessel weight O O Gravimetric feed control O O Weight indication of feeding bottle

22 DCU control software Process time Process time Process parameter Weight measurement & Gravimetric Feed control Pumps Main menus Shut down & Status

23 DO Control CASCADE (standard) 4 stage, freely configurable Setting of min. / max. for each cascade PID parameters freely adjustable Next cascade is activated once prior one has reached its max. e.g. C1: Nitrogen Flow C2: Air Flow C3: O2 Flow C4: Stirrer Speed

24 Advanced DO Control (option) Parallel activation of multiple controllers Max. flexibility for advanced process development Based on DO controller output up to five parameters can be activated at the same time e.g. Increase O2 flow & decrease AIR flow while total flow is kept constant Increase flow rate & stirrer speed at the same time

Culture vessel pressure hold sequence (option) Automatic pressure hold test for the culture vessel Adjustable time, test and process pressure

25 Culture vessel pressure hold sequence (option) Automatic pressure hold test for the culture vessel Adjustable time, test and process pressure Monitoring of the pressure characteristics on the Trend display or SCADA system Requires pressure measurement and automatic pressure control valve

26 Control unit Gassing system O2-Enrichment O2-Enrichment Air flow gassing system with O2 Supplementation capability via 3/2-way solenoid valve Rotameter for Total Sparger flow O2 Supplementation automatically controlled via po2 controller Optional Mass Flow Controller for Total Sparger Flow

27 Control unit Gassing system Gas Flow Ratio Gas Flow Ratio - Air flow gassing system with O2 Supplementation capability via mass flow controller for Air and O2 - Rotameter for Total Sparger flow - O2 Supplementation automatically controlled via po2 controller

28 Control unit Gassing System Additive Flow Additive Flow - 4-Gasmixing system gasmixing of Air, N2, O2 and CO2 - Individual Rotameter - Overlay flow and Sparger aeration Overlay: Air only Sparger: Air, O2, N2 and CO2 automatically controlled via ph/ po2 controller - up to 4 optional Mass Flow Controller for

29 Agitation motor Agitation motor Brushless DC Servomotor Gear and maintenance free Motor performance : 2L & 5L 500 W rpm : 10 & 15L 800 W rpm : 20 & 30 L 1200 W rpm

30 Supply Unit Supply Unit 2L & 5L, Benchtop Open frame design with... Frame for culture vessel Console for control unit Thermostat system : Closed-loop pressurized water system with circulation pump and heat exchanger for cooling : Heating Alternatively via stainless steel heat exchanger (cupper soldered) or electrical heating cartridge Temperature control range : 8 C above cooling water up to 90 C Sterilization temperature : up to 130 C

31 Supply Unit Supply Unit 10-30L, Floor standing Open frame design with... Frame for culture vessel Console for control unit Thermostat system : Closed-loop pressurized water system with circulation pump and heat exchanger for cooling : Heating Alternatively via stainless steel heat exchanger (cupper soldered) or electrical heating cartridge : Optional Stainless steel heat exchanger (stainless steel welded) for use with clean steam Temperature control range : 8 C above cooling water up to 90 C Sterilization temperature : up to 130 C

Supply unit accessories - Storage bottle support (Floor stand version only) - Storage bottles 500 ml or 1000 ml - Motor holder - Installation kit - NTP connection kit -

32 Supply unit accessories - Storage bottle support (Floor stand version only) - Storage bottles 500 ml or 1000 ml - Motor holder - Installation kit - NTP connection kit - Casters (Floor stand version only) - Recirculation cooler FRIGOMIX 2000 (230 VAC only) and installation kit - Top plate lifting device (manual operated) (Floor stand version only)

Culture vessel Culture vessel 5L - Vessel with top agitation - Working volume 5L - Aspect ratio H : D (total): 2:1 - Jacketed stainless steel vessel with torospherical bottom and upper glass cylinder

33 Culture vessel Culture vessel 5L - Vessel with top agitation - Working volume 5L - Aspect ratio H : D (total): 2:1 - Jacketed stainless steel vessel with torospherical bottom and upper glass cylinder - Vessel fabrication: PED - Material : Product side: stainless steel (AISI 316L), EPDM, borosilicate glass others: (AISI 304) : Surface: internal: Ra <= 0,5, electropolished external: glass beads blasted, electropolished

Culture vessel Culture vessel 10L - 30 L - Vessel with top agitation - Working volume 10, 15, 20, 30 L - Aspect ratio H : D (total): 2:1 or 3:1 - Jacketed stainless steel vessel with torospherical

34 Culture vessel Culture vessel 10L - 30 L - Vessel with top agitation - Working volume 10, 15, 20, 30 L - Aspect ratio H : D (total): 2:1 or 3:1 - Jacketed stainless steel vessel with torospherical bottom - Longitudinal viewing window - Vessel fabrication: PED or ASME - Material : Product side: stainless steel (AISI 316L), EPDM, borosilicate glass others: (AISI 304) : Surface: internal: Ra <= 0,5, electropolished external: glass beads blasted, electropolished

35 Culture vessel Volume overview Vessel description Working Volume [L] ,5 10 3,5-10 5, ,5 20 5, Total Volume [L]

36 Culture vessel Port overview Description Vessel Top plate port (fixed installations) 5 L 10 L 2:1 3:1 15 L 20 L 30 L Sparger inlet, Exhaust cooler, agitation, sight glass for illumination (10-30 L), safety valve (PED vessel only) Top plate ports 19 mm Upper side ports (25 mm port) ASME vessel addition port for bursting disc Lower side ports (25 mm port) incl. 1 x 12 mm port for Pt Bottom

37 Culture vessel equipment 4 x baffle, removable Exhaust cooler Light glass Ø 25 mm in lid, with removable lamp (10l 30 L only) Safety valve, ASME vessel with bursting disc Temperature sensor Pt 100 Combined harvesting/sampling valve

38 Culture vessel accessories Agitation shaft sealing Single mechanical seal Lubricated by condensate/aerosol in head space Sealing material: ceramic/carbon Double mechanical seal Lubricated by pressurized condensate Sealing material: ceramic/carbon Condensate vessel with viewing window High containment class

Vessel accessories: Impeller for microbial application 6-blade disk impeller The 6-blade disk impeller produces a flow which moves radially away from the shaft and has a high energy dissipation

39 Vessel accessories: Impeller for microbial application 6-blade disk impeller The 6-blade disk impeller produces a flow which moves radially away from the shaft and has a high energy dissipation density. This impeller breaks up air bubbles effectively and thereby improves oxygen transport in the liquid phase. At the same time, high local shear forces are also generated which can have a negative influence on the growth of shear-stress-sensitive organisms (cell cultures, filament-producing fungi).

40 Vessel accessories: Impeller for cell culture application 3-blade segment impeller 3-blade segment impellers are specifically designed for use in culturing of cells sensitive to shear stresses and especially for cell cultures immobilized in suspension or on microcarriers. The impeller creates an axial direction of flow and thereby achieves homogenous and thorough mixing of the culture medium while minimizing shearing forces. 3-blade segment impeller

port Ring sparger μ-sparger Cell culture applications Micro

41 Vessel accessories: Aeration devices direct aeration Microbial applications Ring sparger for 19 mm top plate port Ring sparger μ-sparger Cell culture applications Micro sparger for 19 mm top plate port Sintered stainless steel frit 20 μm

42 Sensors & Connections DO Sensor Hamilton (standard) or Mettler (optional) Clark or Optical electrode ph Sensor Hamilton (standard) or Mettler (optional) Foam & Level sensor Conductive probes Temperature sensor Pt100 sensor with sleeve Page 51

43 Sensors & Connections Redox sensor Combined ph & Redox sensor Hamilton (standard) or Mettler (optional) Turbidity (cell density) sensor On-line measurement of cell growth and biomass Reduction of sampling frequency and bench analyses Absorption based Page 52

44 Vessel accessories: Addition devices Needle assembly for 19 mm port Product description For installation 19 mm top plate port Available as : 1-Channel assembly with 4 x 1 mm needle for tubing 1.6 x 1.6 mm with sterile sleeve : 1-Channel assembly with 6 x 0.5 mm needle for tubing 3.2 x 1.6 mm with sterile sleeve : 3-Channel assembly with 8 x 1 mm needle for tubing 1.6 x 1.6 mm with sterile sleeve Operation: 1. Sterilization in an autoclave together with the addition bottles 2. Sterilization of the culture vessel with septum/ blind plug assembly 3. Remove septum bind plug and tne sterile sleeve of the needle and pierce the septum with the needle

45 Vessel accessories: Addition devices Sacova valve closed Sacova valve open Safety Containment Valve (Sacova) Product description Sterile valve for a 19 mm top plate port 1-Channel or 3-Channel assembly available For tubing 3,2 x 1,6 mm High containment class Operation: 1. Sterilization in an autoclave together with the addition bottle or connected C-flex tubing using a BioWelder for sterile connection 2. After autoclaving installation in the culture vessel and sterilization together with the culture vessel

Vessel accessories: Addition devices Steam line APC 19 autoclave valve assembly Condensate line APC 25 autoclave valve assembly Steam line Condensate Line

tubing 3,2 x 1,6 mm High containment class Operation: 1. APC19 & APC25 are installed in culture vessel 2. Sterlization together with culture vessel 3.

46 Vessel accessories: Addition devices Steam line APC 19 autoclave valve assembly Condensate line APC 25 autoclave valve assembly Steam line Condensate Line Resterilizable Addition Valve (AP19 & APC25) Product description Resterilizable valve for 19 or 25 mm port For multiple sterile connections during the process For tubing 3,2 x 1,6 mm High containment class Operation: 1. APC19 & APC25 are installed in culture vessel 2. Sterlization together with culture vessel 3. Sterilization by autoclave of addition bottles with valve assembly 4. After autoclaving connection of valve assembly to culture vessel and sterlization by steaming of connection line

Vessel accessories: Sampling Steam line Sampling valve SVC 25 Condensate line Sampling bottle with valve assembly (optional) Resterilizable Sampling Valve (SVC 25) Product description

47 Vessel accessories: Sampling Steam line Sampling valve SVC 25 Condensate line Sampling bottle with valve assembly (optional) Resterilizable Sampling Valve (SVC 25) Product description Resterilizable sampling valve 25 mm port For multiple sterile samplings during the process Incl. Sterile sleeve Optional: Sampling bottle with valve assembly Stainless steel kill tank for contaminated condensate

48 Vessel accessories: Sampling Schematic overview SVC 25 with kill tank

Vessel accessories Perfusion via Spinfilter The perfusion system with internal spin filter is needed for the continuous medium exchange at long-term cultivation.

49 Vessel accessories Perfusion via Spinfilter The perfusion system with internal spin filter is needed for the continuous medium exchange at long-term cultivation. Internal Spinfilter are mounted on the agiation shaft. Our recommendation for mesh sizes are as follow: Mesh size 20 μm: Suspension cells Mesh size 40 μm: aggregate-forming cells Mesh size 75 μm: Micro carrier cultivations

50 Vessel accessories: Perfusion via Spinfilter Schematic Drawing of a Cell Culture Bioreactor for Perfusion of Medium

51 Vessel accessories: Miscellaneous - Vessel pressure gauge; -1/+3 bar - Empty vessel sterilization - Blind plug for 19 mm Blind plug 25 mm port - Kill tank - Sampling bottle for SVC 25 - Autoclavable storage bottles L

SCADA Software BioPAT MFCS win SCADA Software Besides the core functionality of a real SCADA system BioPAT MFCS/win offers a number of additional modules for adaptation to individual requirements: -

52 SCADA Software BioPAT MFCS win SCADA Software Besides the core functionality of a real SCADA system BioPAT MFCS/win offers a number of additional modules for adaptation to individual requirements: - Bioprocess optimization with Design of Experiments module (DoE) S88 recipe control Batch control compliant with ANSI ISA CFR, Part 11 compatibility Secure integration into company networks Flexible device connection facility through OPC Expanded data logging and data archiving Logging of alarms and transmission to multimedia devices Page 37

Service Our Services Installation FAT & SAT IQ OQ support & documentation Calibration services Spare part sales Preventive maintenance contracts

53 Service Our Services Installation FAT & SAT IQ OQ support & documentation Calibration services Spare part sales Preventive maintenance contracts Customer-specific maintenance contracts Instrument repairs Technical & application support Practical & technical operator training Page 61

Values Value Products for Value Customers Sartorius bioreactors are built to last for a decade (& more) -> You will enjoy many years of high performance We set high standards to sell excellent -

54 Values Value Products for Value Customers Sartorius bioreactors are built to last for a decade (& more) -> You will enjoy many years of high performance We set high standards to sell excellent - quality products -> You will receive only quality and innovative technologies with your Sartorius product We are represented worldwide -> You ll always have a Sartorius contact to talk to directly in your country Application Specialists > Are available globally to help you with your processes and eliminate any obstacles you encounter

55 Contents A Profile of Sartorius Bioprocess Solutions Division BIOSTAT Cplus Competition Overview Page 20

56 Competition overview Price Techfors-S BioBench BioFlo 510 BIOSTAT Cplus System performance

57 Competition overview BIOSTAT Cplus Applikon BioBench

58 Competition overview Touch screen display Vessel aspect H:D ratio 3:1 and 2:1 (2&5L 2:1 only) Fully jacketed vessel BIOSTAT Cplus Open-frame with integrated Control Tower design Local controller and PC based SCADA system Top driven agitation system Vessel volume WV 2L, 5L, 10L, 15L, 20L, 30L Choice of steam heating or electrical heating operation and sterilization Closed loop pressurized water temp. control system Process control for Agitation speed, Temp., ph, po2; Foam Level; 2 x Substrate feed controller; High Foam: Optional up to 2 MFC, Vessel weight, Pressure Redox (M), Turbidity (M), 2 x feeding bottle weight Open frame supply unit integrated controller design Local controller and PC based SCADA system Touch screen display Top driven agitation system 2:1 only Vessel volume WV 5L, 10L, 20L Central jacket only Applikon BioBench Electrical heating for operation Steam required for vessel sterilization Open loop standard: Closed loop option Process control for agitation speed, Temp., ph, po2, feed controller Optional: Pressure, Vessel weight

59 Competition overview BIOSTAT Cplus Infors Techfors-S

60 Competition overview Local controller and PC based SCADA system Touch screen display Top driven agitation system BIOSTAT C plus Open-frame with integrated Control Tower design Vessel aspect H:D ratio 3:1 and 2:1 (2&5L 2:1 only) Vessel volume WV 2L, 5L, 10L, 15L, 20L, 30L Fully jacketed vessel, 3 upper side ports Closed loop pressurized water temp. control system Choice of steam heating or electrical heating operation and sterilization Process control for Agitation speed, Temp., ph, po2; Foam Level; 2 x Substrate feed controller; High Foam: Optional up to 2 MFC, Vessel weight, Pressure Redox (M), Turbidity (M), 2 x feeding bottle weight Open-frame with integrated Control Tower design PC based integrated control and SCADA software Touch screen display Top driven agitation system 2:1 only Vessel volume WV 5L, 10L, 20L Jacketed vessel, no upper side ports Open loop Infors Techfors-S Electrical heating for operation Steam required for vessel sterilization Process control for Agitation speed, Temp., ph, po2; Optional: Foam Level; Substrate feed controller, Vessel weight, Pressure, MFC

61 Competition overview BIOSTAT Cplus NBS BioFlo 510

62 Competition overview Touch screen display Vessel aspect H:D ratio 3:1 and 2:1 (2&5L 2:1 only) Closed loop pressurized water temp. control system Choice of steam heating or electrical heating operation and sterilization Fully jacketed vessel BIOSTAT C plus Open-frame with integrated Control Tower design Local controller and PC based SCADA system Top driven agitation system Vessel volume WV 2L, 5L, 10L, 15L, 20L, 30L Process control for Agitation speed, Temp., ph, po2; Foam Level; 2 x Substrate feed controller; High Foam: Optional up to 2 MFC, Vessel weight, Pressure, Redox (M), Turbidity (M), 2 x feeding bottle weight Open frame supply unit integrated controller design Local controller and PC based SCADA system Touch screen display Top driven agitation system 2:1 only Vessel volume WV 16L, 32L Open loop standard: Closed loop option Steam required for vessel sterilization and operation full jacket NBS BioFlo 510 Process control for agitation speed, Temp., ph, po2, Gas Flow Control, feed controller, vessel weight Option: Redox, Pressure,

63 Thank You very much for your Attention turning science into solutions Page 64

F2 15/30 SIP PILOT SCALE BIOREACTORS

F2 15/30 SIP PILOT SCALE BIOREACTORS THE COMPANY Bionet is a specialist in bioprocesses engineering. We provide equipment (Bioreactors, Cross-Flow Filtration Systems and Cleaning-In-Place Systems) and