BIOSTAT RM - Rocking Motion Bioreactors

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1 BIOSTAT RM - Rocking Motion Bioreactors Single-Use Solutions for Screening, Seed & Small Scale Production Dr. Franziska Faulstich, Product Manager Single-Use Bioreactors, Fermentation Technologies

Content 1 2 3 4 5 6 6 Product Family BIOSTAT RM From Basic to Advanced

2 Content Product Family BIOSTAT RM From Basic to Advanced Applications BIOSTAT B with RM 20/50 BIOSTAT B with RM 200 Flexsafe RM Ordering Page 2

3 Wave Induced Motion Principle: Wave Induced Motion No gas permeable membranes for oxygen transfer Oxygen transfer and mixing are accomplished by the principle of wave-induced motion (WIM) Bubble free overlay aeration Low shear stress

4 Single Use Upstream Solution Sartorius bioreactor product overview market leader in fermentation BIOSTAT B with RM 20/50 Rocker BIOSTAT B with RM 200 Rocker BIOSTAT RM 20/50 L BIOSTAT STR L BIOSTAT RM 200 ambr ml Univessel SU 2 Small Scale Benchtop Pilot/Production

5 Product Family: BIOSTAT RM 200 L (100 L) BIOSTAT B with RM 200 Rocker 50 L (25 L) 100 L (50 L) 2 L (1 L) 1 L (0.5 L) 20 L (10 L) 10 L (5 L) BIOSTAT RM 20/50 Basic BIOSTAT B with RM 20/50 Rocker

6 BIOSTAT RM BIOSTAT RM 20/50 - from Basic to Advanced BIOSTAT RM 20/50 Basic Cell culture without need for sophisticated control Cost effective and fast seed production Alternative to roller bottle, spinner flask or T-flask BIOSTAT RM 20/50 with BIOSTAT B control tower Fully automated and controlled batch, fed-batch or high cell density perfusion cultures Use of Flexsafe RM bags with single-use ph, DO and biomass sensors Highest cell densities/product yields with ease of use

7 BIOSTAT RM BIOSTAT RM 20/50 basic - Easy to Use Rocker Working volume 100 ml to 25 L Rocking rate: 8 42 ± 1 r/min Rocking angle: 4-10 ± 0,3 Perfectly sized, stand alone bioreactor unique in the market Based on well proven principle No internal mixing or sparger device Cells Mammalian cell culture Insect cell culture Low to medium density microbial cultures Shear sensitive cells such as stem cells

8 BIOSTAT RM Load cells the weighing solution Weight measurement integrated in Rocker Monitoring the fill level of bag precisely even during rocking Space saving load cell module

9 Load Cells Rocker integrated load cells for media weight and level control Load cells in rocker determine media weight and drive feed pump Harvest with manual control (optional GFC) Advantages Consumes less space Cost efficient, only load cells required Keeps media in bag constant very precise measurement with load cells even when rocking

10 Process Options Cell culture process options of Biostat RM systems Fully automated and controlled batch or fed-batch processes High cell density perfusion process using external cell retention unit

11 Cell types Which cells can be cultivated with the BIOSTAT RM systems? Mammalian, insect and plant cell culture Low to medium density microbial cultures Shear sensitive cells such as stem cells

BIOSTAT RM BIOSTAT RM 20/50 Basic Features filter heater plugged

lid design with space for filter heater tube and cable organizer

operation load cells colour touch screen with Trend & Alarm

DP interface guaranteed to work with DeltaV optional gassing

12 BIOSTAT RM BIOSTAT RM 20/50 Basic Features filter heater plugged directly in rocker base individual control of 2 bags (T, gasfl) lid design with space for filter heater tube and cable organizer automatic sample function colour coded plugs and socket for easy operation load cells colour touch screen with Trend & Alarm Display standard Ethernet & Modbus RTU interface optional ProfiBus DP interface guaranteed to work with DeltaV optional gassing module with integrated Air/CO 2 mixing 3 different user levels service interval display

13 BIOSTAT RM Connections for Data Acquisition and Control BIOSTAT RM basic I/O protocol supplied by SSB ETHERNET ProfiBusDB I/O protocol supplied by SSB Modbus RTU RS232 driver supplied by customer e.g. BioPAT MFCS driver supplied by customer RS232 third party data acquisition software

SCADA Software BioPAT MFCS/win SCADA Software for Bioprocess Management Besides the core functionality of a real SCADA system, BioPAT MFCS/win offers a number of additional modules for adaptation to

14 SCADA Software BioPAT MFCS/win SCADA Software for Bioprocess Management Besides the core functionality of a real SCADA system, BioPAT MFCS/win offers a number of additional modules for adaptation to individual requirements Recipe control according to ISA CFR Part 11 compliance Secure integration into company networks Flexible device connection facility via OPC Replication Manager for automatic batch transfer Logging of alarms and transmission to multimedia devices Integrated Design of Experiments (DoE)* Integrated Multivariate Data Analysis (MVDA)* * powered by UMETRICS

15 BIOSTAT RM with BIOSTAT B controller One control platform for all

16 BIOSTAT B Controller with RM Advanced Control System - BIOSTAT B with BIOSTAT RM 20/50 Working volume 100 ml to 25 L Advanced control of gas mixture and flow rate, filling volume and substrate addition Extra small space requirement in TWIN configuration Applications: fully automated and controlled batch culture fed-batch culture high cell density perfusion culture

BIOSTAT B with Rocker BIOSTAT B with Rocker Basic and advanced solutions 4 independent gassing lines with 4 mass flow controllers Perfusion option via connection

17 BIOSTAT B with Rocker BIOSTAT B with Rocker Basic and advanced solutions 4 independent gassing lines with 4 mass flow controllers Perfusion option via connection to external cell retention device, e.g. ATF (100l & 200l bags with perfusion membrane no longer available) Up to 3 media feeds Up to 2 gravimetric flow controllers

18 BIOSTAT B Controller with RM The BIOSTAT B From June 2014 on with RM Rocker BIOSTAT B with RM Rocker is the successor of BIOSTAT RM Optical and Perfusion

BIOSTAT B BIOSTAT B The Gold Standard of benchtop bioreactors 12 touch screen with flush housing integration for liquid protection Controller, software & culture vessels made in-house Connection to

19 BIOSTAT B BIOSTAT B The Gold Standard of benchtop bioreactors 12 touch screen with flush housing integration for liquid protection Controller, software & culture vessels made in-house Connection to glass and singleuse vessels and Rocker WM 114 Easy load pumps Available in single and twin configurations Various gassing and feeding strategies available Largest installation base worldwide with reference applications for many processes

20 BIOSTAT B One control platform for all* UniVessel UniVessel SU Rocker 20/50 Rocker 200 * depending on tower configuration

21 BIOSTAT B Storage Dish for accessories Lifting Handles for easy transportation 12 touch screen with frameless design for liquid protection

22 BIOSTAT B Sensor Field located at the front WM 114 Easy load pumps

23 BIOSTAT RM with Controller New gassing module old BIOSTAT RM optical vs. BIOSTAT RM with BIOSTAT B Mixture of exclusive flow (air, N2, O2) Additive flow (CO2) with 2 mass flow controllers 4 independent gassing lines with 4 mass flow controllers either with DO cascade control or optional advanced DO controller

24 BIOSTAT RM with Controller New options for media feeds old BIOSTAT RM optical vs. BIOSTAT RM with BIOSTAT B No CTO media feed or GFC No CTO rocker weight measurement No CTO level control Up to 3 media feeds Up to 2 gravimetric flow controllers Load cells integrated in Rocker for media weight and level control 26 May 2014

25 BIOSTAT RM with Controller New solution for perfusion old BIOSTAT RM optical vs. BIOSTAT RM with BIOSTAT B One balance to weigh the feed One balance to weigh the harvest No direct measurement of cell culture volume Load cells in rocker determine media weight and drive feed pump Harvest with manual control (optional GFC) Precise solution, but some disadvantages : Space requirement Price Does not detect media loss due to evaporation Advantages : Consumes less space Cost efficient, only load cells required Keeps media in bag constant Very precise measurement with load cells even when rocking

26 . Features, Advantages & Benefits part 1 Feature Advantage Benefit Rocking Motion Technology Highly flexible bag design Single use sensors Over Pressure Prevention System Integrated Air/CO2 module for basic rocker (option) Gentle and efficient mixing. Well established wave-type technology Longest history in single use bioreactors. Different sizes from 0.1 L to 100 L working volumes, many different connections, with or w/o ph, DO & biomass sensors. ph, DO and biomass sensors integrated in the bag, delivered sterilized and precalibrated. Controller measures bag pressure and keeps it below 30 mbar. Allows to work with fixed percentage of CO2 ( incubator style ). Well known to customers and FDA, large number of references. Allows highest flexibility of processes with low consumable costs. Eliminate risk of contamination, reduce calibration effort. Highest possible safety against overpressure. Risk of bag damage by overpressure is eliminated. Turns rocker into fully functional stand alone unit for simple cultivations.

27 . Features, Advantages & Benefits part 2 Feature Advantage Benefit BIOSTAT B controller Heating and Cooling option Touch screen user interface Individual control (T, gassing) of two bags on one rocker Newest generation of bioreactor control system with full feedback control of all relevant process parameters. Heating cooling by stainless steel coil on bag holder and thermostat unit in control tower. Graphical display for operation and data display. Great flexibility: allows different process conditions simultaneously. Well known to the industry, easy to use, same controller for many different SSB instruments. Precise temperature control even in high ambient temperatures and lower cultivation temperatures. Possibility to run multiphasic processes. Easy to use, helps to avoid errors. Save time and space. Improved filter heater Better heating efficiency, connects directly into rocker. Monitoring connection of filter heater before start of process. Even more efficient prevention of filter blockage. Alarm if user forget to plug in heater. Improved process safety.

28 Features, Advantages & Benefits part 3 Feature Advantage Benefit Modbus RTU and Ethernet port (standard) and Profibus DP (optional) New lid design and cable/tube organizer Allows direct connection to third party software (e.g. historian). I/O protocol supplied by SSB. Space for filter heaters, lid is click-fixed to bag holder. Cables and tubes are neatly organized. Enables integration into facility networks. Prevents bending of exhaust tubes, enhances process safety. Prevents tube spaghetti. Color coded plugs and sockets Connection made easy. Enhanced ease of operation. Electronic angle setting Improved communication between rocker and Tower Angle can be set in Rocker display and Tower. Process values, set points, alarms, controller parameters are transferred in both ways. Include angle in automation strategy. Enhanced flexibility, enhanced process safety.

29 Highlights Advanced Control System - BIOSTAT B with RM Rocker Same well-known BIOSTAT B control tower Configurability of pumps and MFCs Available in single & twin configuration Improved hood design with space for filter heaters Integrated weight measurement with load cells (optional) Material of entire system (incl. lab-cart) optimized for use in clean rooms

rockers with one control tower saves space RM 20/50 only, RM200 twin BAG configuration RM 200 Modular concept

training needed, user friendly Configurability of pumps and MFC Flexsafe Film Industry leading, proprietary S80

30 USPs SSB vs. Competition Key Differentiators / USPs BIOSTAT B - Twin setup we are the only manufacturer who can control two rockers with one control tower saves space RM 20/50 only, RM200 twin BAG configuration RM 200 Modular concept allows space saving arrangement Same well-known Biostat B control tower as for Biostat RM 20/50 - no special training needed, user friendly Configurability of pumps and MFC Flexsafe Film Industry leading, proprietary S80 film Ultimate assurance of supply (Excellent cell growth proven by independent Dechema study) BioPat ViaMass single-use viable biomass sensor Only single-use wave style bags in market with non-invasive viable biomass measurement

31 BIOSTAT B with RM 200 Next Generation of Rocking Motion Single-Use Bioreactor

BIOSTAT RM 200 Applications of BIOSTAT RM 200 system Preclinical and clinical studies - fast protein and cell supply Large scale seed expansion for large

32 BIOSTAT RM 200 Applications of BIOSTAT RM 200 system Preclinical and clinical studies - fast protein and cell supply Large scale seed expansion for large bioreactors, e.g. stirred tank bioreactor Small scale production of monoclonal antibodies, recombinant proteins and vaccines cgmp production Seed process RM 20 RM 200 STR 2000

33 Old vs. New RM 200 BIOSTAT B with RM 200 Rocker OLD NEW modular design for flexible arrangement load cells integrated load cells twin bag option

34 Old vs. new RM 200 New gassing module Mixture of exclusive flow (air, N2, O2) and additive flow (CO2) with 2 mass flow controllers 4 independent gassing lines with 4 mass flow controllers either with DO cascade control or optional advanced DO controller

35 Old vs. new RM 200 New options available Perfusion option via internal membrane for fully automated continuous processes No CTO media feed or gravimetric flow controller option No CTO rocker weight measurement option No CTO level control option Perfusion option via connection to an external cell retention device, e.g. ATF (100l & 200l bags with perfusion membrane no longer available) Up to 3 media feeds Up to 2 gravimetric flow controllers Rocker integrated load cells for media weight and level control

Biostat RM 200 Description of the BIOSTAT RM 200 system Single Bag Configuration The system consists of : BIOSTAT B control tower BIOSTAT RM 200 Rocker Flexsafe RM 100 L or

36 Biostat RM 200 Description of the BIOSTAT RM 200 system Single Bag Configuration The system consists of : BIOSTAT B control tower BIOSTAT RM 200 Rocker Flexsafe RM 100 L or 200 L bag(s) with single use ph & DO sensors Lab-cart Twin Bag Configuration Working volume from 10 L up to 100 L Single Bag or Twin Bag Configuration No basic version of RM 200

37 BIOSTAT RM Rocker BIOSTAT RM 200 Rocker the new generation NEW Corporate design as for BIOSTAT RM 20/50 Integrated load cells (optional) Flexible arrangement Efficient and gentle mixing No high voltage connection required CE-marking, UL/CSA (EN ) Heating or heating/cooling function (optional)

38 New Features Load cells the weighing solution Rocker: integrated weight measurement Precisely monitor fill level of bag even during rocking Space saving Optional load cells

Twin Bag version of the device with two culture bags

39 New Features Large opening for sampling Cable/Tube organizer New hood design with space for filter heater Twin Bag version of the device with two culture bags different temperatures can be set for the two heating elements

40 BIOSTAT B BIOSTAT B control tower the gold standard Proven DCU controller and software Control of glass and single-use vessels and Rockers WM 114 fast load pumps Various gassing and feeding strategies Available in single and twin bag configuration Overpressure control Feedback control of temperature, ph, DO and agitation (rocker speed & angle) Connectable to advanced SCADA software, BioPAT MFCS 4 or BioPAT MFCS/Win incl. OPC module

41 Lab-Cart Flexible arrangement with the lab-cart Robust platform for controller 3 shelves - middle one is adjustable incl. 2 baskets for bottles and cable/tube organizer Flexible use for external pumps, feeding bags Easy to clean developed for clean room use Made of stainless steel

third party data acquisition software third party data acquisition software Communication Communication and Data Acquisition BIOSTAT RM

42 third party data acquisition software third party data acquisition software Communication Communication and Data Acquisition BIOSTAT RM 200 BioPAT MFCS 4 or BioPAT MFCS/win ETHERNET OPC I/O protocol supplied by SSB BioPAT MFCS/win incl. OPC module OPC BioPAT DCU OPC Server.Net

43 Flexsafe RM Disposable Cultivation Bag

44 Flexsafe RM bags Flexsafe RM bioprocessing bags of Flexsafe Bag Family Excellent Cell Growth Robustness Consistent Quality S80 FILM Multilayer film structure The new benchmark PE film represents optimal combination of cell culture performance and physico-chemical properties Flexsafe meets the most stringent customer needs for safer bioprocessing

200 L Working volume: 50% of total volume TUBING MATERIAL C-Flex 374 all tubes weldable

45 Flexsafe RM bags BAG DESIGN Basic bags Optical bags with single-use ph, DO and viable biomass sensors Perfusion bags BAG SIZES Total volume: 1 L, 2 L, 10 L, 20 L, 50 L, 100 L, 200 L Working volume: 50% of total volume TUBING MATERIAL C-Flex 374 all tubes weldable Silicone PharMed Natvar ABL-1222 TPE PORTS Harvesting Sampling Probes Addition Surface aeration

46 Main Competitors Film Overview Product SSB Flexsafe RM GE Cellbag Meissner FlexGro Film Flexsafe Bioclear 11 TepoFlex Working Volume Up to 100L Up to 100L Up to 25L Online Biomass Measurement Yes No No Raw material supplier agreements: change notification agreement with film supplier 10-year contract with film manufacturer Safety stocks of resin & films for up to 2 years supply Multiple bag mfg & sterillization sites Specifications for resins and additives Yes Yes Yes Yes Access to formulation Control of resin formulation Access to polymer and additives by CAS number June 2016 Page 6 Yes No No? commercially available LLDPE resins No No No No Guarantee forward and backward traceability of every component in biocontainer assembly Full Control of Extrusion Process Yes No No Cell Growth Data Tested with 9 different cell lines 1 cell line (CHO DG44) No EtOH extraction Pure EtOH 20% EtOH 96% EtOH 112 days, 40 C 28 days at 50 C 90 days, 40 C

47 Ordering information How to order the BIOSTAT RM system? Quotations are available via your local application specialist and sales representative. Each quote is generated via our Product Configurator software program for fast turn-around, Sartorius will help you identifying your requirements.

48 Ordering information How to order Flexsafe RM bags? Article Number Product Description Flexsafe RM qty per order code min. order quantity min. order quantity Article Number Product Description Flexsafe RM Flexsafe RM Basic bags per box bags box Flexsafe RM Perfusion bags per box bags box DFB001L Flexsafe RM 1L basic (5 pcs) DFP002L--SM Flexsafe RM 2L perfusion pro 1,2 µm (3 pcs) DFB002L Flexsafe RM 2L basic (5 pcs) DFP010L--SM Flexsafe RM 10L perfusion pro 1,2 µm (3 pcs) DFB002L----01SC Flexsafe RM 2L basic SC (5 pcs) DFP020L--SM Flexsafe RM 20L perfusion pro 1,2 µm (3 pcs) DFB010L Flexsafe RM 10L basic (5 pcs) DFP050L--SM Flexsafe RM 50L perfusion pro 1,2 µm (3 pcs) DFB010L----01SC Flexsafe RM 10L basic SC (5 pcs) DFP002L--AT Flexsafe RM 2L perfusion ATF (3 pcs) DFB020L Flexsafe RM 20L basic (5 pcs) DFP010L--AT Flexsafe RM 10L perfusion ATF (3 pcs) DFB020L----01SC Flexsafe RM 20L basic SC (5 pcs) DFP020L--AT Flexsafe RM 20L perfusion ATF (3 pcs) DFB050L Flexsafe RM 50L basic (5 pcs) DFP050L--AT Flexsafe RM 50L perfusion ATF (3 pcs) DFB050L----01SC Flexsafe RM 50L basic screw cap (5 pcs) DFP100L--AT Flexsafe RM 100L perfusion ATF (2 pcs) DFB050L----01US Flexsafe RM 50L basic GE rocker (5 pcs) DFP200L--AT Flexsafe RM 200L perfusion ATF (2 pcs) DFB100L Flexsafe RM 100L basic (2 pcs) Flexsafe RM ViaMass DFB200L Flexsafe RM 200L basic (2 pcs) DFB010L----VM Flexsafe RM 10L basic Viamass (5 pcs) Flexsafe RM Optical DFB020L----VM Flexsafe RM 20L basic Viamass (5 pcs) DFO002L Flexsafe RM 2L optical (5 pcs) DFB050L----VM Flexsafe RM 50L basic Viamass (5 pcs) DFO002L----01SC Flexsafe RM 2L optical SC (5 pcs) DFO010L----VM Flexsafe RM 10L optical Viamass (5 pcs) DFO010L Flexsafe RM 10L optical (5 pcs) DFO020L----VM Flexsafe RM 20L optical Viamass (5 pcs) DFO010L----01SC Flexsafe RM 10L optical SC (5 pcs) DFO050L----VM Flexsafe RM 50L optical Viamass (5 pcs) DFO020L Flexsafe RM 20L optical (5 pcs) DFO100L----VM Flexsafe RM 100L opt ViaMass (2 pcs) DFO020L----01SC Flexsafe RM 20L optical SC (5 pcs) DFO200L----VM Flexsafe RM 200L opt ViaMass (2 pcs) DFO050L Flexsafe RM 50L optical (5 pcs) DFP010L--SMVM Flexsafe RM 10L perfusion Viamass (3 pcs) DFO050L----01SC Flexsafe RM 50L optical SC (5 pcs) DFP020L--SMVM Flexsafe RM 20L perfusion Viamass (3 pcs) DFO100L Flexsafe RM 100L optical (2 pcs) DFP050L--SMVM Flexsafe RM 50L perfusion Viamass (3 pcs) DFO200L Flexsafe RM 200L optical (2 pcs) DFP010L--ATVM Flexsafe RM 10L ATF Viamass (3 pcs) Customized design DFP020L--ATVM Flexsafe RM 20L ATF Viamass (3 pcs) DFCnnn (customer specific) Flexsafe RM customized 10 DFP050L--ATVM Flexsafe RM 50L ATF Viamass (3 pcs) DFP100L--ATVM Flexsafe RM 100L ATF ViaMass (2 pcs) qty per order code min. order quantity min. order quantity DFP200L--ATVM Flexsafe RM 200L ATF ViaMass (2 pcs) 2 4 2

49 BioPAT ViaMass single-use biomass sensor for non-invasive measurement of viable biomass Art. No Description DFB010L----VM Flexsafe RM 10L basic ViaMass (5 pcs) DFB020L----VM Flexsafe RM 20L basic ViaMass (5 pcs) DFB050L----VM Flexsafe RM 50L basic ViaMass (5 pcs) DFO010L----VM Flexsafe RM 10L optical ViaMass (5 pcs) DFO020L----VM Flexsafe RM 20L optical ViaMass (5 pcs) DFO050L----VM Flexsafe RM 50L optical ViaMass (5 pcs) DFO100L----VM Flexsafe RM 100L optical ViaMass (2 pcs) DFO200L----VM Flexsafe RM 200L optical ViaMass (2 pcs) DFP010L--SMVM Flexsafe RM 10L perf ViaMass (3 pcs) DFP020L--SMVM Flexsafe RM 20L perf ViaMass (3 pcs) DFP050L--SMVM Flexsafe RM 50L perf ViaMass (3 pcs) DFP010L--ATVM Flexsafe RM 10L ATF ViaMass (3 pcs) DFP020L--ATVM Flexsafe RM 20L ATF ViaMass (3 pcs) DFP050L--ATVM Flexsafe RM 50L ATF ViaMass (3 pcs) DFP100L--ATVM Flexsafe RM 100L ATF ViaMass (2 pcs) DFP200L--ATVM Flexsafe RM 200L ATF ViaMass (2 pcs) 22 June 2016 Page 2

50 Additional Information 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 45

51 Thank you very much for your attention! turning science into solutions Page 48

BIOSTAT RM Culturing Convenience

BIOSTAT RM Culturing Convenience Culturing Convenience The BIOSTAT RM is the new generation of single-use bioreactors utilizing rocking motion for mixing with low shear. In 2011, Sartorius Stedim Biotech