Sartorius AG · XETR:SRT
Sartorius — Technical Presentation
29 slides from Sartorius's technical presentation
Slide 1: Sartorius early phase mAb Platform: Process development consultant team introduction
Platzhalter Bild Sartorius early phase mAb Platform Process development consultant team introduction
Slide 2: Agenda
Agenda • Introducing the Process Development Consultant team • mAb Process • From Concept to Final Product Cellca – Cell Line Development Upstream Process BioOutsource – Analytical Testing Harvest Downstream Process Final Fill and FInish • Single Use Portfolio • Process Modeling
Slide 3: Process Development Consultant (PDC): integrated network of experts and services
Process Development Consultant (PDC) : Taking mAb development support to the next level through an integrated network of experts and services Discovery Phase I Phase II Phase III Commercial - Choosing the Right Clone - Perform HTS and scale up of upstream process - Guide and Execute complete list of
Slide 4: A Typical mAb Process
A Typical Mab Process Development of clone and Clone and Product testing Research Cell Bank Product Testing
Slide 5: Technology Platform For Industrial Protein Production
Technology Platform For Industrial Protein Production Cell Line Process Process Development Development Transfer Host Cell line: CHODG44 licensed from Prof Chasin, Media growth in suspension, 18h doubling time, long term System stability, predictability Host cell line Expression Vector: DHFR selecti
Slide 6: The CHOptimizer
“EE sartorius stedim biotech The "CHOptimizer" ¢ Flexible in-house service using the CHOptimizer media optimization package: * modular structure * choice of support level up to full package provided by a world-wide team of media application specialists * choice of supply agreements * module 1: media
Slide 7: Media Screening Diversified Choice
Media Screening Diversified Choice Media for CHO Non-Animal Protein-Free Chemically (GS, DG44, CHO-S, CHO K1) Origin Defined Base Media PowerCHOTM 1 Yes Yes Yes PowerCHOTM 2 Yes Yes Yes PowerCHOTM 3 Yes Yes Yes PowerCHOTM GS Yes Yes Yes ProCHO4TM Yes Yes No ProCHO5TM Yes Yes No V8 (license required)
Slide 8: Upstream Production from Lab to Production
Upstream Production from Lab to Production: A radically novel approach to upstream mAb development ambr UniVessel SU BIOSTAT® RM BIOSTAT® STR 15 up to 250 ml 0.6 up to 2 liters 0.1 up to 300 liters 12.5 up to 2,000 liters
Slide 9: ambr 15 System, ambr 250 System, Univessel SU – Process Knowhow
Process Knowhow (PDC)- Upstream Process Development ambr 15 System Clone screening ambr 250 System Stability, Cell growth Process optimisation Media Screening Process characterisation Platform compatibility Media optimization High-throughput screening, automation, robotics, small scale Univessel SU
Slide 10: Biosafety Testing Services
Biosafety Testing Services Health authorities, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), require all biopharmaceuticals to undergo stringent safety testing. Testing Capabilities Analytical methods (Mainly on BDS) -Bacterial and fungal contaminants -
Slide 11: Cell Harvesting: Finding the perfect solution
Cell Harvesting: Finding the perfect solution Sartoclear Depth Filtration Fully disposable solution Plug and Play Technology Sartoclear Dynamics (Body-Feed Filtration) Replaces the centrifuge and Depth filtration in high cell density processes Enables fast flow rates and does not need pre-flushing P
Slide 12: Centrifuge-free single-use harvesting with Sartoclear Dynamics
Centrifuge-free single-use harvesting becomes a reality with Sartoclear Dynamics page 12
Slide 13: Downstream Process Flow for a Mab Process
Downstream Process Flow for a Mab Process Role of Process Development Consultant • Selection of Appropriate Chromatography Steps • Optimization of steps to achieve maximum purity • Guidance on Regulatory Requirements • Addressing the need for virus clearance by selecting cost effective and scalable
Slide 14: Chromatography for a Mab Process
Chromatography for a Mab Process Process step Products Available Features /Product positioning Polishing Contaminant removal: flow-through Q (AEX) mode to remove DNA, Host cell STIC (AEX) proteins, endotoxins, viruses Single-use HIC 4 mm bed height S (CEX) Purification: bind & elute of virus
Slide 15: Gel versus Membrane when polishing a monoclonal antibody
Gel versus Membrane when polishing of a monoclonal antibody- Decreased Operation Time Q Resin Q Membrane Flux / flow rate 100 – 150 cm/h 450 – 600 cm/h Capacity 50 – 100 g/L > 3 kg/m² or > 10.9 kg/L Buffer used 100 % 5% Operation time 8–9h 2 – 2.5 h Cleaning validation Yes Single use Zhou J X, Tress
Slide 16: Orthogonal Virus Clearance – A Regulatory Requirement
Orthogonal Virus Clearance – A Regulatory Requirement Inactivation Adsorption Size Exclusion UVivatec® Sartobind® Q Membrane Adsober Virosart® CPV/HF Nanofiltration Adsorbs all Viruses Robust Filtration of all Inactivates most Viruses Viruses > 4 logs Adsorption of > 4 logs Inactivation of PPV/MVM >
Slide 17: Ultrafiltration/Diafiltration for a Mab Process
Ultrafiltration/Diafiltration for a Mab Process Process step Products Available Features /Product positioning • Crosslinked Regenerated Cellulose • > 95% Recovery UF/DF Re-usable • Low Protein Binding • Easy Cleanability • 1N NaOH stable Hydrosart • Pre flushed and sterilized disposable units UF/DF
Slide 18: Sartoflow Crossflow Equipment
Sartoflow Crossflow Equipment Bench, Pilot, and Production Scale UFDF Slice 200 Advanced Alpha Plus Beta Plus SU Production Scale UFDF FlexAct UD Sartoflow Alpha Plus SU
Slide 19: Your Filtration Needs
Your Filtration Needs Broad Spectrum of Filters for both prefiltration and sterile filtration Helping you choose the right filter is the key With small scale filtration trials performed by our state of the art Zero T system Large Scale Small Scale Integrity Tester Sartocheck
Slide 20: Bioburden Control/Sterility Assurance in mAb Manufacturing
Bioburden Control/Sterility Assurance in mAb/Rec. Prot. Manufacturing Sartopore® Filter Platform Harvest, DS Bulk Drug Buffer Prep Media Prep Intermediates Substance Sartopore 2 (HF) Sartopore 2 XL* Sartopore 2 XLG Sartopore Platinum Highly High flow rate High capacity 0.2 High hydrophilic o
Slide 21: Bringing it all together - Robust Single Use Processing for All Scales
Bringing it all together - Robust Single Use Processing for All Scales
Slide 22: Fast process development through scalable, single-use solutions
Fast process development and process set up through scalable, single-use solutions Products in Market : • High throughput bench scale devices • SU Solutions at bench, pilot, and production scale • Scalable devices
Slide 23: UPSTREAM Single-Use Portfolio
UPSTREAM Single-Use Portfolio Media Filtration Aseptic Transfer Cell Culture Preparation and Storage Flexel® Magnetic - sterilizable filters Biosafe®-RAFT Port Biostat® Single-Use Mixing Systems Flexel® 3D-bags Transfer-Sets Cultibag STR Sensors pH, DO, T Palletanks Harvest Filtration and Storage
Slide 24: DOWNSTREAM Single-Use Portfolio
DOWNSTREAM Single-Use Portfolio Diafiltration Aseptic Transfer Filtration Polishing Concentration and Storage and Storage Sartoflow® Biosafe®-RAFT Port Flexboy® bag with Sartobind® Alpha plus-SU Transfer-Sets - sterilizable filters Membrane chromatography Virus Inactivation Storage Virus Filtratio
Slide 25: SSB Overview – Sterile Connections / Disconnections
Enabling Singe Use SSB Overview – Sterile Connections / Disconnections Opta ® SFT Connector BioWelder® BioWelder® TC Mechanical connection Thermal connection Thermal connection Si(Pt) tubing, TPE tubing TPE tubing Liquid filled TPE tubing others tubings (if qualified) Sterile connections Sterile Dis
Slide 26: From Reusable to Single-use Technologies: How to get to a meaningful assessment?
From Reusable to Single-use Technologies: How to get to a meaningful assessment? 26
Slide 27: BioSolve Process Configurable Process Model
BioSolve Process Configurable Process Model - Process Modelling provided by teh Process development consultant team Process Definition MAb Typical Rapid process configuration Product Titre 5.00 g/L Capacity Utilisation 80% Rapid option evaluation Production Bioreactor Volume 5000 L Technologies Sing
Slide 28: Process Development through Commercial Scale BioProcess Solutions
Process Development through Commercial Scale BioProcess Solutions – We are there every Step of the Way Fully scalable, robust, single-use upstream portfolio (250ml-2000L). Downstream single use solutions for all processing scales. FlexSafe PE film for robust, consistent, single use processing. Proce
Slide 29: Complete Product Portfolio for Single-Use mAb Process Development
Complete Product Portfolio to Allow for Single-Use mAb Process Development