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Made in Germany

bbi-biotech innovation for biotech. Product Presentation Sampling. Made in Germany. bbi-biotech – History overview. The brand belonged to industry leader B.Braun Melsungen and was sold to Sartorius AG in 2000.

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Made in Germany

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  1. bbi-biotech innovation for biotech Product Presentation Sampling Made in Germany

  2. bbi-biotech – History overview • The brand belonged to industry leader B.Braun Melsungen and was sold to Sartorius AG in 2000. • In this time more than 22.000 R&D and numerous production bioreactors had been installed by bbi-biotech worldwide.

  3. bbi-biotech - Network Max-Planck-Society • Strong partner that backs development of sampling technology bioPROBE 300+ Suppliers • Carefully chosen German specialists for every part of a bioreactor 10,000+ Industry Contacts • Network built over 3 decades • From the pharmaceutical and bioprocess industry

  4. xCUBIO bioreactor family One Automation for all Bioprocesses xCUBIO single xCUBIO tissue xCUBIO twin xCUBIO retrofit xCUBIO Automation xCUBIO multi xCUBIO pharbubble xCUBIO for bacteria xCUBIO cellculture xCUBIO single use xCUBIO process xCUBIO in-situ xCUBIO phar spiral

  5. bbi-biotech – Philosophy No compromises when it comes to sterility! Innovation and customization sets us apart from the competition! We adapt our products to the process of the customer. We never make the customer adapt his process to our products!

  6. bbi-biotech – Sampling & Analytics

  7. bbi-biotech – Guidelines for Sterile Sampling Sterility of the bioreactor and reliable samples first No filters in the bioreactor: Avoid biofilms Avoid cross-contamination: 1 bioreactor – 1 fluid path Avoid cross-contamination: 1 sample – 1 filter

  8. Automated Sterile Sampling – 3 Solutions by bbi-biotech bioPROBE easySAMPLE in-situVALVE

  9. bioPROBE – For all bioreactors plus particular applications bioPROBE single bioPROBE twin/quad

  10. Sample bioPROBE – Schematic overview of the bioPROBE principle Air Pump = stop Pump = start Pressure=ventilate Pressure =1.5 bar Pressure< 1.5 bar Valve = close Valve = open Plate = close Plate = open

  11. bioPROBE – Unique features • Unique features of bioPROBE • Unfiltered and filtered samples (cell-free/cell-containing) • No filter in bioreactor • No dilution by cleaning fluids • Sterility by design • Possibility to work dead-volume free • Disposable GMP and reusable probes • Works with every bioreactor type • Sampling from every position in the bioreactor possible • Direct integration into xCUBIO bioreactor controller possible • Adaptions and customizations possible • Freely configurable and independent from operating system

  12. bioPROBE – Interface • bioPROBE Interface • Configuration via web-browser, no additional software needed • System is independent of OS type • Remote control via web (secure solution available) • 2 independent sampling cycles + custom samples • Complete control of connected autosamplers • Calibration routines, configuration of cleaning method • Logging of all configuration changes and all samples • Different user levels • Easy change between configurations

  13. bioPROBE single • bioPROBE single • Takes samples from ONE bioreactor • Fully automated and working 24 h / 7 d • Minimized human resources demand • Sterile by design • Dead volume free • Starting with volumes of 0.5 ml • With disposable and stainless steel sampling probes • Configurable via PC, tablet or PDA

  14. bioPROBE quad • bioPROBE quad • Takes samples parallel from up to FOUR bioreactors • Fully automated and working 24 h / 7 d • Minimized human resources demand • Completely separated fluid paths • No cross-contamination between bioreactors • With disposable and stainless steel sampling probes • Minimized space requirements

  15. bioPROBE – Comparisonwithfiltrationprobes • No biofouling / No biofilm • No blocked filters • Reliable and representative samples Filtration in Probe Bioreactor

  16. bioPROBE – Sampling withoutcleaningfluids • Completely autark fluid path from reactor to vial • No dilution of samples • No distortion of samples • No “dirty corners” Sterile Air Cleaning Fluid Sample / Waste Bioreactor

  17. bioPROBE – Comparison with sampling from harvest pipe • No distortion by Laminar-Flow • No sampling from „stationary fluid“ • No mixing with previous samples • No substrate limitation

  18. bioPROBE quad – Sterilityby design • No crossing fluid paths • No cross-contamination • No mixing of samples • No dilution of samples

  19. bioPROBE quad – Nocross-contaminationby design From bioreactor to sample vial – Completely autark fluid paths

  20. bioPROBE – Comparisonwithfiltrationprobes bioPROBE vs. Filtration Probe Filtration, storage or analyzers Storage or analyzers Valve Valve Filtrated fluid Works with every bioreactor of every size No filtration! 0.2µm Filter Cell-containing medium

  21. bioPROBE – Probes and hose sets • Probes • Reusable stainless steel probes • GMP-compliant single-use PEEK probes • Hose sets • Hose sets for cleaning with sterile air • Hose sets forcleaning with cleaning fluid • Hose sets of different lengths – 3m, 6m, 9m, 12m, 15m, 18m

  22. easySAMPLE – Economic solution for autoclavable vessels • Based on classical manual sampling method • For autoclavable vessels up to 10l • For every port size • Starting at volumes of 2ml • Single, twin and quad versions • Integrated and stand-alone versions • Compatible with multiSAM and orbitSAM

  23. Sample easySAMPLE – Schematic overview of the easySAMPLE principle Valve (NC) open close Pump start Valve (NC) Valve (NC) close open close open

  24. in-situ VALVE – For medium to large scale in-situ bioreactors • Automated sampling valves • For production-scale bioreactors • For samples with solids up to 5mm • Aerosol-free • Cleaning with steam or cleaning fluid • Optimized connection for steam • Cooling between sampling possible to shorten time between samples

  25. in-situ VALVE – Animation of the functioning principle Steam Sample Waste

  26. in-situVALVE – Schematic overview of the functioning principle • Available versions • Manual • Semi-automated • Fully-automated

  27. Autosamplers and Liquid Handling – 3 solutions by bbi-biotech Lowcost orbitSAM Flexible multiSAM Direct Analytical Connector

  28. orbitSAM – Low budget autosampler for 1 or 2 bioreactors • orbitSAM • Completely automated control viabioPROBE • Compatible with single and twin versions • Interchangeable racks for up to 51 sample vessels • 15 ml, 20 ml, 30 ml or 50 ml sample volume • Sample vessels with septa for aseptic storage available • Easy integration into different lab applications • Optional: cover box with UV-sterilized environment • No cooled storage, no filtration

  29. multiSAM – Most flexible autosampler for diverse applications • multiSAM • Completely automated control viabioPROBE • Customized sample storage vessels • Allows to filtrate samples • Aseptic sample transfer / storage to everywhere • Storing samples from 1 - 4 parallel bioreactors in up to 384 cooled positions • Exact tempering and heating profile control • Optional:multiSAMas disseminator unit for unlimited atline processes • Winner of Industriepreis 2017 in the category Biotechnology

  30. multiSAM – Cooled storage solutions

  31. multiSAM – Filtration • 1 Sample – 1 Filter • Packages available for • Filter cartridges(for medium volumes and uncritical media) • MTP filter plates (for small volumes) • Hollow fiber filters (for large volumes and critical media) • Other filters on demand • Combination with cooled storage packages available

  32. multiSAM – Switching of extension packages • 4 Steps • Change the base plate 3 screws • Change the needle holder 1 screw • Change the cleaning station 0 screws • Change configuration in HMI 1 click • -> It takes less than 5 minutes More than 40 extension packages currently available, open for new ideas.

  33. bioPROBE + multiSAM – More functions with extension packages Standard Vials 13 ml Open Standard Multi-Well Standard Falcon 50 ml Open Standard Falcon 50 ml Septum Standard Falcon 15 ml Open Standard Falcon 15 ml Septum Standard BioprocessBags Standard BioprocessBags XL MTP Filtration ChromafilCartridge Filtration 3ml Chromafil Cartridge Filtration 6ml MediaKap Filtration Peltier Starter (Eppendorf) Water Bath Standard Safety Housing Sterile Housing UV Alarm-To-Cellphone Roche Cedex HiRes Roche Cedex HT Peltier Advanced Laminar-Flow Gmp-Audit-Trail OPC Functionality MACSQuant Vi-Cell XR Customized

  34. Analytics connectors – Overview • MACSQuant Flow Cytometer by MiltenyiBiotec GmbH • Partex Flow Cytometer • Vi-Cell by Beckmann-Coulter • Cedex HiRes by Roche Custom Biotech • Cedex HT by Roche Custom Biotech • YSI Enzyme sensor solutions

  35. Real PAT needs a control circuit

  36. Analytics connectors – Connection of Cedex HiRes • Example Cedex HiRes • Direct connection of sampling device to sampling port of HiRes • No filtration needed

  37. Analytics connectors – Connection of Cedex HT bioPROBE multiSAM Cedex • Pros: • No biofilm / biofouling • Sterile by design • Every sample get a separated filter – one hose set • Each sample – 1 filter – 1 hose set • > 96 samples

  38. bioPROBE – References All trademarksbelongtorespectedowner

  39. Discussion Questions?

  40. More information: www.bbi-biotech.com bbi-biotech GmbH Köpenicker Straße 325, Haus 12 12555 Berlin Germany T +49 30 65 76 39 40 F +49 30 65 76 39 49 sampling@bbi-biotech.com www.bbi-biotech.com

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