“10 Hot Topics in Biomanufacturing”




Vienna, May 20th 2010
Dr. Uwe Gottschalk, VP Purification Technologies,
Sartorius ...
Hot Topic 1: Product Mix, Growth Rates in Business Modells in Biopharma
Hot Topic 1: Product Mix, Growth Rates in Business Modells in Biopharma
Hot Topic 1: Product Mix, Growth Rates in Business Modells in Biopharma
Hot Topic 2: High-Titer Processes in Mammalian Cell Culture




        Data adapted from: F. Wurm Production of recombina...
Hot Topic 2: High-Titer Processes in Mammalian Cell Culture
Hot Topic 3: Downstream Processing is Mass- not Volume Driven




       6th Annual Survey of Biopharmaceutical Manufactur...
Hot Topic 3: Downstream Processing is Mass- not Volume Driven




      Jim Davis, Lonza Economics of Monoclonal Antibody ...
Hot Topic 4: Facility Fit




           Dr. Christian Eckermann, Boehringer Ingelheim 2007
Hot Topic 5: COGs and Price – Margin pressure from both sides

  Technical challenge
            Sensitive and technicall...
Hot Topic 5: COGs and Price – Margin pressure from both sides
Biomanufacturing is fixed cost driven
                      ...
Hot Topic 6: „Biosimilars“ and „Biobetters“
Hot Topic 6: „Biosimilars“ and „Biobetters“
Hot Topic 7: „Offshore Manufacturing“
Hot Topic 8: Technology Platforms

                   Cell Removal/
                    Cell Removal/                Inter...
Hot Topic 8: Technology Platforms– High Titer Implications in DSP

                                                       ...
Hot Topic 9: Emerging Technologies
Hot Topic 9: Emerging Technologies
Biomass Removal and Early Contaminant Clearance
                                       ...
Hot Topic 9: Emerging Technologies
Three Birds – one Stone: Contaminant Precipitation at Medarex addresses:
(now part of B...
Hot Topic 10: Single Use Technologies and „Integrated Processing“
Hot Topic 10: Single Use Technologies and „Integrated Processing“
Hot Topic 10: Single Use Technologies and „Integrated Processing“




         J. Zhou BPI Vienna 2008
Summary: Biomanufacturing 2010+




         “The real voyage of discovery consists not
                in seeking new lan...
Summary: Yes we can!
Thank you!




Uwe.Gottschalk@sartorius-
stedim.com
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Vienna Bpi 2010 Handout

  1. 1. “10 Hot Topics in Biomanufacturing” Vienna, May 20th 2010 Dr. Uwe Gottschalk, VP Purification Technologies, Sartorius Stedim Biotech
  2. 2. Hot Topic 1: Product Mix, Growth Rates in Business Modells in Biopharma
  3. 3. Hot Topic 1: Product Mix, Growth Rates in Business Modells in Biopharma
  4. 4. Hot Topic 1: Product Mix, Growth Rates in Business Modells in Biopharma
  5. 5. Hot Topic 2: High-Titer Processes in Mammalian Cell Culture Data adapted from: F. Wurm Production of recombinant Protein Therapeutics in Cultivated Mammalian Cells. Nature Biotechnology 22, 1-6 (2004)
  6. 6. Hot Topic 2: High-Titer Processes in Mammalian Cell Culture
  7. 7. Hot Topic 3: Downstream Processing is Mass- not Volume Driven 6th Annual Survey of Biopharmaceutical Manufacturing. Eric S. Langer, BioPlan Associates Inc.
  8. 8. Hot Topic 3: Downstream Processing is Mass- not Volume Driven Jim Davis, Lonza Economics of Monoclonal Antibody Production: The relationship between upstream titer and downstream costs; IBC San Diego March 2008
  9. 9. Hot Topic 4: Facility Fit Dr. Christian Eckermann, Boehringer Ingelheim 2007
  10. 10. Hot Topic 5: COGs and Price – Margin pressure from both sides Technical challenge  Sensitive and technically demanding products require processes with inherent complexity and expensive infrastructure  Need for robust & scalable processes for the entire DSP  Increasing regulatory scrutiny (Comparability!) Financial challenge  Processes are fixed-cost driven (Investment vs Consumables)  Manufacturing costs 15 - 25% of sales price  Costs for DSP up to 75% of manufacturing costs  Cost Balance Benefit for innovative treatments  Biosimilars
  11. 11. Hot Topic 5: COGs and Price – Margin pressure from both sides Biomanufacturing is fixed cost driven Category MAb manufacturing: 6 x 2,000L tanks, 2g/L, 90% utilisation; 211 #/a; 527 kg/yr; invest 172 Mio Euro; 142 $/g; Sinclair 2006
  12. 12. Hot Topic 6: „Biosimilars“ and „Biobetters“
  13. 13. Hot Topic 6: „Biosimilars“ and „Biobetters“
  14. 14. Hot Topic 7: „Offshore Manufacturing“
  15. 15. Hot Topic 8: Technology Platforms Cell Removal/ Cell Removal/ Intermediate Intermediate Virus Virus Fermentation Fermentation Capturing Capturing Polishing Polishing Clarification Clarification Purification Purification Clearance Clearance Microorg. CEX HIC Size-Exclusion Size-Exclusion BHK X-FLow Mixed-Mode Ceramic HA AEX (B/E) CHO CHO Centrifuge Centrifuge CEX Inactivation Human Depthfilter Depthfilter Protein A Protein A Gelfiltration AEX (FT) Hybridoma EBA AEX-Membrane AEX-M Adsorption CHO Centr./DF New Aprocess CEX Protein AEX (FT) Orthogonal New process train train New process train ready K. Konstantinov Bayer Corp, USA
  16. 16. Hot Topic 8: Technology Platforms– High Titer Implications in DSP Media Preparation Increasing biomass and contaminant levels Protein A pool volumes Final and step cost concentration / buffer exchange Virus Removal DNA & HCP levels post Capturing Polishing load volumes Fermentation and conductivity Cell Removal/ Clarification Concentration Capturing Polishing
  17. 17. Hot Topic 9: Emerging Technologies
  18. 18. Hot Topic 9: Emerging Technologies Biomass Removal and Early Contaminant Clearance addresses: Increasing biomass and contaminant levels DNA & HCP levels post Capturing • New generation of lenticular filtration media • No Diatomeaceous Earth; Synthetic • Cell removal, clarification & early on contaminant removal
  19. 19. Hot Topic 9: Emerging Technologies Three Birds – one Stone: Contaminant Precipitation at Medarex addresses: (now part of BMS) Fig 7a. precipitation based process Fig 7b. TFF based process Contaminant Protein A pool volumes TFF precipitation and step cost DNA & HCP levels post CEX HCP < 10ng/mg Capturing < 1000 ng/mg CEX HCP Dilution Polishing load volumes Dilution and conductivity Q Membrane Q Membrane HCP < 1000 ng/mg HCP BDL 2 g/ml 20 g/ml Dilution VF Mix Mode Precipitation of Process-Derived Impurities in Non-Protein A VF Purification Schemes for MAb; J. Wang et al. BioPharm Intl. 10/2009, 2-9
  20. 20. Hot Topic 10: Single Use Technologies and „Integrated Processing“
  21. 21. Hot Topic 10: Single Use Technologies and „Integrated Processing“
  22. 22. Hot Topic 10: Single Use Technologies and „Integrated Processing“ J. Zhou BPI Vienna 2008
  23. 23. Summary: Biomanufacturing 2010+ “The real voyage of discovery consists not in seeking new landscapes but in having new eyes.” Marcel Proust. 
  24. 24. Summary: Yes we can!
  25. 25. Thank you! Uwe.Gottschalk@sartorius- stedim.com
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