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Bio Solve Process Cost Model Workshop

The document discusses the evaluation of single-use technologies in biopharmaceutical manufacturing, highlighting the importance of cost modeling for decision-making and efficiency. It emphasizes the rising manufacturing costs, driven by increasing development expenses, and explores factors influencing cost structures, including fixed and variable costs. Additionally, the content outlines the benefits of process modeling to improve cost-effectiveness and streamline production using single-use systems versus traditional stainless steel vessels.

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Tools and Techniques for Evaluating the best fit of Single Use Technologies Single-use technology in biopharmaceutical manufacturing Campus Grüental, Wädenswil. Tuesday 8th June 2010 Andrew Sinclair, President Biopharm Services Ltd, a.sinclair@biopharmservices.com Miriam Monge, VP Global Key Accounts, Biopharm Software Solutions m.monge@biopharmservices.com www.biopharmservices.com © BioPharm Services Ltd CONFIDENTIAL
Agenda Disposables State of the Industry Why use cost models? Building a good biotech process model Understanding cost: example: disposables Cost modelling workshop: mAb case study Summary of results Stainless Steel Discussion © BioPharm Services Ltd CONFIDENTIAL
Acknowledgements Ms. Claire Hill, Biopharm Services Mr. Bruce Williams, MSD biologics/ Avecia Dr. Richard Turner, MedImmune Dr. Brendan Fish, GSK Mr Kit Erlebach, MSD biologics © BioPharm Services Ltd CONFIDENTIAL
BioPharm Services The recognized leading international bioprocess consultancy Our focus is on helping our clients achieve operational excellence with the ultimate goal of delivering more cost effective medicines to patients b i o p h a r m s e r v i c e s Biopharm Engineering & Consultancy Services © BioPharm Services Ltd CONFIDENTIAL
Cost Trends Productivity in development is reducing As spend per drug increases Productivity is decreasing Now overall cost of bring a successful biologic to market is between $0.8bn to $1.2bn Manufacturing costs are increasing proportionately 20 years ago about 3% of sales price for chemical candidate Biologics range between 10% to 20%1 Healthcare providers are putting pressure on the industry to reduce prices by looking at the cost benefit balance2 1. In a recent GE Healthcare webinar they quoted a figure of 14% 2 . The Evidence Gap British Balance Benefit vs. Cost of Latest Drugs, December 3, 2008, New York Times © BioPharm Services Ltd CONFIDENTIAL
Implications for Manufacturing Price Breakdown Manufacturing R&D Sales & G&A Profit share Pre tax profit 14% 37% 21% 9% 19% Manufacturing cost is single variable cost Development costs are fixed and include losses around failed drugs 1. Source GE Healthcare webinar © BioPharm Services Ltd CONFIDENTIAL
Why use models? To answer questions such as… Get the big picture – what are How much will it cost to make the variables? 75kg of product? Make predictions – what will Is it cheaper to use disposable happen if… bags or stainless steel vessels Evaluate alternatives – which one Which plant changes will have is best? the biggest impact on cost? Communication – a simple picture What is the cost/benefit for or chart is better than a thousand installing new technology? words If production falls from 100kg/yr Make better business decisions to 50kg/yr, what will happen to the cost of goods per gram? © BioPharm Services Ltd CONFIDENTIAL
Cost model considerations For manufacturing projects the key parameters to consider are How much has to be spent upfront on capital How long before the facility is operational Proportion of fixed and variable costs The life time of the operation Cost of money © BioPharm Services Ltd CONFIDENTIAL
Cost of Goods – Cost of Production Includes just manufacturing costs Facility Materials Consumables Labour Does not include Sales, General & Admin R&D Interest & Taxes Why is it used? Provides insight into cost drivers Allowing analysis of process and technologies Snapshot Costs over a defined (short term) period No overall lifecycle costs Failure © BioPharm Services Ltd CONFIDENTIAL
Fixed vs. variable costs Fixed: Capital, some materials Variable: Materials, consumables & labour & some labour Also referred to as direct/indirect costs in cost accounting. © BioPharm Services Ltd CONFIDENTIAL
Cost model components “Fixed” costs Variable costs Size of facility (how Materials much capital was Consumables initially invested) Labour Base facility running Utilities/waste costs (insurance, electricity, etc.) Productivity Administration Batches per year (receptionist, etc) Batch size Air filters © BioPharm Services Ltd CONFIDENTIAL
Driving Down Cost of Goods Product Priorities Process Development $100s millions Higher titres Better match the process to the facility Chromatography matrices Filtration rates/membranes Increased benefits Design Good Facility design $100s millions Appropriate process equipment Appropriate infrastructure (neither too` small nor too large) Latest manufacturing technologies Platform Technologies Continuous processing Integrated operations $10s millions Integrated disposables Manufacturing Appropriate process equipment Optimum working practices $10s millions © BioPharm Services Ltd CONFIDENTIAL
Building a good biotech Process model Understand the manufacturing process Resource requirements Timing Understand the cost structure Fixed/variable – not always obvious Beware of hidden costs Activity-based costing (ABC) can help with this Understand where to make assumptions Impossible to model all variables Can introduce more error by false confidence © BioPharm Services Ltd CONFIDENTIAL
BioSolve: Configurable CoGs Model Process Definition MAb Typical Rapid process configuration Product Titre Capacity Utilisation 5.00 g/L 80% Rapid option evaluation Production Bioreactor Volume 5000 L Technologies Single-Use Systems Processes Bioreactors (up to 2000L) No Scalable mass balance Media Preparation (up to 2000L) Yes Buffer Preparation (up to 2000L) No Standard format Process Sequence Conc (g/L) Vol (L) Mass (g) Yield (%) Time (h) Consumables estimates 1 N-2 Seed 0.0 50 0 0% 58.0 Scalable equipment list 2 N-1 Seed 0.0 500 0 0% 59.0 3 Production 5.0 5,000 25,000 0% 210.0 Based on standard costs, sizes 4 Centrifugation 5.0 4,250 21,250 85% 9.0 5 Depth Filtration 4.3 4,250 18,063 85% 9.2 Basis for capital cost estimate 6 UF/DF #1 40.4 425 17,159 95% 12.4 7 Protein A 3.1 4,926 15,443 90% 12.9 Insight into utilities, environment 8 Virus Inactivation 3.0 5,025 15,135 98% 2.5 9 Capture IEX 7.8 1,847 14,378 95% 11.4 PW & WFI 10 Flow Through IEX 7.4 1,847 13,659 95% 6.2 11 Viral Filtration 7.2 1,847 13,386 98% 9.3 Waste streams 12 13 UF/DF #2 Sterile Filtration 35.5 34.8 369 369 13,118 12,856 98% 98% 12.4 9.1 Capacity and capital estimates © BioPharm Services Ltd CONFIDENTIAL
Process Cost Model Features Scalable Mass balance calculations Step times Process Interface Calculation Outputs Equipment/consumable sizing Labour requirements Production Customisation Utility requirements Dashboard Bill of Technology Options Labour Materials Process Description Scenarios Solution prep methodology Consumables Disposable systems Cost of Goods & Materials Sensitivity Mode of operation (fed- batch vs. perfusion, packed Equipment Capital bed vs. EBA, etc) Cost Database Equipment Consumables Materials Labour Waste treatment © BioPharm Services Ltd CONFIDENTIAL
Applications Process development Rapid, multiple scenario analysis in process development • Impact of different titers • Expression systems (E. coli versus mammalian) • Crystallisation vs. Protein A Technology assessment Analyse the impact of a specific technology within a process for example • Disposable bags vs. stainless • Membrane chromatography • Perfusion vs. fed batch Manufacturing First past analysis • Facility fit • Manufacturing scenarios • Process improvement screening © BioPharm Services Ltd CONFIDENTIAL
BioSolve Output (Water) How Does it Compare Stainless Steel % Water Used for CIP 100% 90% 80% 70% Actual 60% BioSolve 50% Power (Actual) 40% 0 10,000 20,000 30,000 40,000 50,000 60,000 Bioreactor Harvest Volume L © BioPharm Services Ltd CONFIDENTIAL
Capital Estimate Comparison © BioPharm Services Ltd CONFIDENTIAL
Case Study Assumptions For client confidentiality, the process was based on a generic MAb production data* 3 x 2,000L; 2g/L, 80% utilisation One purification train Mode of solution make-up Media: per batch Buffer: per batch Basis of costs (i.e. materials, consumables, equipment etc.) Vendors, suppliers, benchmarking information from over 10 biotech operations * Morrow, K. J. Industrial-Scale Antibody Production Strategies. Genet. Eng News, 22(17), 8-71, 2002 © BioPharm Services Ltd CONFIDENTIAL
BioSolve Disposable Options Using MAb Typical Set up SS facility base case Disposable options generic* Bags impact Mixing system options Bioreactors Sensitivity Hold bag costs Bioreactor pricing  Consumables  Hardware Analysing Individual Operations Membrane absorber* *Based on average vendor pricing © BioPharm Services Ltd CONFIDENTIAL
Performance © BioPharm Services Ltd CONFIDENTIAL
Impact of Single Use vs. Reusable Water Key indicator of the impact of disposables Plastics Key indicator of the solid waste stream Capital infrastructure Labour Materials © BioPharm Services Ltd CONFIDENTIAL
Stainless Steel Option • Capital $ 60.6M • CoG 174.5 $/g © BioPharm Services Ltd CONFIDENTIAL
Hold bags option • Capital $ 43.3M • CoG 144.3 $/g © BioPharm Services Ltd So what is happening? CONFIDENTIAL
Metrics Stainless Option Plastic (kg) Plastic Waste 66.2 Process (m3) Cleaning (m3) Water 11.5 73.1 Usage Media Prep Media Hold Buffer Prep Buffer Hold Product Hold Vessels 4 4 12 12 11 Bags 0 0 0 0 0 Hold Bag Option Plastic (kg) Plastic Waste 167.6 Process (m3) Cleaning (m3) Water 11.5 24.8 Usage Media Prep Media Hold Buffer Prep Buffer Hold Product Hold Vessels 0 12 0 0 Bags 0 4 0 13 11 © BioPharm Services Ltd CONFIDENTIAL
Impact on CIP – Cleaning Lists 0.04M Unit Volume Flowrate Flowrate Time Labour Equip Type Description PW 0.2M NaOH Phosphoric PW WFI Op (L) (L/hr) (L/min) (hr) (hr) Acid 1 Bioreactor Bioreactor 20 0 37 2 4.0 183 183 183 183 183 2 Bioreactor Bioreactor 200 0 79 3 6.0 395 395 395 395 395 3 Bioreactor Bioreactor 2,000 0 170 4 8.0 851 851 851 851 851 4 Centrifuge Disk Stack Centrifuge 0 400 20 2 4.0 100 100 100 100 100 5 Filter HousingDepth Filter 0 440 22 3 6.0 110 110 110 110 110 6 UF Skid UF Filter 0 638 32 4 8.0 160 160 0 160 160 11 Filter HousingViral Filter 0 120 6 3 6.0 30 30 30 30 30 12 UF Skid UF Filter 0 182 9 4 8.0 46 46 0 46 46 0.04M Unit Volume Flowrate Flowrate Time Labour 3 Vessel Product Hold 2,000 0 170 1 2.0 851 851 851 851 851 Equip Type Description PW 0.2M NaOH Phosphoric PW WFI 4 Vessel Product Hold 2,000 0 170 1 2.0 851 851 851 851 851 Op (L) (L/hr) (L/min) (hr) (hr) Acid 5 Vessel Product Hold 2,000 0 170 1 2.0 851 851 851 851 851 6 Vessel Product Hold 200 0 79 1 2.0 395 395 395 395 395 1 Bioreactor Bioreactor 20 0 37 2 4.0 183 183 183 183 183 7 Vessel Product Hold 750 0 123 1 2.0 614 614 614 614 614 2 Bioreactor Bioreactor 200 0 79 3 6.0 395 395 395 395 395 8 Vessel Product Hold 1,000 0 135 1 2.0 676 676 676 676 676 3 Bioreactor Bioreactor 2,000 0 170 4 8.0 851 851 851 851 851 9 Vessel Product Hold 500 0 107 1 2.0 536 536 536 536 536 4 Centrifuge Disk Stack Centrifuge 0 400 20 2 4.0 100 100 100 100 100 10 Vessel Product Hold 500 0 107 1 2.0 536 536 536 536 536 11 Vessel Product Hold 500 0 107 1 2.0 536 536 536 536 536 5 Filter HousingDepth Filter 0 440 22 3 6.0 110 110 110 110 110 12 Vessel Product Hold 100 0 63 1 2.0 314 314 314 314 314 6 UF Skid UF Filter 0 638 32 4 8.0 160 160 0 160 160 13 Vessel Product Hold 100 0 63 1 2.0 314 314 314 314 314 11 Filter HousingViral Filter 0 120 6 3 6.0 30 30 30 30 30 1 Vessel Media Prep / Hold 200 0 79 1 2.0 395 395 395 395 395 12 UF Skid UF Filter 0 182 9 4 8.0 46 46 0 46 46 1 Vessel Media Prep / Hold 200 0 79 1 2.0 395 395 395 395 395 3 Vessel Media Prep / Hold 50 0 50 1 2.0 249 249 249 249 249 1 Vessel Media Prep / Hold 200 0 79 1 2.0 395 395 395 395 395 3 Vessel Media Prep / Hold 50 0 50 1 2.0 249 249 249 249 249 3 Vessel Media Prep / Hold 50 0 50 1 2.0 249 249 249 249 249 3 Vessel Media Prep / Hold 50 0 50 1 2.0 249 249 249 249 249 3 Vessel Media Prep / Hold 50 0 50 1 2.0 249 249 249 249 249 3 Vessel Media Prep / Hold 50 0 50 1 2.0 249 249 249 249 249 3 Vessel Media Prep / Hold 2,000 0 170 1 2.0 851 851 851 851 851 3 Vessel Media Prep / Hold 2,000 0 170 1 2.0 851 851 851 851 851 3 Vessel Media Prep / Hold 2,000 0 170 1 2.0 851 851 851 851 851 6 Vessel Buffer Prep / Hold 200 0 79 0.2 0.4 0 0 0 0 395 6 Vessel Buffer Prep / Hold 200 0 79 0.2 0.4 0 0 0 0 395 6 Vessel Buffer Prep / Hold 1,000 0 135 0.2 0.4 0 0 0 0 676 6 Vessel Buffer Prep / Hold 200 0 79 0.2 0.4 0 0 0 0 395 7 Vessel Buffer Prep / Hold 150 0 72 0.2 0.4 0 0 0 0 359 6 Vessel Buffer Prep / Hold 1,000 0 135 0.2 0.4 0 0 0 0 676 6 Vessel Buffer Prep / Hold 1,000 0 135 0.2 0.4 0 0 0 0 676 7 Vessel Buffer Prep / Hold 1,000 0 135 0.2 0.4 0 0 0 0 676 7 Vessel Buffer Prep / Hold 150 0 72 0.2 0.4 0 0 0 0 359 7 Vessel Buffer Prep / Hold 3,000 0 195 0.2 0.4 0 0 0 0 974 7 Vessel Buffer Prep / Hold 150 0 72 0.2 0.4 0 0 0 0 359 8 Vessel Buffer Prep / Hold 25 0 40 0.2 0.4 0 0 0 0 198 7 Vessel Buffer Prep / Hold 1,000 0 135 0.2 0.4 0 0 0 0 676 8 Vessel Buffer Prep / Hold 25 0 40 0.2 0.4 0 0 0 0 198 7 Vessel Buffer Prep / Hold 1,000 0 135 0.2 0.4 0 0 0 0 676 7 Vessel Buffer Prep / Hold 3,000 0 195 0.2 0.4 0 0 0 0 974 9 Vessel Buffer Prep / Hold 500 0 107 0.2 0.4 0 0 0 0 536 7 Vessel Buffer Prep / Hold 3,000 0 195 0.2 0.4 0 0 0 0 974 9 Vessel Buffer Prep / Hold 500 0 107 0.2 0.4 0 0 0 0 536 8 Vessel Buffer Prep / Hold 25 0 40 0.2 0.4 0 0 0 0 198 9 Vessel Buffer Prep / Hold 500 0 107 0.2 0.4 0 0 0 0 536 8 Vessel Buffer Prep / Hold 25 0 40 0.2 0.4 0 0 0 0 198 8 Vessel Buffer Prep / Hold 25 0 40 0.2 0.4 0 0 0 0 198 9 Vessel Buffer Prep / Hold 1,500 0 155 0.2 0.4 0 0 0 0 773 8 Vessel Buffer Prep / Hold 25 0 40 0.2 0.4 0 0 0 0 198 10 Vessel Buffer Prep / Hold 200 0 79 0.2 0.4 0 0 0 0 395 9 Vessel Buffer Prep / Hold 500 0 107 0.2 0.4 0 0 0 0 536 10 Vessel Buffer Prep / Hold 200 0 79 0.2 0.4 0 0 0 0 395 9 Vessel Buffer Prep / Hold 500 0 107 0.2 0.4 0 0 0 0 536 10 Vessel Buffer Prep / Hold 200 0 79 0.2 0.4 0 0 0 0 395 9 Vessel Buffer Prep / Hold 500 0 107 0.2 0.4 0 0 0 0 536 9 Vessel Buffer Prep / Hold 500 0 107 0.2 0.4 0 0 0 0 536 10 Vessel Buffer Prep / Hold 500 0 107 0.2 0.4 0 0 0 0 536 9 Vessel Buffer Prep / Hold 500 0 107 0.2 0.4 0 0 0 0 536 11 Vessel Buffer Prep / Hold 25 0 40 0.2 0.4 0 0 0 0 198 9 Vessel Buffer Prep / Hold 500 0 107 0.2 0.4 0 0 0 0 536 12 Vessel Buffer Prep / Hold 50 0 50 0.2 0.4 0 0 0 0 249 9 Vessel Buffer Prep / Hold 1,500 0 155 0.2 0.4 0 0 0 0 773 12 Vessel Buffer Prep / Hold 500 0 107 0.2 0.4 0 0 0 0 536 9 Vessel Buffer Prep / Hold 1,500 0 155 0.2 0.4 0 0 0 0 773 10 Vessel Buffer Prep / Hold 200 0 79 0.2 0.4 0 0 0 0 395 Hold bag cleaning list 10 Vessel Buffer Prep / Hold 200 0 79 0.2 0.4 0 0 0 0 395 10 Vessel Buffer Prep / Hold 200 0 79 0.2 0.4 0 0 0 0 395 10 Vessel Buffer Prep / Hold 200 0 79 0.2 0.4 0 0 0 0 395 10 Vessel Buffer Prep / Hold 200 0 79 0.2 0.4 0 0 0 0 395 A significant reduction in cleaning 10 Vessel Buffer Prep / Hold 200 0 79 0.2 0.4 0 0 0 0 395 10 Vessel Buffer Prep / Hold 500 0 107 0.2 0.4 0 0 0 0 536 10 Vessel Buffer Prep / Hold 500 0 107 0.2 0.4 0 0 0 0 536 operations 11 Vessel Buffer Prep / Hold 25 0 40 0.2 0.4 0 0 0 0 198 11 Vessel Buffer Prep / Hold 25 0 40 0.2 0.4 0 0 0 0 198 12 Vessel Buffer Prep / Hold 50 0 50 0.2 0.4 0 0 0 0 249 12 Vessel Buffer Prep / Hold 50 0 50 0.2 0.4 0 0 0 0 249 12 Vessel Buffer Prep / Hold 500 0 107 0.2 0.4 0 0 0 0 536 12 Vessel Buffer Prep / Hold 500 0 107 0.2 0.4 0 0 0 0 536 Stainless cleaning list © BioPharm Services Ltd CONFIDENTIAL
Impact of Disposables on Water At this point stainless steel starts to Using multiple bags take over from disposables based on instead of larger vessels vessel size Maximises water saving © BioPharm Services Ltd CONFIDENTIAL
Why SS majority of water used for cleaning At 1000L 90% used for CIP Disposables significantly reduce water load A 10 fold reduction at 1,000L scale 3 fold at 10,000L scale (best case) which may not be practical © BioPharm Services Ltd CONFIDENTIAL
Scenario Analysis – Rapid Evaluation of Options Scenario Definition Base Hold Bio Liner Mixer Membrane Single-Use Systems Bioreactors (up to 2000L) No No Yes No No No Media Preparation (up to 2000L) No No No No No No Buffer Preparation (up to 2000L) No No No Yes Yes No Type of Buffer Prep System Liner Liner Liner Liner Bag System Liner Media and Buffer Hold (up to 3000L) No Yes No No No No Intermediate Product Hold (up to 2000L) No Yes No No No No Use Stainless Steel above Threshold No No No No No No Threshold Volume 2000 2000 2000 2000 2000 2000 Membrane Adsorber for Flowthrough No No No No No Yes Size of MA Capsule 10 10 10 10 10 10 Batches per year 90 90 94 90 90 90 Throughput (kg or doses per year) 185 185 193 185 185 185 Total capital (US$ M) 60.6 43.3 46.2 56.0 57.1 56.7 0.0% -28.6% -23.7% -7.6% -5.7% -6.4% Cost per gram (US$) 174.46 144.28 153.80 168.02 172.61 168.97 0.0% -17.3% -11.8% -3.7% -1.1% -3.1% Capital Charge 68.53 48.93 50.07 63.35 64.62 64.12 0.0% -28.6% -26.9% -7.6% -5.7% -6.4% Materials 26.47 25.55 26.31 26.47 26.47 26.32 0.0% -3.5% -0.6% 0.0% 0.0% -0.5% Consumables 20.55 28.59 27.06 20.89 23.89 21.12 0.0% 39.1% 31.7% 1.7% 16.3% 2.8% Labour 40.24 28.43 36.33 40.06 40.06 39.85 0.0% -29.4% -9.7% -0.5% -0.5% -1.0% Others 18.67 12.78 14.04 17.26 17.57 17.55 0.0% -31.6% -24.8% -7.5% -5.9% -6.0% © BioPharm Services Ltd CONFIDENTIAL
Pricing © BioPharm Services Ltd CONFIDENTIAL
Hold Bag Pricing Hold Bag Pricing Price $/g ∆ CoG 25% 141.52 -1.9% 50% 142.44 -1.3% 75% 143.36 -0.6% 100% 144.28 0.0% 125% 145.20 0.6% 150% 146.12 1.3% 175% 147.04 1.9% 200% 147.96 2.6% 225% 148.88 3.2% 250% 149.80 3.8% © BioPharm Services Ltd CONFIDENTIAL
Bioreactor Bag Pricing Bioreactor Bag Pricing Price $/g ∆ CoG 25% 148.92 -3.2% 50% 150.55 -2.1% 75% 152.17 -1.1% 100% 153.80 0.0% 125% 155.43 1.1% 150% 157.06 2.1% 175% 158.69 3.2% 200% 160.32 4.2% 225% 161.94 5.3% 250% 163.57 6.4% © BioPharm Services Ltd CONFIDENTIAL
Bioreactor Hardware Pricing Bioreactor System Pricing Price $/g ∆ CoG 25% 138.22 -10.1% 50% 143.42 -6.8% 75% 148.61 -3.4% 100% 153.80 0.0% 125% 158.99 3.4% 150% 164.19 6.8% 175% 169.38 10.1% 200% 174.57 13.5% 225% 179.77 16.9% 250% 184.96 20.3% © BioPharm Services Ltd CONFIDENTIAL
Conclusions © BioPharm Services Ltd CONFIDENTIAL
Conclusions To drive out cost in biologics manufacturing Many challenges remain The earlier in development the better Carefully evaluate the technologies It is important to understand the costs: Remove opinion its not always obvious Provide insight – understand the drivers Reduce risk Cost Modelling Provides insight Helps make informed decisions Single Use Systems We have demonstrated that they have a significant role This is a function of price, scale and process Process cost modelling is important to support targeted cost effective applications © BioPharm Services Ltd CONFIDENTIAL

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Bio Solve Process Cost Model Workshop

  • 1.
    Tools and Techniquesfor Evaluating the best fit of Single Use Technologies Single-use technology in biopharmaceutical manufacturing Campus Grüental, Wädenswil. Tuesday 8th June 2010 Andrew Sinclair, President Biopharm Services Ltd, a.sinclair@biopharmservices.com Miriam Monge, VP Global Key Accounts, Biopharm Software Solutions m.monge@biopharmservices.com www.biopharmservices.com © BioPharm Services Ltd CONFIDENTIAL
  • 2.
    Agenda Disposables State of the Industry Why use cost models? Building a good biotech process model Understanding cost: example: disposables Cost modelling workshop: mAb case study Summary of results Stainless Steel Discussion © BioPharm Services Ltd CONFIDENTIAL
  • 3.
    Acknowledgements Ms. Claire Hill, Biopharm Services Mr. Bruce Williams, MSD biologics/ Avecia Dr. Richard Turner, MedImmune Dr. Brendan Fish, GSK Mr Kit Erlebach, MSD biologics © BioPharm Services Ltd CONFIDENTIAL
  • 4.
    BioPharm Services The recognized leading international bioprocess consultancy Our focus is on helping our clients achieve operational excellence with the ultimate goal of delivering more cost effective medicines to patients b i o p h a r m s e r v i c e s Biopharm Engineering & Consultancy Services © BioPharm Services Ltd CONFIDENTIAL
  • 5.
    Cost Trends Productivity in development is reducing As spend per drug increases Productivity is decreasing Now overall cost of bring a successful biologic to market is between $0.8bn to $1.2bn Manufacturing costs are increasing proportionately 20 years ago about 3% of sales price for chemical candidate Biologics range between 10% to 20%1 Healthcare providers are putting pressure on the industry to reduce prices by looking at the cost benefit balance2 1. In a recent GE Healthcare webinar they quoted a figure of 14% 2 . The Evidence Gap British Balance Benefit vs. Cost of Latest Drugs, December 3, 2008, New York Times © BioPharm Services Ltd CONFIDENTIAL
  • 6.
    Implications for Manufacturing Price Breakdown Manufacturing R&D Sales & G&A Profit share Pre tax profit 14% 37% 21% 9% 19% Manufacturing cost is single variable cost Development costs are fixed and include losses around failed drugs 1. Source GE Healthcare webinar © BioPharm Services Ltd CONFIDENTIAL
  • 7.
    Why use models? To answer questions such as… Get the big picture – what are How much will it cost to make the variables? 75kg of product? Make predictions – what will Is it cheaper to use disposable happen if… bags or stainless steel vessels Evaluate alternatives – which one Which plant changes will have is best? the biggest impact on cost? Communication – a simple picture What is the cost/benefit for or chart is better than a thousand installing new technology? words If production falls from 100kg/yr Make better business decisions to 50kg/yr, what will happen to the cost of goods per gram? © BioPharm Services Ltd CONFIDENTIAL
  • 8.
    Cost model considerations For manufacturing projects the key parameters to consider are How much has to be spent upfront on capital How long before the facility is operational Proportion of fixed and variable costs The life time of the operation Cost of money © BioPharm Services Ltd CONFIDENTIAL
  • 9.
    Cost of Goods– Cost of Production Includes just manufacturing costs Facility Materials Consumables Labour Does not include Sales, General & Admin R&D Interest & Taxes Why is it used? Provides insight into cost drivers Allowing analysis of process and technologies Snapshot Costs over a defined (short term) period No overall lifecycle costs Failure © BioPharm Services Ltd CONFIDENTIAL
  • 10.
    Fixed vs. variablecosts Fixed: Capital, some materials Variable: Materials, consumables & labour & some labour Also referred to as direct/indirect costs in cost accounting. © BioPharm Services Ltd CONFIDENTIAL
  • 11.
    Cost model components “Fixed” costs Variable costs Size of facility (how Materials much capital was Consumables initially invested) Labour Base facility running Utilities/waste costs (insurance, electricity, etc.) Productivity Administration Batches per year (receptionist, etc) Batch size Air filters © BioPharm Services Ltd CONFIDENTIAL
  • 12.
    Driving Down Costof Goods Product Priorities Process Development $100s millions Higher titres Better match the process to the facility Chromatography matrices Filtration rates/membranes Increased benefits Design Good Facility design $100s millions Appropriate process equipment Appropriate infrastructure (neither too` small nor too large) Latest manufacturing technologies Platform Technologies Continuous processing Integrated operations $10s millions Integrated disposables Manufacturing Appropriate process equipment Optimum working practices $10s millions © BioPharm Services Ltd CONFIDENTIAL
  • 13.
    Building a goodbiotech Process model Understand the manufacturing process Resource requirements Timing Understand the cost structure Fixed/variable – not always obvious Beware of hidden costs Activity-based costing (ABC) can help with this Understand where to make assumptions Impossible to model all variables Can introduce more error by false confidence © BioPharm Services Ltd CONFIDENTIAL
  • 14.
    BioSolve: Configurable CoGsModel Process Definition MAb Typical Rapid process configuration Product Titre Capacity Utilisation 5.00 g/L 80% Rapid option evaluation Production Bioreactor Volume 5000 L Technologies Single-Use Systems Processes Bioreactors (up to 2000L) No Scalable mass balance Media Preparation (up to 2000L) Yes Buffer Preparation (up to 2000L) No Standard format Process Sequence Conc (g/L) Vol (L) Mass (g) Yield (%) Time (h) Consumables estimates 1 N-2 Seed 0.0 50 0 0% 58.0 Scalable equipment list 2 N-1 Seed 0.0 500 0 0% 59.0 3 Production 5.0 5,000 25,000 0% 210.0 Based on standard costs, sizes 4 Centrifugation 5.0 4,250 21,250 85% 9.0 5 Depth Filtration 4.3 4,250 18,063 85% 9.2 Basis for capital cost estimate 6 UF/DF #1 40.4 425 17,159 95% 12.4 7 Protein A 3.1 4,926 15,443 90% 12.9 Insight into utilities, environment 8 Virus Inactivation 3.0 5,025 15,135 98% 2.5 9 Capture IEX 7.8 1,847 14,378 95% 11.4 PW & WFI 10 Flow Through IEX 7.4 1,847 13,659 95% 6.2 11 Viral Filtration 7.2 1,847 13,386 98% 9.3 Waste streams 12 13 UF/DF #2 Sterile Filtration 35.5 34.8 369 369 13,118 12,856 98% 98% 12.4 9.1 Capacity and capital estimates © BioPharm Services Ltd CONFIDENTIAL
  • 15.
    Process Cost ModelFeatures Scalable Mass balance calculations Step times Process Interface Calculation Outputs Equipment/consumable sizing Labour requirements Production Customisation Utility requirements Dashboard Bill of Technology Options Labour Materials Process Description Scenarios Solution prep methodology Consumables Disposable systems Cost of Goods & Materials Sensitivity Mode of operation (fed- batch vs. perfusion, packed Equipment Capital bed vs. EBA, etc) Cost Database Equipment Consumables Materials Labour Waste treatment © BioPharm Services Ltd CONFIDENTIAL
  • 16.
    Applications Process development Rapid, multiple scenario analysis in process development • Impact of different titers • Expression systems (E. coli versus mammalian) • Crystallisation vs. Protein A Technology assessment Analyse the impact of a specific technology within a process for example • Disposable bags vs. stainless • Membrane chromatography • Perfusion vs. fed batch Manufacturing First past analysis • Facility fit • Manufacturing scenarios • Process improvement screening © BioPharm Services Ltd CONFIDENTIAL
  • 17.
    BioSolve Output (Water) How Does it Compare Stainless Steel % Water Used for CIP 100% 90% 80% 70% Actual 60% BioSolve 50% Power (Actual) 40% 0 10,000 20,000 30,000 40,000 50,000 60,000 Bioreactor Harvest Volume L © BioPharm Services Ltd CONFIDENTIAL
  • 18.
    Capital Estimate Comparison ©BioPharm Services Ltd CONFIDENTIAL
  • 19.
    Case Study Assumptions For client confidentiality, the process was based on a generic MAb production data* 3 x 2,000L; 2g/L, 80% utilisation One purification train Mode of solution make-up Media: per batch Buffer: per batch Basis of costs (i.e. materials, consumables, equipment etc.) Vendors, suppliers, benchmarking information from over 10 biotech operations * Morrow, K. J. Industrial-Scale Antibody Production Strategies. Genet. Eng News, 22(17), 8-71, 2002 © BioPharm Services Ltd CONFIDENTIAL
  • 20.
    BioSolve Disposable Options Using MAb Typical Set up SS facility base case Disposable options generic* Bags impact Mixing system options Bioreactors Sensitivity Hold bag costs Bioreactor pricing  Consumables  Hardware Analysing Individual Operations Membrane absorber* *Based on average vendor pricing © BioPharm Services Ltd CONFIDENTIAL
  • 21.
  • 22.
    Impact of SingleUse vs. Reusable Water Key indicator of the impact of disposables Plastics Key indicator of the solid waste stream Capital infrastructure Labour Materials © BioPharm Services Ltd CONFIDENTIAL
  • 23.
    Stainless Steel Option • Capital $ 60.6M • CoG 174.5 $/g © BioPharm Services Ltd CONFIDENTIAL
  • 24.
    Hold bags option • Capital $ 43.3M • CoG 144.3 $/g © BioPharm Services Ltd So what is happening? CONFIDENTIAL
  • 25.
    Metrics Stainless Option Plastic (kg) Plastic Waste 66.2 Process (m3) Cleaning (m3) Water 11.5 73.1 Usage Media Prep Media Hold Buffer Prep Buffer Hold Product Hold Vessels 4 4 12 12 11 Bags 0 0 0 0 0 Hold Bag Option Plastic (kg) Plastic Waste 167.6 Process (m3) Cleaning (m3) Water 11.5 24.8 Usage Media Prep Media Hold Buffer Prep Buffer Hold Product Hold Vessels 0 12 0 0 Bags 0 4 0 13 11 © BioPharm Services Ltd CONFIDENTIAL
  • 26.
    Impact on CIP– Cleaning Lists 0.04M Unit Volume Flowrate Flowrate Time Labour Equip Type Description PW 0.2M NaOH Phosphoric PW WFI Op (L) (L/hr) (L/min) (hr) (hr) Acid 1 Bioreactor Bioreactor 20 0 37 2 4.0 183 183 183 183 183 2 Bioreactor Bioreactor 200 0 79 3 6.0 395 395 395 395 395 3 Bioreactor Bioreactor 2,000 0 170 4 8.0 851 851 851 851 851 4 Centrifuge Disk Stack Centrifuge 0 400 20 2 4.0 100 100 100 100 100 5 Filter HousingDepth Filter 0 440 22 3 6.0 110 110 110 110 110 6 UF Skid UF Filter 0 638 32 4 8.0 160 160 0 160 160 11 Filter HousingViral Filter 0 120 6 3 6.0 30 30 30 30 30 12 UF Skid UF Filter 0 182 9 4 8.0 46 46 0 46 46 0.04M Unit Volume Flowrate Flowrate Time Labour 3 Vessel Product Hold 2,000 0 170 1 2.0 851 851 851 851 851 Equip Type Description PW 0.2M NaOH Phosphoric PW WFI 4 Vessel Product Hold 2,000 0 170 1 2.0 851 851 851 851 851 Op (L) (L/hr) (L/min) (hr) (hr) Acid 5 Vessel Product Hold 2,000 0 170 1 2.0 851 851 851 851 851 6 Vessel Product Hold 200 0 79 1 2.0 395 395 395 395 395 1 Bioreactor Bioreactor 20 0 37 2 4.0 183 183 183 183 183 7 Vessel Product Hold 750 0 123 1 2.0 614 614 614 614 614 2 Bioreactor Bioreactor 200 0 79 3 6.0 395 395 395 395 395 8 Vessel Product Hold 1,000 0 135 1 2.0 676 676 676 676 676 3 Bioreactor Bioreactor 2,000 0 170 4 8.0 851 851 851 851 851 9 Vessel Product Hold 500 0 107 1 2.0 536 536 536 536 536 4 Centrifuge Disk Stack Centrifuge 0 400 20 2 4.0 100 100 100 100 100 10 Vessel Product Hold 500 0 107 1 2.0 536 536 536 536 536 11 Vessel Product Hold 500 0 107 1 2.0 536 536 536 536 536 5 Filter HousingDepth Filter 0 440 22 3 6.0 110 110 110 110 110 12 Vessel Product Hold 100 0 63 1 2.0 314 314 314 314 314 6 UF Skid UF Filter 0 638 32 4 8.0 160 160 0 160 160 13 Vessel Product Hold 100 0 63 1 2.0 314 314 314 314 314 11 Filter HousingViral Filter 0 120 6 3 6.0 30 30 30 30 30 1 Vessel Media Prep / Hold 200 0 79 1 2.0 395 395 395 395 395 12 UF Skid UF Filter 0 182 9 4 8.0 46 46 0 46 46 1 Vessel Media Prep / Hold 200 0 79 1 2.0 395 395 395 395 395 3 Vessel Media Prep / Hold 50 0 50 1 2.0 249 249 249 249 249 1 Vessel Media Prep / Hold 200 0 79 1 2.0 395 395 395 395 395 3 Vessel Media Prep / Hold 50 0 50 1 2.0 249 249 249 249 249 3 Vessel Media Prep / Hold 50 0 50 1 2.0 249 249 249 249 249 3 Vessel Media Prep / Hold 50 0 50 1 2.0 249 249 249 249 249 3 Vessel Media Prep / Hold 50 0 50 1 2.0 249 249 249 249 249 3 Vessel Media Prep / Hold 50 0 50 1 2.0 249 249 249 249 249 3 Vessel Media Prep / Hold 2,000 0 170 1 2.0 851 851 851 851 851 3 Vessel Media Prep / Hold 2,000 0 170 1 2.0 851 851 851 851 851 3 Vessel Media Prep / Hold 2,000 0 170 1 2.0 851 851 851 851 851 6 Vessel Buffer Prep / Hold 200 0 79 0.2 0.4 0 0 0 0 395 6 Vessel Buffer Prep / Hold 200 0 79 0.2 0.4 0 0 0 0 395 6 Vessel Buffer Prep / Hold 1,000 0 135 0.2 0.4 0 0 0 0 676 6 Vessel Buffer Prep / Hold 200 0 79 0.2 0.4 0 0 0 0 395 7 Vessel Buffer Prep / Hold 150 0 72 0.2 0.4 0 0 0 0 359 6 Vessel Buffer Prep / Hold 1,000 0 135 0.2 0.4 0 0 0 0 676 6 Vessel Buffer Prep / Hold 1,000 0 135 0.2 0.4 0 0 0 0 676 7 Vessel Buffer Prep / Hold 1,000 0 135 0.2 0.4 0 0 0 0 676 7 Vessel Buffer Prep / Hold 150 0 72 0.2 0.4 0 0 0 0 359 7 Vessel Buffer Prep / Hold 3,000 0 195 0.2 0.4 0 0 0 0 974 7 Vessel Buffer Prep / Hold 150 0 72 0.2 0.4 0 0 0 0 359 8 Vessel Buffer Prep / Hold 25 0 40 0.2 0.4 0 0 0 0 198 7 Vessel Buffer Prep / Hold 1,000 0 135 0.2 0.4 0 0 0 0 676 8 Vessel Buffer Prep / Hold 25 0 40 0.2 0.4 0 0 0 0 198 7 Vessel Buffer Prep / Hold 1,000 0 135 0.2 0.4 0 0 0 0 676 7 Vessel Buffer Prep / Hold 3,000 0 195 0.2 0.4 0 0 0 0 974 9 Vessel Buffer Prep / Hold 500 0 107 0.2 0.4 0 0 0 0 536 7 Vessel Buffer Prep / Hold 3,000 0 195 0.2 0.4 0 0 0 0 974 9 Vessel Buffer Prep / Hold 500 0 107 0.2 0.4 0 0 0 0 536 8 Vessel Buffer Prep / Hold 25 0 40 0.2 0.4 0 0 0 0 198 9 Vessel Buffer Prep / Hold 500 0 107 0.2 0.4 0 0 0 0 536 8 Vessel Buffer Prep / Hold 25 0 40 0.2 0.4 0 0 0 0 198 8 Vessel Buffer Prep / Hold 25 0 40 0.2 0.4 0 0 0 0 198 9 Vessel Buffer Prep / Hold 1,500 0 155 0.2 0.4 0 0 0 0 773 8 Vessel Buffer Prep / Hold 25 0 40 0.2 0.4 0 0 0 0 198 10 Vessel Buffer Prep / Hold 200 0 79 0.2 0.4 0 0 0 0 395 9 Vessel Buffer Prep / Hold 500 0 107 0.2 0.4 0 0 0 0 536 10 Vessel Buffer Prep / Hold 200 0 79 0.2 0.4 0 0 0 0 395 9 Vessel Buffer Prep / Hold 500 0 107 0.2 0.4 0 0 0 0 536 10 Vessel Buffer Prep / Hold 200 0 79 0.2 0.4 0 0 0 0 395 9 Vessel Buffer Prep / Hold 500 0 107 0.2 0.4 0 0 0 0 536 9 Vessel Buffer Prep / Hold 500 0 107 0.2 0.4 0 0 0 0 536 10 Vessel Buffer Prep / Hold 500 0 107 0.2 0.4 0 0 0 0 536 9 Vessel Buffer Prep / Hold 500 0 107 0.2 0.4 0 0 0 0 536 11 Vessel Buffer Prep / Hold 25 0 40 0.2 0.4 0 0 0 0 198 9 Vessel Buffer Prep / Hold 500 0 107 0.2 0.4 0 0 0 0 536 12 Vessel Buffer Prep / Hold 50 0 50 0.2 0.4 0 0 0 0 249 9 Vessel Buffer Prep / Hold 1,500 0 155 0.2 0.4 0 0 0 0 773 12 Vessel Buffer Prep / Hold 500 0 107 0.2 0.4 0 0 0 0 536 9 Vessel Buffer Prep / Hold 1,500 0 155 0.2 0.4 0 0 0 0 773 10 Vessel Buffer Prep / Hold 200 0 79 0.2 0.4 0 0 0 0 395 Hold bag cleaning list 10 Vessel Buffer Prep / Hold 200 0 79 0.2 0.4 0 0 0 0 395 10 Vessel Buffer Prep / Hold 200 0 79 0.2 0.4 0 0 0 0 395 10 Vessel Buffer Prep / Hold 200 0 79 0.2 0.4 0 0 0 0 395 10 Vessel Buffer Prep / Hold 200 0 79 0.2 0.4 0 0 0 0 395 A significant reduction in cleaning 10 Vessel Buffer Prep / Hold 200 0 79 0.2 0.4 0 0 0 0 395 10 Vessel Buffer Prep / Hold 500 0 107 0.2 0.4 0 0 0 0 536 10 Vessel Buffer Prep / Hold 500 0 107 0.2 0.4 0 0 0 0 536 operations 11 Vessel Buffer Prep / Hold 25 0 40 0.2 0.4 0 0 0 0 198 11 Vessel Buffer Prep / Hold 25 0 40 0.2 0.4 0 0 0 0 198 12 Vessel Buffer Prep / Hold 50 0 50 0.2 0.4 0 0 0 0 249 12 Vessel Buffer Prep / Hold 50 0 50 0.2 0.4 0 0 0 0 249 12 Vessel Buffer Prep / Hold 500 0 107 0.2 0.4 0 0 0 0 536 12 Vessel Buffer Prep / Hold 500 0 107 0.2 0.4 0 0 0 0 536 Stainless cleaning list © BioPharm Services Ltd CONFIDENTIAL
  • 27.
    Impact of Disposableson Water At this point stainless steel starts to Using multiple bags take over from disposables based on instead of larger vessels vessel size Maximises water saving © BioPharm Services Ltd CONFIDENTIAL
  • 28.
    Why SS majority of water used for cleaning At 1000L 90% used for CIP Disposables significantly reduce water load A 10 fold reduction at 1,000L scale 3 fold at 10,000L scale (best case) which may not be practical © BioPharm Services Ltd CONFIDENTIAL
  • 29.
    Scenario Analysis –Rapid Evaluation of Options Scenario Definition Base Hold Bio Liner Mixer Membrane Single-Use Systems Bioreactors (up to 2000L) No No Yes No No No Media Preparation (up to 2000L) No No No No No No Buffer Preparation (up to 2000L) No No No Yes Yes No Type of Buffer Prep System Liner Liner Liner Liner Bag System Liner Media and Buffer Hold (up to 3000L) No Yes No No No No Intermediate Product Hold (up to 2000L) No Yes No No No No Use Stainless Steel above Threshold No No No No No No Threshold Volume 2000 2000 2000 2000 2000 2000 Membrane Adsorber for Flowthrough No No No No No Yes Size of MA Capsule 10 10 10 10 10 10 Batches per year 90 90 94 90 90 90 Throughput (kg or doses per year) 185 185 193 185 185 185 Total capital (US$ M) 60.6 43.3 46.2 56.0 57.1 56.7 0.0% -28.6% -23.7% -7.6% -5.7% -6.4% Cost per gram (US$) 174.46 144.28 153.80 168.02 172.61 168.97 0.0% -17.3% -11.8% -3.7% -1.1% -3.1% Capital Charge 68.53 48.93 50.07 63.35 64.62 64.12 0.0% -28.6% -26.9% -7.6% -5.7% -6.4% Materials 26.47 25.55 26.31 26.47 26.47 26.32 0.0% -3.5% -0.6% 0.0% 0.0% -0.5% Consumables 20.55 28.59 27.06 20.89 23.89 21.12 0.0% 39.1% 31.7% 1.7% 16.3% 2.8% Labour 40.24 28.43 36.33 40.06 40.06 39.85 0.0% -29.4% -9.7% -0.5% -0.5% -1.0% Others 18.67 12.78 14.04 17.26 17.57 17.55 0.0% -31.6% -24.8% -7.5% -5.9% -6.0% © BioPharm Services Ltd CONFIDENTIAL
  • 30.
  • 31.
    Hold Bag Pricing Hold Bag Pricing Price $/g ∆ CoG 25% 141.52 -1.9% 50% 142.44 -1.3% 75% 143.36 -0.6% 100% 144.28 0.0% 125% 145.20 0.6% 150% 146.12 1.3% 175% 147.04 1.9% 200% 147.96 2.6% 225% 148.88 3.2% 250% 149.80 3.8% © BioPharm Services Ltd CONFIDENTIAL
  • 32.
    Bioreactor Bag Pricing Bioreactor Bag Pricing Price $/g ∆ CoG 25% 148.92 -3.2% 50% 150.55 -2.1% 75% 152.17 -1.1% 100% 153.80 0.0% 125% 155.43 1.1% 150% 157.06 2.1% 175% 158.69 3.2% 200% 160.32 4.2% 225% 161.94 5.3% 250% 163.57 6.4% © BioPharm Services Ltd CONFIDENTIAL
  • 33.
    Bioreactor Hardware Pricing Bioreactor System Pricing Price $/g ∆ CoG 25% 138.22 -10.1% 50% 143.42 -6.8% 75% 148.61 -3.4% 100% 153.80 0.0% 125% 158.99 3.4% 150% 164.19 6.8% 175% 169.38 10.1% 200% 174.57 13.5% 225% 179.77 16.9% 250% 184.96 20.3% © BioPharm Services Ltd CONFIDENTIAL
  • 34.
  • 35.
    Conclusions To drive out cost in biologics manufacturing Many challenges remain The earlier in development the better Carefully evaluate the technologies It is important to understand the costs: Remove opinion its not always obvious Provide insight – understand the drivers Reduce risk Cost Modelling Provides insight Helps make informed decisions Single Use Systems We have demonstrated that they have a significant role This is a function of price, scale and process Process cost modelling is important to support targeted cost effective applications © BioPharm Services Ltd CONFIDENTIAL