Pharma&Biotech. Increasing Competitiveness of Legacy Stainless Steel Facilities in the Era of High Titer Processes and Single Use Technologies

Transcription

1 Pharma&Biotech Increasing Competitiveness of Legacy Stainless Steel Facilities in the Era of High Titer Processes and Single Use Technologies Elise-marie R. Beri / Lonza Seng Biologics /, Basel Inc / 10. / IFPAC Mai 2012 Arlington VA / 25 Jan 16

2 Forward-Looking Statements Certain matters discussed in this presentation may constitute forward-looking statements. These statements are based on current expectations and estimates of Lonza Group Ltd, although Lonza Group Ltd can give no assurance that these expectations and estimates will be achieved. Investors are cautioned that all forward-looking statements involve risks and uncertainty and are qualified in their entirety. The actual results may differ materially in the future from the forward-looking statements included in this presentation due to various factors. Furthermore, except as otherwise required by law, Lonza Group Ltd disclaims any intention or obligation to update the statements contained in this presentation. 2

3 Abstract There are an increasing number of reports in Biopharma industry Literature touting the numerous advantages of Fully Disposable Biologics Manufacturing Facilities over traditional Stainless Steel Facilities. This talk will review the published studies comparing the Capital and Operating costs of a Fully Disposable Biologics Manufacturing Facility with a Traditional Stainless Steel Manufacturing Facility and outline the approaches that can be taken in order to increase the Competitiveness of Legacy Stainless Steel Facilities. 3

4 Lonza s Global Pharma & Biotech Footprint Portsmouth, NH (2003) Mammalian Cell Culture 3 x 5,000L, 4 x 20,000L cgmp Walkersville Portsmouth Verviers, BE Slough, UK Braine, BE Porriño, SP Slough, UK (1980 s 90 s) Mammalian Cell Culture 200L to 2,000L cgmp SS & SUB Process R&D Services Kouřim, CZ Visp, CH Houston Porriño Spain (2008) Mammalian Cell Culture 4 x 10,000L cgmp Nansha Lonza ,000L of SS Capacity 3 x 1000L SUB (Slough) Singapore Tuas Singapore (2010) Mammalian Cell Culture 200L to 20,000L cgmp Process R&D Services Cell Therapy View our 360 virtual tours at

5 Presentation Overview Key drivers for single use facilities 1990 s Single use (SU) and stainless steel (SS) facilities Advantages and disadvantages Cost of goods comparison 2000 s Optimize legacy SS facility operation 4 x 20K SU facilities: Replacement or complementary 2020 s SU or SS? 5

6 Lonza Press Releases, New manufacturing line to be constructed at Lonza s existing Portsmouth, NH (USA) plant Large-scale, manufacturing line will be operational by the end of 2017 Enables Alexion to add dedicated product supply for 10 years Lonza adds two 1000L single-use bioreactor systems to its current mammalian manufacturing capacity The additional bioreactors will help meet the increasing demand for flexible manufacturing capacity for clinical development supply 6

7 New Facilities Shire's single-use MA plant receives US FDA approval to make VPRIV By Dan Stanton, 18-Feb-2014 Amgen launches $200m biomanufacturing facility in Singapore By Zachary Brennan, 21-Nov-2014 Amgen has completed construction of its first $200m next-gen biomanufacturing facility in Singapore, which is outfitted with single-use technology to allow for greater flexibility. BMS highlights shift to biologics with plans for $900m plant in Ireland By Dan Stanton, 14-Nov-2014 Bristol-Myers Squibb has announced plans to build a biologics facility in Ireland, eight months after winding down a small molecule API plant at the same site Cumbria biopharma plant to create 500 jobs and business ops says GSK By Gareth MacDonald, 12-Feb-2014 GSK has unveiled designs for the 350m ($587m) biomanufacturing plant it intends to build in UK and confirmed that construction will start early next year Source: 7

8 Titer Range, g/l Market Trends Trend is towards lower volume products and higher titers High Low Year Source: CMO Biologics: Market, Competition and Strategy, Lonza, October 2013 High titers and lower annual demand Biosimilars in this category due to market fragmentation Lower production bioreactor size can meet anticipated annual demand for multiple future products 8

9 Technology Trends Increasing availability of Single Use Technologies Single use bioreactors Single use mixers Pre-packed columns All technologies are shown for illustrative purposes Membrane adsorbers Bioprocess bags and containers Disposable systems for VI, VRF, TFF Images provided courtesy of EMD Millipore Corporation and GE LifeSciences 9

10 SUT Facilities Advantages Disadvantages Lower CAPEX & footprint More parts to manage Lower build time Reduced validation effort Possibility of scaleout Increased amount of solid waste Lower degree of automation Lower fixed costs & OPEX Cannot exploit economy of scale No CIP / SIP Reduced maintenance Reduced change over Lower utility usage Other Increased flexibility Less complex to operate Additional Reference: Aspen Brook Consulting, 7 th Annual Single Use Market Survey 10

11 Let the $$$$ Speak Howard Levine ( Capital cost Cost per gram SU (2K) vs SS (2K) SU facility ~ 25% lower SU facility ~ 19% lower COGS Andrew Sinclair ( Integrated_Final_V02.pdf) SU (2K) vs SS (2K) SU (2K) vs SS (15K)* Cost per gram SU facility ~ 21% lower SS facility ~ 49% lower * Multiple products with moderate annual demand at 15K with 100% utilization Modeling indicates 2K SU facility is cost competitive with SS at 2K However SS (15K) offers significant economy of scale 11

12 Legacy SS Facilities Advantages Disadvantages Fully or partially depreciated High fixed costs Large scale equipment Designed for lower titer range Economy of scale Old or obsolete technologies Less consumables compared to SU Introducing new technologies is a higher burden Operational experience More amenable for automation Multi-products / Majority commercially approved Increasing Efficiency of Legacy SS Facilities is NECESSARY 12

13 Legacy SS plants - Opportunities Operational Excellence Increase facility capability Implement innovative technologies Paperless, automation, Robotics All technologies are shown for illustrative purposes 13

14 # Batches Increase Facility Capability Handle higher titers Seed bioreactors as production bioreactors Higher product volumes in DSP Jeff Robinson, Lonza, IBC, 2011 Integrating disposable mixing systems Campaign durations Number Batches per Year Reduce facility bottlenecks +25% Optimize product mix & campaign length +15% at each site Reduce changeover (CO) time, # changeovers CO time (+ Debottlenecking) 14

15 Next Generation Technologies There are many new technologies There are many new technologies!!! Prioritize! Prioritize!! Prioritize!!! 15

16 Prioritization System Economic value Net return / cost of implementation Higher the ratio, higher the score Batch Cost Drivers Impact Replacing obsolete technologies Improving process yield Facility Time Direct Labor Raw Materials (ex Resins) Changeover Other Ease of implementation Like for like Regulatory changes 16

17 Harmonized and Simplified Technology Evaluation & Implementation Process Idea Planning Feasibility Proof of Concept Development Qualification & Validation Implementation Extension 17

18 Implementation of Laboratory Execution System (LES) Increasing use of automation and data integration tools in process development, manufacturing, and QC. ERP Systems, Document Management Systems, LIMS PD Manufacturing QC ELN ebr LES Lab Instruments, DCS, Lab Software 18

19 Real Time Process Monitoring, Reporting, Analysis And Control CURRENT STATE FUTURE STATE Offline data analysis SPC, MVA, modeling,. Retrospective Prevent future issues FUTURE VISION Real time monitoring Inline probes, SPC, MVA, modeling, dashboards Prospective Prevent current issues Improve future production Dashboards BENEFITS Increased process Knowledge Online advisory Online control Improved operations Intelligent Manufacturing 19

20 Summary Multiple efforts across Lonza Debottlenecking Throughput improvement Operational excellence Next generation technologies Automation Combined efforts synergistic benefits Increase competitiveness of legacy SS facilities New Facilities, SU 66,000 L SU Facilities High titer products with low annual demand Clinical Production 590,000 L SS is 9x SUT 20

21 Acknowledgements Jeff O Connor Trent Johnson Michael Moedler Joanna Ferrero Jessica Jean Diego Schmidhalter Una de Wit Henriette Schneider Maribeth Janke 21