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Biomanufacturing Technology Roadmap

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Biomanufacturing Technology Roadmap ©BioPhorum Operations Group Ltd OVERVIEW BIOMANUFACTURING TECHNOLOGY ROADMAP OVERVIEW BPOG Technology Roadmap 1 ©BioPhorum Operations Group Ltd OVERVIEW Acknowledgments The following member company participants are acknowledged for their efforts and contributions in the production of this roadmap document. (Overview section authors highlighted by *.) Abbvie Janssen PM Group Derek Sawyer Patrick Sheehy Andy Rayner Li Malmberg (formerly) Ranjit Thakur* Roche Natarajan Ramasubramanyan Stefan Merkle* Oliver Stauch* Timo Simmen Asahi Kasei Bioprocess Paul Bezy Kimo Sanderson Kaiser Optical Systems (formerly) Tina Larson* David Strachan AstraZeneca Sanofi Rick Lu* Lonza Beate Mueller-Tiemann Rajesh Beri* Thomas Sauer Bayer Edgar Sur M+W Group Sartorius Stedim Ingmar Dorn David Estapé Lars Boettcher Janet Wendorf Merck KGaA, Shire Joerg Heidrich Darmstadt, Germany (formerly) Alan Glazer Thomas Daszkowski Jonathan Souquet* (formerly) Bert Frohlich* Biogen David Beattie Chun Zhang Eliana Clark* (formerly) Joerg Ahlgrimm Merck & Co., Inc., Phil McDuff Kenilworth, NJ, USA. Takeda CRB David Pollard Palani Palaniappan Kim Nelson Wayne Froland Thermo Fisher Scientific (formerly) Beth Junker* Emerson Craig Smith Robert Lenich NNE UCB Morten Munk Fujifilm Diosynth Biotechnologies John O’Hara Stewart McNaull* Novasep BioPhorum Jean-Luc Beulay G-CON Operations Group Maik Jornitz Pall Steve Jones* Hélène Pora Paul Ilott* GE Healthcare Life Sciences Linda Wilson* Jonas Astrom Pfizer Bob Brooks Joris Smets* GSK Clare Simpson* Paul McCormac* Charles Heffernan* Jonathan Dakin Will Waterfield David Paolella Justin John (formerly) Louise Duffy Publication Team ImmunoGen, Inc. Les Pickford Sandra Poole Karen Kilbride Thomas Ryll* Steve Pitt The steering committee would like to thank the following non-member participants for their contribution to the roadmap meetings: Alexion AMBIC, John Hopkins University MIT Al Boyle Michael Betenbaugh Charles Cooney Chris Love Biopharm Services BioProNet Alan Calleja* Alan Dickson NIST Andrew Sinclair Michael Tarlov BPTC Eli Lilly Tom Ransohoff UCL Todd Winge Gary Gilleskie Dan Bracewell Novavax Centre for Process University of Delaware, Tim Hahn Innovation (CPI) NIIMBL Richard Alldread Kelvin Lee A*STAR (Agency for Science, Technology & Research) ETH Zurich Andre Choo Massimo Morbidelli May Win Naing BPOG Technology Roadmap 2 ©BioPhorum Operations Group Ltd OVERVIEW Contents 1 Introduction...........................................................................................................................................................................................................5 1.1 Current state of the industry: the case for change ............................................................................................................................................5 1.2 Objectives ...........................................................................................................................................................................................................................5 1.3 Scope .....................................................................................................................................................................................................................................5 1.4 Roadmap participants ....................................................................................................................................................................................................6 1.5 The biopharmaceutical roadmap methodology ..................................................................................................................................................6 2 Market trends ......................................................................................................................................................................................................8 2.1 Market growth ..................................................................................................................................................................................................................8 2.2 New product classes .......................................................................................................................................................................................................9 2.3 Uncertainty of product success and sales ...........................................................................................................................................................11 2.4 Cost pressures ...............................................................................................................................................................................................................12 3 Business drivers and metrics ......................................................................................................................................................................... 13 3.1 Facility flexibility ..........................................................................................................................................................................................................14 3.2 Speed ..................................................................................................................................................................................................................................14 3.3 Quality ...............................................................................................................................................................................................................................15 3.4 Cost .....................................................................................................................................................................................................................................16 3.5 Metrics ...............................................................................................................................................................................................................................17 4 Biomanufacturing scenarios .......................................................................................................................................................................... 19 4.1 Drug substance scenarios ..........................................................................................................................................................................................19 4.1.1 Scenario 1: Large-scale stainless steel fed batch .............................................................................................................................22 4.1.2 Scenario 2: Intermediate-scale single-use perfusion .....................................................................................................................23 4.1.3 Scenario 3: Intermediate-scale multiproduct single-use fed batch .........................................................................................24 4.1.4 Scenario 4: Small-scale <500L portable facility ................................................................................................................................24 4.1.5 Scenario 5: Small-scale <50L for personalized medicines ............................................................................................................25 4.2 Drug product scenarios ..................................................................................................................................................................................................26 4.2.1 Introduction .....................................................................................................................................................................................................26 4.2.2 Low-volume drug product manufacturing scenario........................................................................................................................26 4.2.3 High-volume drug product manufacturing scenario ......................................................................................................................27 4.2.4 Initial considerations to deliver 10-year targets ..............................................................................................................................28 5 Regulatory strategy ......................................................................................................................................................................................... 29 5.1 Introduction .....................................................................................................................................................................................................................29 5.2 Scope ..................................................................................................................................................................................................................................30 5.3 Regulatory needs, challenges and potential solutions ...................................................................................................................................31 5.3.1 Needs and challenges ..................................................................................................................................................................................31 5.3.2
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