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Changing the Paradigm: How Biogen tech transfers processes into our disposable manufacturing facility Marcelo Anderson Manufacturing Sciences Biogen.

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Presentation on theme: "Changing the Paradigm: How Biogen tech transfers processes into our disposable manufacturing facility Marcelo Anderson Manufacturing Sciences Biogen."— Presentation transcript:

1 Changing the Paradigm: How Biogen tech transfers processes into our disposable manufacturing facility Marcelo Anderson Manufacturing Sciences Biogen

2 Agenda  Technology Transfer Defined  Scope & Thesis  Technology  Business Processes  Technology Transfer  Possible Next Steps  Questions Disposable Equipment Flexible Facility Understand Your Asset Facility Scheduling Team Structure Streamlined Processes Simplify Information Decision Making

3 Process Technology Transfer  Transfer all the knowledge needed to perform a given biotech process from a Transferring Site to a Receiving Site -ISPE 10 September 2009, Herwig Kapeller, Novartis Pharmaceuticals Corp.  Also includes - Responsible for the successful production, disposition, stability and product comparability from transferring site to receiving site. -Biogen Global Technology Transfer

4 Scope & Thesis  Scope – early clinical (FIH/I/II) production of recombinant biotherapeutics with mammalian cells  Thesis – the right technology+ business systems+ Tech Transfer allows for transformational performance -> >75% improvement

5 Technologies: Strategy 5  Fully compliant for phase  Keep it simple  Keep it flexible  Make equipment identical to pilot plant  Innovate – within and piloting  Make it differentiated -Capability -Capacity

6 Technologies: Applied Disposable Equipment Disposable Adaptable - on and off platform Closed Flexible Facility Stand alone Small footprint Innovation space Clinical: Pre FIH, Phases 1 to 2 Understand Your Asset Understand advantages Differentiate Innovate

7 Understand Your Asset FVM vs SSM (Titer – 4 g/L) Breakeven point ~ 8 kg

8 Disposable Equipment A.Shukla et Al (2012), Vertical Integration of Disposables in Biopharmaceutical Drug Substance Manufacturing. BioProcess International 10(6) 1,000L Detergent Viral Inactivation Low pH Viral Inactivation

9 Flexible Facility (FVM)  Four clinical campaigns completed successfully demonstrating proof of concept  ISPE Facility of the Year Award ,000 square foot facility in RTP utilizing upstream and downstream single-use technologies -Closed process from inoculum prep through final drug substance bagging. -Approach designed for speed and adaptability which enable transformational improvement

10 Business System: Strategy 10 Change Control Rigidity Commercial cGMP Development Pilot Plant Tox Material Traditional SS Clinical ? FVM  Fully compliant  Keep it simple  Use original sources of data  Innovate FVM

11 Business Systems: Applied Facility Approach and Scheduling Adaptability/$ to failure On demand production Organized like pilot plant Team Structure Self directed team & independent Commitment/expertise on the floor Increases equipment flexibility Streamlined Processes Standard document templates Alignment between groups Optimized tech transfers

12 FVM Facility Thought Process and Scheduling R to D Transition IND Filing IMPD’s Q1Q2Q3Q4Q5Q6 Process Development Raw Material Procurement/ TT Bulk Mfg DS Release DP Fill DP Release Stability Pack / Release Tox Study + FIH Protocol Tox-pilot F/R Non-GMP GMP Industry Standard: Approximate Timeline from Cell Line Selection to IND: months IND FilingIMPD’s Q1Q2Q3Q4Q5Q6 Process Dev RM Procurement Bulk Mfg DS / DP Release Stability Tox Study Pack / Release DP Fill GMP FVM Thinking: Approximate Timeline from Cell Line Selection to IND: 10 months Non-GMP Bulk Mfg DP Fill FIH Protocol DS / DP Release Pack / Release

13 FVM Team Structure -Integrated Operations Unit (IOU) Common Goal Rapid Supply of Clinical Material Leadership Drive Vision Develop Business Quality Compliance QA Sys. Systems Documentation Knowledge Management Operations Production Concept Deployment Planning Schedule Inventory Technical Process Expertise Single Use Sys. RTP MFG 13 Rotation All members co-located on the production floor Diverse skillset Senior Mfg. Associates Engineers Scientists Junior staff with high potential Team is empowered to make decisions / create new business processes On the Floor

14 Team Structure - Applied MFG MS TD Ex. Brx Inoculation & BPR Review QA Tech (MS) Systems (Doc) MFG Ex. BPR Issuance & Review Rotation On-the-floor Issuance Local Inventory Real-Time Transactions Production BPR Review Hours Real World Examples – Not Staged

15 15 FROMTO Conventional tech transfer Seamless knowledge transfer “Line function centric” approach Nimble “product centric” approach Multiple hand-offsMinimal hand-offs Application of commercial- centric systems for all programs Adopting flexible/simplified system for clinical programs a new operating model, where an accelerated approach for early phase drug development is realized. Our clinical supply chain is optimized so that cGMP compliance lives comfortably alongside the flexibility required to enable rapid delivery of clinical supplies. It is a model that dissolves the existing functional operating boundaries in the transition of clinical programs. Success means, every individual’s contribution increases the opportunity to advance more drug candidates. Tech Transfer Process: Strategy From “ Clinical Supply Transformation New Business Model” September 2011 Kasra Kasraian, Rhonda Sundberg, Steven Doares, Adam Sheriff, Tom Holmes, Ian Rosenblum, Rick Shansky, Andre Walker

16 Tech Transfer: Applied Simplify Focus on the critical / eliminate unnecessary Minimize membership Same equipment throughout Information Centralized information done once Automatic record creation Information ownership clarity & empowerment Decision Making Reframing Risk Transfer decisions / ownership Team of 4

17 Simplify Traditional Transfer  Characterize platform & Process screening  Lab work to manage differences  Confirm at pilot & full scale  Ensure comparability  Rapid deployment  Minimize risk to ensure schedule  Product stability + phase 1/2 material  Typical transfer 12+ months & >$2.5MM  Team – dozen+ FVM Transfer  3L only  Take the risk  FVM is full scale  Nothing to compare to  Minimize deployment  Schedule adjust to success  +Tox  4 weeks & $50K  Team - 4

18 Information Template batch records decouple process description from operational instruction  Minimizes resource burden responsible for documentation development  Minimizes timelines (non-iterative development & independent review process) Template batch records adapt to unpredictably of an early clinical processes  Provide increased flexibility at expense of being less prescriptive  Requires knowledgeable staff to execute (ex. normalized values) 18 PFD Development PFD Approval Record Development Record Approval Record Issuance Process DescriptionRevision Cycle Batch Production Record PFD Record Unit Op Instruction Materials Table Clinical Comments  Source for operational parameters  Empowers staff with process knowledge  Modular, semi-chronological form  Serves as activity log  Flexibility for real-time change

19 Decision Making 19  Empowered team of 4 -Representation -Similar to development  Notes -Communication ease -Empowered for decisions -Readies team for decisions -Need right personalities

20 Summary Disposable Equipment Flexible Facility Understand Your Asset Facility Scheduling Team Structure Streamlined Processes Simplify Information Decision Making

21 Possible Next Steps  Velocity -R to MFG, no passing D -6 month supply chain - +DP/LP -Throughput - Multiple purification areas -Disposable continuous chromatography  Scheduling -On-demand -Disposable buffer concentrates  Simplicity -Replace depth filtration -60cm disposable column

22 Acknowledgements  Rich Guerra  Mark Chen  Shane McCarroll  Chad Cooper  Matt Haines  Chris Antoniou  Jack Kane  Venkatesh Natarajan  Scott Keetch  Matt Westoby  Phil Vilmorin  Devin McCann  Diana Brown  Mike Rogers  Lynn Conley  Sanaa Elouafiq


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