DAY ONE

07.45 – 08.30

REGISTRATION

08.30 – 08.40

WELCOME & CHAIRPERSON’S OPENING REMARKS FOR DAY ONE

Dr. Uwe Gottshalk, CSO, Lonza

08.40 – 09.15

The CMC Challenges of Innovative and Breakthrough Biological Therapies

  • How Janssen CMC adapted to address a breakthrough program
  • CMC process scaling up & technology transfer
  • Specifications & regulatory filing with limited time
  • New modalities are often coupled with breakthrough products and the future is now with more to come!

Gene Schaefer, Senior Director, API Large Molecule PDMS, Janssen

09.15 – 09.50

The Next Frontier in Biopharmaceutical Development – Cross-Functional Workflows to Maximize Speed and Therapeutic Performance of Novel Biotherapeutics

  • New development strategies addressing early key performance parameters bringing together discovery and development
  • Define right at the outset a ‘broad’ quality target product profile that includes key aspects linked to the performance of a therapeutic agent in the clinic and for an specific patient population
  • Implementation of early de-risking methodologies and more holistic design strategies to reduce clinical failure and accelerate clinical development
  • Alternatives to traditional ‘funnel-like’ therapeutic development to both maximize success and reduce investment

Jesús Zurdo, Sr. Director Strategic Innovation, Lonza

09.50 – 10.40

COFFEE BREAK & MEETINGS

Downstream Processing

Chaired by Dr. Uwe Gottshalk, CSO, Lonza

Quality

Chaired by  Dr. Alessandro Butte, Group Leader, ETH Zurich

10.40 – 11.15

Continuous BioProcessing and Downstream Process Development Challenges for Non-Platform Biologics

  • Platform v. Non-Platform Considerations
  • Development Cycles and Facility Fit Concerns
  • Technology Gaps in Scale-up/Scale-down Considerations
  • Feasibility v. Implementation
  • Impact on Product Quality

Engin Ayturk, Senior Manager – Technical Development, Biogen

10.40 – 11.15
QbD and Process Validation (PV) Strategies to Accelerate Product Launch

  • QbD and PV, time & resource intensive, often determine critical path for product launch from a manufacturing site
  • Minimize critical path by establishing QbD and PV strategies, which enable “first time right” concept and build upon experience gained for each launch
  • Optimize the QbD and PV workflow for such launch center of excellence by adopting standard work and family approach

Naveen Pathak, Director, Process Development, Shire

11.20 – 11.50
The SMART Factory: End-to-end, Modular Automation for Multiple Processing Platforms

  • Single-use technology application and deployment
  • Modular automation platforms
  • Integrated solutions
  • Manufacturing execution system optimization

 

11.50 – 12.20

Innovations Drive Changes in Antibody Purification Platforms

  • Recent mAb upstream developments puts increased pressure on downstream purification
  • New innovations create opportunities for increased productivity and bioburden control
  • Considerations when choosing and implementing emerging antibody purification platforms
  • Potential future states of antibody purification platforms

 

 

12.20 – 12.50

Development of a Novel Risk and Science Based Approach to Single Use System Integrity Assurance

  • Requirements for integrity assurance of single use systems
  • The influence of process and use conditions on critical leak size
  • Correlation of defect size with liquid egress and microbial ingress
  • Quantitative risk assessment and reduction of Single Use Systems
  • Development of integrity test methods for single use systems

 

11.20 – 12.50

Prearranged one to one meetings on topics of your choice including:

  • Downstream/Upstream Process Technology Platforms
  • Specialised cell culture media
  • Single-use & Disposable Technologies
  • Smart Manufacturing Technologies – Technology Transfer
  • Facility Management & Integration
  • Capacity & Facility Design
  • Multi product facilities
  • Energy & Operational Efficiency
  • Lean/Transformational Change – Operational Excellence
  • Continuous Improvement Manufacturing/Processing
  • PAT & MES, Automation and Process Control Excellence
  • QbD
  • Quality Assurance & Quality Systems
  • Regulation – Rapid Release Testing
  • Inward Investment/Foreign Investment
  • cGMP – Contract/External Manufacturing Services
  • Biogenerics/Biobetters
  • Personalised Medicines
  • Cell & Gene Therapy
  • Fill and finish
  • Cold chain

12.50 – 13.40

NETWORKING LUNCH

Downstream Processing

Chaired by Dr. Uwe Gottshalk, CSO, Lonza

13.40 – 14.15
Downstream Development and Scale-up Challenges for High-Titer Cell Culture Processes

  • Throughout improvement for downstream unit operations
  • Minimal in-process pool volume and load adjustment/preparation
  • Robust impurity clearance and risk-based development strategies
  • Manufacturing facility fit and process development considerations
  • Scale-dependent challenges and model-assisted solutions

Xuankuo Xu, Group Leader, Principal Scientist, Bristol-Myers Squibb

Upstream Processing

Chaired by Dr. Alessandro Butte, Group Leader, ETH Zurich

13.40 – 14.15

Data Science Enabled Stage 1 Validation

  • Process Characterization
  • Scale down model Qualification
  • Stage 1 Validation
  • Justification of Normal Operating Ranges
  • Integrated process modelling
  • Data Science Workflows

Prof. Dr. Christoph Herwig, Head Biochemical Engineering, TU WIEN

14.20 – 14.55

Strategies for Enhancing Manufacturing Efficiency & Excellence while Saving Time and Money

  • Utilize multiple levers (often not all available) to drive efficiency, increase flexibility and reduce costs (process design, raw material selection, facility design, and process implementation)
  • How using certain levers may increase complexity and incur costs, such as regulatory complexity?
  • Experiences gained, lessons learned and strategies to reduce process transfer timelines and costs

Stephen Hohwald, Group Leader & Senior Engineer, Genentech

14.20 – 14.55

Continuous and Personalized BioProcesses Utilizing Single Use Technologies

  • Increased utilization of single use technology is making personalized bioprocess possible but continuous
    bioprocess incompatible
  • Which strategies to bring leading industrial trends together? Selection of raw materials, modification of
    product properties, reduction of the number of buffers, processes simpification, and automation
  • Case studies – Rapid production of tox materials and a single pass purification from harvest to DS/DP

Ping Y. Huang, Associate Director II, BioProcess CMC Biologics, OED, Abbvie

15.00 – 15.35

Continuous Processes for Antibody-Drug Conjugate Manufacturing

  • Continuous conjugation processes utilizing flow reactors are capable of generating ADCs with identical product quality to conventional batch processes
  • Space-time yield optimization of continuous conjugation processes can maximize product output while minimizing equipment footprint and potent compound containment requirements.
  • Single-pass tangential flow filtration enables continuous ADC purification and formulation
  • In-line diafiltration SPTFF demonstrates robust purification capacity of ADCs.

Daniel Milano, Senior Engineer, Conjugation Process Development, Immunogen

15.00 – 15.35

Scale-Up and Scale-down Considerations for 2000L Single Use Bioreactors

  • Case studies of scale-up from bench-top to 500L and 2000L XDR Single Use bioreactors
  • Development of qualified Scale Down Model (SDM) parameters
  • kLa mapping and Computation Fluid Dynamics (CFD) modelling of these reactor types
  • CFD and/or kLa mapping for an improved platform SDM, and results from testing the proposed conditions
  • Usefulness of CFD modelling in comparison to kLa mapping and standard scaling parameters

Kathryn Aron, Senior Scientist II, Upstream Process Development, Bristol-Myers Squibb

15.35 – 16.25

COFFEE BREAK & MEETINGS

16.25 -16.55

Raman Spectroscopy for In-Line Process Control of Bioprocesses

  • In situ Raman spectroscopy is well-suited for a host of bioprocess applications.
  • Raman spectra provide chemical and physical information that can be used for multi-attribute measurements from a single probe
  • Raman spectroscopy enables simultaneous monitoring of multiple cellular biochemistry parameters and Ramanbased feedback control for critical process parameters.
  • Industry applications and technology advances of Raman for bioprocessing

 

16.55 – 17.25

Bulk Filling and Shipping Solutions

  • Single-Use Filter and Dispense System
  • Automated solution
  • Fully Contained filling
  • Standard solution
  • Fill Bottles or Bags

 

15.35 – 17.25

Prearranged one to one meetings on topics of your choice including:

  • Downstream/Upstream Process Technology Platforms
  • Specialised cell culture media
  • Single-use & Disposable Technologies
  • Smart Manufacturing Technologies – Technology Transfer
  • Facility Management & Integration
  • Capacity & Facility Design
  • Multi product facilities
  • Energy & Operational Efficiency
  • Lean/Transformational Change – Operational Excellence
  • Continuous Improvement Manufacturing/Processing
  • PAT & MES, Automation and Process Control Excellence
  • QbD
  • Quality Assurance & Quality Systems
  • Regulation – Rapid Release Testing
  • Inward Investment/Foreign Investment
  • cGMP – Contract/External Manufacturing Services
  • Biogenerics/Biobetters
  • Personalised Medicines
  • Cell & Gene Therapy
  • Fill and finish
  • Cold chain

17.30 – 18.10

Panel Discussion: Current Challenges in Bioprocesses Development

  • Upstream perfusion vs conventional batch processing – Overcoming challenges with process operational complexity contamination risks, characterization time and process development control
  • With recent downstream advances, why is adoption and integration into actual bioprocessing still slow?
  • How to overcome inability to integrate related manufacturing systems with continuous bioprocessing?
  • Current challenges to bioprocessing modelling and understanding of implications of changes in scale

Dr. Uwe Gottshalk, CSO, Lonza

Norbert Schuelke, Senior Director, Downstream Process Development, Takeda Pharmaceuticals International

Prof. Dr. Christoph Herwig, Head Biochemical Engineering, TU WIEN

Gene Schaefer, Senior Director, API Large Molecule PDMS, Janssen

18.10

CHAIRPERSON’S CLOSING REMARKS AND END OF DAY ONE

18.15

COCKTAIL RECEPTION

DAY TWO

08.30 – 08.40

CHAIRPERSON’S OPENING REMARKS FOR DAY TWO AND SUMMARY OF DAY ONE

Dr. Uwe Gottshalk, CSO, Lonza

08.40 – 09.15

Modern Manufacturing Technologies as the Key for Success in Cell and Gene Therapy

  • Emerging global trends in advanced manufacturing
  • The impact of new developments and their potential to deliver more cost effective processes
  • Learning from the success of biotech drugs and production concepts
  • Meeting volume and quality demands in emerging manufacturing areas
  • Paving the way for personalized treatment options

Dr. Uwe Gottschalk, CSO, Lonza

09.15 – 09.50

End-to-End Integrated Processing Using Continuous/Batch Hybrid Systems and Raman Spectroscopy PAT

  • Integrating upstream and downstream operations
  • Results from pilot scale operations and options for scaling up
  • Pathways to implementation
  • In-line monitoring of IgG by Raman spectroscopy multivariate chemometrics model

Dr. Peter Slade, Senior Principal Scientist, Pfizer
Min Zhang, Scientist, Pfizer

09.50 – 10.25

Scientific Information Management and Data Governance in Pharma

  • Why is the Pharma industry considered slow moving in leveraging data effectively, as most studies indicate?
  • Compare the cultural characteristics of pharma and high-tech industry
  • Effectively leverage data as an asset, information solutions need be tailored to meet the industry and company
    cultural characteristics
  • The case for customizing information solutions to fit the cultural and industry characteristic

Bibi Ephraim, Scientific Data Management Lead, Genentech

10.25 – 10.50

COFFEE BREAK & MEETINGS

Biosimilars

Chaired by Dr. Uwe Gottshalk, CSO, Lonza

10.50 – 11.25

Using SPOT™ technology in our CHOBC® platform and our USP modulation toolbox to reduce cost of goods for biosimilar development

      • SPOT™ technology in our CHOBC® platform
      • Upstream process modulation to meet CQAs
      • Costs of Goods reduction
      • Custom bio-assays

Dr. Louis Boon, CSO, Bioceros (Polpharma Group)

Upstream Processing

Chaired by  Dr. Alessandro Butte, Group Leader, ETH Zurich

10.50 – 11.25
Future Challenges in BioPharma – The Role of Big Data and Digitalization Technologies for Drug Manufacturing

      • Which is our vision? The key role of enhanced learning
        and hybrid models
      • What are hybrid models? How to exploit the synergies
        of process knowledge and machine learning to
        enhance process development, monitoring and
        control
      • Examples of use of statistical tools for biosimilar
        development
      • Examples of application of process digitalization
        in biopharma: the case of continuous integrated
        manufacturing of therapeutic proteins
      • Future challenges to the full implementation of
        digitalization – the need an holistic view to process and
        quality management

Dr. Alessandro Butte, Group Leader , ETH Zurich

11.25 – 11.55

Standardization of Single-Use Connections

  • Summarize the type of connections that exist in the market currently.
  • Qualification and testing of connections – What to look for.
  • What are the obstacles and best practices when selecting connections?
  • The differences between tube welding and single-use connectors
  • What standardization could mean for the industry with regard to connectors

 

11.55 – 12.25

Single Use Equipment Integration into a DCS and MES

  • Packaged Unit integration
  • Plug and Play location identification
  • Electronic Batch Record
    – Generation
    – Release by exception

 

12.25 – 12.55

Q-BIOME – a Tool for Probing ‘Microbial Dark Matter’ in Search of ‘Anti-Bacterial Kryptonite’

  • Single-use bioreactors and next-generation bioprocessing control platforms for the biomanufacturing of low-volume, high-value secreted products
  • Biomimetic environments facilitate bioprospecting for novel bioactive molecules through the deregulation of secondary metabolite expression
  • ‘One Strain/Many Compounds’ (OSMAC) approach using multi-operon wild-type or recombinant adherent cell lines supports true ‘Biomanufacturingon-Demand’ capabilities

 

11.25 – 12.55

Prearranged one to one meetings on topics of your choice including:

  • Downstream/Upstream Process Technology Platforms
  • Specialised cell culture media
  • Single-use & Disposable Technologies
  • Smart Manufacturing Technologies – Technology Transfer
  • Facility Management & Integration
  • Capacity & Facility Design
  • Multi product facilities
  • Energy & Operational Efficiency
  • Lean/Transformational Change – Operational Excellence
  • Continuous Improvement Manufacturing/Processing
  • PAT & MES, Automation and Process Control Excellence
  • QbD
  • Quality Assurance & Quality Systems
  • Regulation – Rapid Release Testing
  • Inward Investment/Foreign Investment
  • cGMP – Contract/External Manufacturing Services
  • Biogenerics/Biobetters
  • Personalised Medicines
  • Cell & Gene Therapy
  • Fill and finish
  • Cold chain

12.55 – 13.45

NETWORKING LUNCH

Downstream Processing

Chaired by Dr. Uwe Gottschalk, CSO, Lonza

13.45 – 14.20

Control of Polysobate 80 Degradation During Bioprocessing

  • PS80 degradation impact and root cause
  • Optimization of medium components in upstream cell culture processes to control lipase
  • Applications in downstream processing to remove impurities that can possibly cause PS80 degradation
  • Mitigation of analytical challenges in PS80 degradation measurement during process development

Jie Chen, Senior Scientist, Bristol-Myers Squibb

Upstream Processing

Chaired by Dr. Alessandro Butte, Group Leader, ETH Zurich

13.45 – 14.20
Rapid Implementation of a 1kL SUB: From Pilot Plant to GMP Clinical Material

  • Rapid implementation of a 1kL SUB into our Pilot plant and into our GMP facility in less than a year.
  • Successful transfer of CMC1 processes from 500L to 1kL scale in GMP without engineering runs.
  • 100% success rate in our Flexible GMP facility.

Dominique T. Monteil, Scientist II, Cell Culture, Process Science, Boehringer Ingelheim

14.25 – 15.00

Evaluation of Different Continuous Chromatography Systems for Continuous Capture

  • Integrated and continuous chromatography – Leading tool for transition to continuous biomanufacturing
  • Different available technologies, which differ in configuration and control elements
  • What are their benefits and limitations. Selection of one can be based on requirements and feasibility
  • Comparison of different systems, with feasibility data and operational aspects

Sujit Jain, Sr. Engineer II, Purification Process Development, Shire

14.25 – 15.00

The Need for Speed: Maturing the Tech Transfer Business Processes to Achieve On-time Readiness for
Clinical Drug Substance Manufacture

  • The scope and cadence of clinical tech transfers into the Biogen Large Scale Manufacturing (LSM) Facility (RTP North Carolina)
  • Evaluating the established Tech Transfer business process:
    – Defining the inputs required for successful tech transfer execution
    – Identifying pinch points and stressors
    – Mapping the risk profile
  • A case study of implementing improvements to achieve speed and mitigate manufacturing readiness risks and yield improvement

Carin Gray, Senior Engineer II, Biogen

15.00 – 15.15

COFFEE BREAK

15.15 – 15.50

Pre-competitive Collaboration in Biomanufacturing

  • Overview of the activities of the MIT Consortium on Adventitious Agent Contamination in Biomanufacturing
  • Innovation in biomanufacturing at MIT
  • New platforms for education and training in biomanufacturing at MIT

Dr. Stacy L. Springs, Senior Director of Programs, MIT Center for Biomedical Innovation and Executive Director, BioMAN and CAACB

 

15.50

CHAIRPERSON’S CLOSING REMARKS

16.00

CLOSE

Please note: Agenda and speakers are subject to change.