DAY ONE

07.45 – 08.30

Registration

08.30 – 08.40

Welcome & Chairman’s Opening Remarks for Day One

Felix Oehme, VP, Head of Biological Development, Bayer

08.40 – 09.15

Factory of the Future 1 – Technology Innovations to Expedite Global Biologics Development

  • State-of-the-art technology platforms have been established to expedite global biologics development from discovery to commercialization.
  • Technology innovations will be highlighted for improving development efficiencies and reducing timelines from DNA to IND from a typical duration of 18 months to 7-9 months.
  • Technology Innovations also are being used for reducing the manufacturing costs by implementing the next generation continuous bioprocessing solution called WuXiUP with ultra-high productivity.

Weichang Zhou, Ph.D., Senior Vice President, Biologics Development and Manufacturing, Wuxi Biologics

09.15 – 10.00

How to exit a commercial roller bottle process and fix the quality attributes for a complex protein. A joined Up- and Downstream Approach.

  • 2nd Gen Process Development (from roller bottles into bioreactors) for a complex non mab like protein
  • Significant Yield Increase and Cost Reduction
  • Joined Up- and Downstream approach to keep Quality Attributes within commercial range
  • Challenges during Upscale and Lessons Learned

Daniel Fleischanderl, Associate Director Upstream Process Development, Process Development & Technical Services & Dominik Mittergradnegger, Head of Downstream Process Development Austria, Takeda

10.00 – 10.50

COFFEE BREAK & MEETINGS

Downstream Processing

Upstream Processing

10.50 – 11.25

Validation of next gen depth filter technology in a commercial downstream process

  • Current situation
  • Proposed situation
  • Small scale development
  • Upscaling and Large scale validation
  • Conclusion and take home messages

Wesly Vandevelde, DSP Engineer Supervisor, Sanofi Genzyme

10.50 – 11.25

Common denominators of process and life cycle control strategies

  • Capture your process knowledge in Digital Twins
  • Accelerate time to clinic by Digital Twin controlled experimental designs
  • Deploy your knowledge in real time model predictive control architectures enabling continuous manufacturing
  • Identify holistically relevant process parameters and anticipate life cycle variabilities using integrated digital twins

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

11.30 – 12.05
iSKID Continuous Integrated Manufacturing System

  • Biopharma markets are evolving through the duality of precision medicines and novel blockbusters, requiring flexible manufacturing approaches
  • Continuous Manufacturing will complement, and may one day disrupt, established fed batch manufacturing
  • Traditional challenges of continuous perfusion, such as high media volumes, can be overcome
  • Full integration and automation is essential
  • Our platform maximizes robustness and flexibility in multi-product settings

Samet Yildirim,Technology Innovation Manager, Boehringer Ingelheim

11.30 – 12.05

Vaccine development and manufacturing in the era of acceleration and Industry 4.0

  • Significant demand and pressure on vaccine industry prompts faster adoption of new technologies
  • Industry 4.0 presents opportunities in every aspects of the vaccine life cycle
  • Challenges to initiate and sustain transformation for vaccine development and manufacturing
  • A fine balance between acceleration and transformation
  • Case studies on development and implementation

Hao Chen, Head of Cell & Viral Drug Substance, GSK

12.05 – 13.05

One to One Meetings

  • 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
  • Microbial Process Development and Production
  • Lean/Transformational Change – Operational Excellence
  • Continuous Improvement / Manufacturing Processing
  • Process Engineering
  • PAT & MES, Automation and Process Control Excellence
  • QbD
  • Quality Assurance & Quality Systems
  • Regulation – Rapid Release Testing
  • Finance / Inward & Foreign Investment
  • cGMP – Contract, External Manufacturing Services
  • Biogenerics/Biobetters
  • Personalised Medicines
  • Cell & Gene Therapy
  • Fill and finish
  • Cold chain

12.05 – 12.35
Bulk filling: The application of automation and control to the filling process.

  • At the bulk filling stage the product is at its highest cost per ml
  • Losses at this stage have a serious negative impact on the COGS
  • Through automation bulk filling can be simplified, standardised and de-risked
  • Utilising single use technology to protect the patient, the operator and the product.

12.35 – 13.05
Future trends perspectives and insights on biomanufacturing

  • Major market trends, market growth and new modalities
  • Risk factors in biomanufacturing
  • Capacity planning: new approaches and technologies
  • Process intensification

13.05 – 13.55

NETWORKING LUNCH

Downstream Processing

13.55 – 14.30
Simulation Tools in Biotechnology

  • Implementation of modelling and simulation tools in biotechnology
  • What can biotechnology learn from the automotive industry?
  • First steps towards an “Insilico Process Development”
  • Examples of the biotech industry (e.g. Chromatography Modelling)

Dr. Martin Poggel, Head of Downstream Technologies & Analytics, Bayer

Upstream Processing

13.55 – 14.30

Challenges during the Development of a High Cell Density (HCD) Continuous Upstream Process and Evaluation of an Ambr15 Perfusion-Mimic model

An Integrated Continuous Bioprocess (ICB) is aimed to have a higher productivity, smaller footprint, fully disposable and higher cost efficiency process. Ambr15 was explored and evaluated as a screening tool for the perfusion process. The developed Ambr15 Perfusion-Mimic model was able to predict the steady state bioreactor cell density and productivity, and shows its value in perfusion process development.

During the development of a HCD continuous upstream process, the following challenges are encountered:

  • Impact of the quality and quantity of cryopreserved cells
  • Development of media able to support high cell density cultures
  • Availability of rapid analytical tools which are capable to measure CQAs at small harvest quantities
  • Micro control of a continuous cell culture process
  • Minor equipment failure leads to serious impact on performance
  • Challenges and importance of PAT during small scale runs

Steve Husson, Process Engineer, Sanofi

14.35 – 15.10

Process development approaches to continuous capture and connected downstream

  • Retrofitting a discrete fed-batch process into a continuous capture / connected downstream process
  • Strategies and challenges in process characterization
  • Case study

Mathias Goebel, Senior Scientist, Novartis

14.35 – 15.10
Implementation of HTST Media Treatment for Legacy Commercial Cell Culture Processes

  • The implementation strategy for HTST treatment of media and feeds for commercial cell culture processes is described in detail
  • A risk-based approach was developed to determine the study design and identify appropriate mitigations prior to full-scale implementation
  • A bridging study was conducted for a laboratory-scale HTST unit to establish a scale-down model to support future screening studies
  • Operational challenges were encountered on the large-scale HTST unit which had an impact on process performance. Results of the investigation and associated corrective actions are described

15.15 – 15.50

Impurity Control Strategies and Challenges in Impurity Reduction Studies

  • Different impurity control strategies
  • Pro’s and con’s for different strategies
  • Case study: Antifoam reduction study
  • Technical and analytical challenges met in reduction study

Markus Eser, Lab Head Downstream Development, Bayer AG

15.15 – 15.50

Success stories and learnings building a strong upstream manufacturing platform

  • How to cope with growing variability in molecule formats
  • Transferring knowledge from research to development to production
  • Fast to clinic
  • Seamless transition to GMP and commercial
  • Beyond fed-batch

Raphael Voges, Associate director early stage USP development, Boehringer Ingelheim

15.50 – 16.40

COFFEE BREAK & MEETINGS

16.40 – 18.10

One to One Meetings

  • 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
  • Microbial Process Development and Production
  • Lean/Transformational Change – Operational Excellence
  • Continuous Improvement / Manufacturing Processing
  • Process Engineering
  • PAT & MES, Automation and Process Control Excellence
  • QbD
  • Quality Assurance & Quality Systems
  • Regulation – Rapid Release Testing
  • Finance / Inward & Foreign Investment
  • cGMP – Contract, External Manufacturing Services
  • Biogenerics/Biobetters
  • Personalised Medicines
  • Cell & Gene Therapy
  • Fill and finish
  • Cold chain

16.40 – 17.10

A New Generation of Agarose Beads

  • Next generation resin for downstream processing
  • Advanced resin technology for continuous and batch manufacturing
  • Increased process productivity & economy
  • Ultra-high capacities on Protein A resin above 80 g/l

17.10 – 17.40

Scalable Single-Use Platform for Intensified Downstream Processing

  • Upstream Process Intensification places additional demands on Downstream Processing
  • Cost-effective solutions for high cell density clarification
  • Single-use, scalable Membrane Adsorbers can be easily adapted into connected/continuous DSP
  • Extended-use Virus filters challenge traditional approach
  • Scalable Single Use & single-pass TFF options will be discussed

17.40 – 18.10

Using Alluvial Filtration as an Effective and Economical Solution for Midstream Clarification

  • Alluvial filtration compare to other technologies
  • Economic approach for Midstream 7 Clarification
  • Robust technology – easy scalable

18.15 – 18.45

Factory of the Future 2 – The future of pharmaceutical production using the example of the GSK Marburg Site transformation

  • Trends in the pharmaceutical market. What challenges do (bio-) pharmaceutical producers in Germany have to face?
  • The Marburg Transformation – “Turning old into new”
  • Development of a vaccines manufacturing platform – Was all this planned?
  • Criteria for long-term competitiveness

Dr. Jan Weber, Head of Manufacturing Strategy & Production Systems, GSK

18.45

CHAIRPERSON’S CLOSING REMARKS AND END OF DAY ONE

18.55

NETWORKING DRINKS RECEPTION

DAY TWO

08.30 – 08.35

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

Felix Oehme, VP, Head of Biological Development, Bayer

08.35 – 09.10

Factory of the Future 3 – Plant Design Philosophy and Technology Transfer Strategy for a Large Scale Commercial Monoclonal Antibody Process

  • Design Basis for a new facility to manufacture a large volume commercial Mab
  • Utilizing Data Management and Digital tools as part of facility design concept
  • Outlining a complex node to node technology transfer
  • Validation strategy to meet an aggressive timeline

Harish Santhanam, Sr. Principal Scientist- Biologics Manufacturing and Digitization/Data Management, MSD Ireland

09.10 – 09.45
Novel and Innovative Characterization Methodology to Optimize Scale Up Strategies for Bioreactors

  • Mapping “zoning effects” in E.Coli fermenters.
  • Optimization of a CHO USP
  • Scale down and scale up strategies in combination with CFD studies.
  • Prediction of kLa – values with the help of “Big Data”

Florian Krainer, Cooperation Supervisor,Institute of Molecular Biotechnology, TU Graz

09.10 – 09.45
Bioprocessing in the digital age – paving the path towards industry 4.0 through smart digital technologies for biopharma

  • Challenges in digitalization and big data analytics in biopharma
  • Enabling role of domain knowledge versus standard statistics
  • Potential for value creation based on advanced modelling technologies as well as their integration with sensors and robotic platforms
  • Industrial use cases for the successful implementation of smart digital technologies for biopharma

Michael Sokolov, Postdoctoral Fellow and Lecturer, ETH Zurich

Downstream Processing

09.50 – 10.25
Designing “Quality by Design”

  • QbD represents a heavy workload, takes time and costs a lot. However, benefits largely outweigh the costs
  • QbD is not a goal in itself, it is only a methodology that support a reliable process development, leading to process robustness, understanding and increase safety for patients
  • The presentation will illustrate a coupole of case studies that « demistify QbD » and highlight advantages of designing QbD as an integral part of process initial development and lifecycle management

Alain Bernard, Head of Global Biotech Process Development, R-Pharma

Upstream Processing

09.50 – 10.25

Using SPOT™ and SLIM™ technologies and upstream process modulation to reduce cost of goods of manufacturing

  • Increase specific productivity using SPOT™
  • Increase specific productivity and biosimilar product quality using upstream process modulation
  • educe process hardware limitations using SLIM™ technology
  • Reducing cost of goods of manufacturing

Louis Boon, CSO, Bioceros

10.25 – 10.45

COFFEE BREAK & MEETINGS

10.45 – 12.15

One to One Meetings

  • 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
  • Microbial Process Development and Production
  • Lean/Transformational Change – Operational Excellence
  • Continuous Improvement / Manufacturing Processing
  • Process Engineering
  • PAT & MES, Automation and Process Control Excellence
  • QbD
  • Quality Assurance & Quality Systems
  • Regulation – Rapid Release Testing
  • Finance / Inward & Foreign Investment
  • cGMP – Contract, External Manufacturing Services
  • Biogenerics/Biobetters
  • Personalised Medicines
  • Cell & Gene Therapy
  • Fill and finish
  • Cold chain

10.45 – 11.15
End-to-End Processing of Biopharmaceuticals – Options for scale-up and/or scale-out strategies

  • End-to-end processing may embrace batch, continuous or hybrid technologies
  • Single-use technologies enable proven scale-up and then scale-out
  • Significant productivity improvements may be achieved through effective process design
  • Using a toolbox approach to develop and scale-up a process enables productivity improvements across a broad range of advanced biologics modalities

11.15 – 11.45

Chromassette®: A Stackable Chromatography Cassette Enabling Next-Generation Bioprocessing

  • A stackable, single-use and pre-packed chromatography cassette with a supported bed (Chromassette®) is a novel product concept in DSP, addressing the current key challenges in manufacturing.
  • Chromassette combines the separation capabilities of chromatography resins with the convenience of a pre-packed, modular cassette as shown in a range of application examples.

11.45 – 12.15
A new generation of Enterprise Systems

  • Paperless validation
  • Fully Automated
  • Validation to decommissioning
  • Validation through frameworks
  • Risk assessments

12.15 – 13.05

NETWORKING LUNCH

Downstream Processing

Upstream Processing

13.05 – 13.40
Next generation downstream process – manufacturing of biologics in a continuous way

  • Fully connected continuous downstream process for monoclonal antibodies
  • Integrated advanced analytical tools for real time monitoring
  • Complete single use setup and increased flexibility
  • Reduced costs and environmental impacts
  • High productivity

Gorazd Hribar, Project manager nextBioPharmDSP, Principal Scientist, Novartis

13.05 – 13.40
Monitoring the scale-up of a biopharmaceutical cell culture process using Raman spectroscopy at 2000 L scale in a GMP environment

  • Raman spectroscopy
  • Biopharmaceutical
  • Fed-batch
  • GMP
  • Chemometric model development

Tim Overkleeft, Specialist New Technologies, Janssen Biologics

13.45 – 14.20

Parallelized DSP steps with a single-skid at pilotscale: manufacturing strategies, buffer platforms and equipment integration

  • We performed advanced trials of a pilot-scale equipment allowing several DSP steps to be performed at the same time
  • The strategy employed was: multi-column capture step, followed by an automated viral inactivation step, followed by a depth filtration step paired with an ion exchange chromatography step
  • We also tested several features of the equipment to apply different buffer platform strategies: 1X buffers, in-line dilution and an advanced inline buffer conditioning

Nicolas-Julian Hilbold, DSP Innovation Scientist, Merck

13.45 – 14.20

Presentation title: Bio-Process Fermentation optimization: the CPV added value

  • Continued process verification basis
  • Data driven decision-making
  • Incoming materials monitoring in upstream areas of bioprocess
  • Example of process optimization starting by routine trending activities and cross-functional team work

Francesco Carpitella, MSAT Mfg. Support Manager Primary Ops & Stefano Calo, MSAT Product Steward, GSK

14.25 – 14.55

One to One Meetings

  • 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
  • Microbial Process Development and Production
  • Lean/Transformational Change – Operational Excellence
  • Continuous Improvement / Manufacturing Processing
  • Process Engineering
  • PAT & MES, Automation and Process Control Excellence
  • QbD
  • Quality Assurance & Quality Systems
  • Regulation – Rapid Release Testing
  • Finance / Inward & Foreign Investment
  • cGMP – Contract, External Manufacturing Services
  • Biogenerics/Biobetters
  • Personalised Medicines
  • Cell & Gene Therapy
  • Fill and finish
  • Cold chain

14.25 – 14.55
Digitising the entire Validation Life Cycle: a productivity leap

  • Traditional paper/hybrid manual validation processes are not efficient, not cost effective, not scalable and with high risks
  • Digital and paperless has become a strategic focus, driven by data integrity concerns and compliance risks
  • > 60% of global Pharma/ Biotech companies are actively looking to digitize the entire Validation Lifecyle
  • Learn first-hand experienced how a leading global Biotech considered, evaluated, implemented and scaled its eVal solution across its entire organisation
  • With detailed results, ROI and considerable cost & productivity savings

15.00 – 15.15

COFFEE BREAK

15.15 – 15.50

Factory of the Future 4 – Technical trends and concepts in modern bioprocessing facilities

  • Hybrid solutions
  • Digital strategies and automation
  • Process intensification
  • Buffer handling

Stefan Schmidt, Head of Operations/COO, BioAtrium AG, a Lonza and Sanofi Joint Venture

15.50

CHAIRPERSON’S CLOSING REMARKS

15.55

CLOSE

Please note: Agenda and speakers are subject to change.