DAY ONE

07.45 – 08.30

Registration

08.30 – 08.40

Welcome & Chairman’s Opening Remarks for Day One

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.

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.

The talk will cover how an existing commercial roller bottle process for a complex non-Mab protein can be replaced by a modern 2000L single use bioreactor process. Based on the process description the challenges and constrains for this switch in terms of productivity, product quality, manufacturing and regulatory impact (avoid clinical studies) will be explained. More details on how we increased product titer while using the existing cell line by a factor of 10 and consequently the potential to decrease plant utilisation time by a factor of 10 (significantly reducing overall production costs) will be shared. The second part of the talk will focus on bringing some initial out of specification quality attributes back within limits. In addition, we will elaborate on some severe scale up issues, mainly due to depth filtration.

The fruitful joint up- and downstream approach which could this success story make happen will be embedded throughout the talk.

09.15 – 10.00

Downstream Purification and Automation Strategies for Microbial Expressed Proteins

  • Microbial expression
  • Downstream process development
  • High Throughput Development
  • Automation and parallelization
  • Interdependencies between upstream and downstream development

10.00 – 10.50

COFFEE BREAK & MEETINGS

10.50 – 11.25

Late stage cell culture and leveraging platform knowledge

  • In phase III cell culture, scientists must consider ways to optimize cell-culture conditions while maintaining productivity, quality and consistency
  • In addition to optimization, one must consider how to maintain these attributes when scaling-up, scaling-down and in tech transfer
  • In this presentation, we will outline the hurdles scientists may face in late stage cell culture and how automation platforms can help navigate these challenges

11.25 – 12.25

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

11.25 – 11.55
The Evolution of Bioprocess Filtration Single Use Automation: From the Laboratory Bench to the Final Package

  • Why automating a single use bioprocess leads to increased process efficiency and reduces risks.
  • Overview of Parker Hannifin-the worlds leading motion and control company- and our offering in single use automation for bioprocessing applications.
  • How small-scale automation can be used to ensure scale up accuracy and filter performance at cGMP level.
  • The Parker SciLog FD- Automating bulk filtration and dispensing applications. The strategic benefits of automating this process.
  • Parker SciLog Automated NFF Systems – optimise, control and simplify NFF processes.

11.55 – 12.25
Fibro chromatography: Ultrafast purification platform addressing mAb purification bottlenecks

  • First truly Single-use Protein A capture chromatography technology
  • Case study data of Pilot scale purification
  • Process scale opportunities available in the near future explored

12.25 – 13.15

NETWORKING LUNCH

Downstream Processing

13.15 – 13.50
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)

Upstream Processing

13.15 – 13.50

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

13.55 – 14.30

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

13.55 – 14.30
Challenges and opportunities during mammalian cell culture process development through to clinical manufacture

  • Overcoming upstream hurdles during project progression
  • Case studies from development through to manufacture
  • Working to accelerated timelines
  • Collaborative approach required to ensure success

14.35 – 15.10

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

14.35 – 15.10

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

15.10 – 16.00

COFFEE BREAK & MEETINGS

16.00 – 17.30

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

16.00 – 16.30

The future of Protein A affinity chromatography

  • Process intensification by resin design
  • Very high productivity
  • Minimal buffer consumption
  • Cost effective purification
  • Salt tolerant IEX resins for high resolution applications

16.30 – 17.00

Using Alluvial Filtration as an Economical Solution for Midstream Clarification

  • Economical, Effective and robust single-use method
  • Linear scalable from development to process
  • Combined method to remove cells and HCP`s
  • Step reduction for midstream applications (Replacing centrifuge and other technologies for midstream)

17.00 – 17.30

Chromassette®: A stackable chromatography cassette enabling next-generation bioprocessing

  • Chromassette®, a novel technology platform in DSP, is a stackable, disposable and pre-packed chromatography cassette with an integrated resin bed support.
  • It combines the separation capabilities of chromatography resins with the convenience of a pre-packed, modular cassette
  • a range of application examples will be presented, including hyper-productive PrA capture, continuous chromatography and pilot-scale Chromassette stacking results.

17.35 – 18.05

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

  • The Marburg Transformation – “Turning old into new”
  • Development of a vaccines manufacturing platform – Was all this planned?
  • Criteria for long-term competitiveness

18.05

CHAIRPERSON’S CLOSING REMARKS AND END OF DAY ONE

18.15

NETWORKING DRINKS RECEPTION

DAY TWO

08.30 – 08.35

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

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

Digitalization

Upstream Processing

09.15 – 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

09.15 – 09.45
Novel and Innovative Characterization Methodology to Optimize Scale Up Strategies for Bioreactors

  • Oxygen Transfer Rate
  • Improving the Standard Measuring Method
  • Reactor Scale Up/Down
  • Optimizing Cell Culture Processes

09.50 – 10.25
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

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

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
High Productivity Harvest- Intensify and displace clarification in Fed Batch cell culture

  • How can I gain from process intensification with the least effort?
  • Should I retrofit my facility to become continuous or not?
  • Is it possible to introduce intensification changes in late clinical or post commercial phases?

11.15 – 11.45
LenS3 – A new Paradigm in MALS Technology

  • Introduction to Light Scattering
  • The flow path and optical design
  • A new Approach to Size Determination
  • Sensitivity in HPLC and UHPLC
  • Combining Tosoh’s Process Chromatography, Analysis and Detection

11.45 – 12.15
Customized, one-stop-shop solutions for biopharmaceutical development and production

  • Full-Service gene to vial solutions, addressing clinical and commercial needs
  • Best-in-class formulation development as a critical part in process development
  • Extensive track record, 40 years of experience and quality made in Germany
  • Effectively addressing development volatility and portfolio management

12.15 – 13.05

NETWORKING LUNCH

13.05 – 13.40

Biologics process intensification during development and production

  • Process intensification strategies for mAbs
  • Continuous versus semi-continuous versus fed-batch
  • Plant design
  • Adaptations of regular facilities for process intensification

Downstream Processing

Upstream Processing

13.45 – 14.20
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

13.45 – 14.20

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

14.25 – 15.00

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

14.25 – 15.00
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

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

15.50

CHAIRPERSON’S CLOSING REMARKS

15.55

CLOSE

Please note: Agenda and speakers are subject to change.