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.

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.

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

Chair: Felix Oehme, Bayer

Upstream Processing/Quality

Chair: Dr. Berthold Boedeker

10.50 – 11.25
GlyXbox: From Basic Research to Bioanalytical and Biomedical Applications

  • High performance glycoanalysis – combining expertise & pace
  • Glycomics, Glycoproteomics & Glycopeptide Mapping
  • Glycoanalysis on 3 levels: glycofingerprinting, glycoprofiling & site-specific glycoanalysis
  • Cutting edge technologies providing tailored solutions for a broad repertoire of glycosamples (e.g. biopharmaceuticals, stem cells, blood serum)

Samanta Cajic, Bioprocess Engineering, PhD Student, Max Planck Institute for Dynamics of Complex Technical Systems

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

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, MF Engineer Supervisor DSP, Sanofi Genzyme

11.30 – 12.05

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, Chief Technology Officer, VectivBio

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
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.

12.35 – 13.05
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

13.05 – 13.55

NETWORKING LUNCH

Downstream Processing

Chair: Felix Oehme, Bayer

13.55 – 14.30
Simulation Tools in Biotechnology
(Presenter: M. Poggel, Co-Author: K. Kaiser)

  • 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

Chair: Dr. Berthold Boedeker

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

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

14.35 – 15.10
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

Anagha Eswar, Scientist I, AstraZeneca

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

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

17.10 – 17.40

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)

17.40 – 18.10

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.

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

Digitalization

Chair: Felix Oehme, Bayer

Upstream Processing

Chair: Dr. Berthold Boedeker

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

Dr.-Ing. M. Nicolas Cruz-Bournazou, Process modelling expert and Research associate, ETH Zurich

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

Florian Krainer, Process Engineer and Project Development/Cooperation Supervisor, ZETA GmbH

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

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

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
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

Dr. Berthold Boedeker, Independant consultant, retired Chief Scientist, Bayer AG, Biologics Development

Downstream Processing

Chair: Felix Oehme, Bayer

Upstream Processing

Chair: Louis Boon, Bioceros

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

Mathias Goebel, Senior Scientist, Novartis

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

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

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

Nicolas-Julian Hilbold, DSP Innovation Scientist, Merck

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

Tim Overkleeft, Specialist New Technologies, Janssen Biologics

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

16.15

BioTalk is pleased to invite you to TU Berlin’s High Throughput Bioprocess Development Lab Tour.

The High Throughput Bioprocess Development Lab investigates novel methods to the design of automated
experiments implementing model-based screening, scale up/down, and operation of the robotic facilities.
Current activities focus on the development and implementation of scale-down experiments in 24 bioreactors
in parallel. Optimal Screening Design for Knock Out strain selection, and Adaptive Structure Models for
Yeast 48 parallel cultivations among others.

If you are interested to attend then please meet with Dr. Nicolas Cruz-Bournazou (Speaker) at the BioTalk registration desk at 16.30. The tour will run from 17.00 to 18.00 and will be hosted by Prof. Sebastian Hans Chair of Bioprocess Engineering TU Berlin and limited to 20 participants.

Please note: Agenda and speakers are subject to change.