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Informa
08:15 - 09:00 45 mins
Registration and Morning Coffee
09:00 - 09:10 10 mins
Cell Culture and Upstream Process Development
Chairperson's Opening Remarks
09:00 - 09:10 10 mins
Downstream Processing
Chairperson's Opening Remarks
09:00 - 09:10 10 mins
Raw Materials
Chairperson's Opening Remarks
09:10 - 09:50 40 mins
Cell Culture and Upstream Process Development
Scale Down Models for the Perfusion Process
  • Steffen Kreye - Scientist, Glycotope, Germany
more
  • Case study
  • New technology considerations for perfusion
  • What are the challenges for the scale down model in the perfusion process?
  • Screening for performance at scale down models
09:10 - 09:50 40 mins
Downstream Processing
Characterisation and Validation of Downstream Processes Using High Throughput Process Development Approaches
09:10 - 09:50 40 mins
Raw Materials
How to Establish a Control Strategy for a Raw Material for Early Phases/Clinical Trials
  • Jeanet S.K. Kring - Senior Development Scientist, CMC API GMP Material Responsible, Novo Nordisk A/S, Denmark
more
09:50 - 10:30 40 mins
Cell Culture and Upstream Process Development
Developing a Continuous Upstream Process for Lentiviral Vector Production
  • Lesley Chan - Scientist II, Vector Process Development & Manufacturing, bluebird bio, USA
more
  • Challenges of lentiviral vector production in a continuous setting
  • Identifying an appropriate medium for perfusion
  • Identifying an appropriate technology for perfusion
09:50 - 10:30 40 mins
Downstream Processing
Robot-Assisted High Throughput Development for Downstream Process
  • Albane Ferraris - Downstream Processing Technology Innovation Scientist - Biopharma Technology and Innovation, Merck Serono
more

Novel biological entities create new challenges. In response, purification processes need to be designed, tuned and evaluated faster and more efficiently to reach quality targets. Robotic systems help to step up our screening capabilities in term of number of experiences. Here will be presented the concepts and practical exploitation of a robotic system for early downstream process development. Said platform reproduces at laboratory scale a cascade of polishing steps. In one week, our screening strategies lead to seventy-seven cross combinations.

09:50 - 10:30 40 mins
Raw Materials
Linking Critical Material Attributes with Critical Product Attributes
  • Mark Plavsic - Chief Technology Officer, Lysogene, USA
more
10:30 - 11:00 30 mins
Cell Culture and Upstream Process Development
High Throughput Cell Line and Scale-down Upstream Process Screening
  • Christoph Freiberg, Ph.D. - Senior Scientific Consultant, Biologics, Genedata
more

We present use cases demonstrating the automation of the development and assessment of mammalian cell lines and related upstream processes in high throughput, including seeding, selection, passaging, cryo-conservation, as well as batch and fed-batch processing and data analysis. We show how the full history of all clones can be tracked - from initial transfection all the way to their evaluation in bioreactor runs - and how this information can be combined with product quality and analytics data. These automation approaches include the integration with instruments, such as pipetting robots, colony pickers, bioreactors and bioanalyzers and deal with cell line and process development for both antibodies (IgGs, novel formats) as well as therapeutic proteins (e.g., fusion proteins).

10:30 - 11:00 30 mins
Downstream Processing
Spotlight Technical Presentation - Sponsored by Bio-Rad
10:30 - 11:00 30 mins
Raw Materials
Supplier Perspective: Raw Materials Quality Control Strategies
11:00 - 11:30 30 mins
Morning Coffee and Networking
11:30 - 12:10 40 mins
Cell Culture and Upstream Process Development
Intensification of a Multi-Product Perfusion Platform – Managing Growth Characteristics at High Cell Density for Maximised Volumetric Productivity
  • Shawn Barrett - Associate Scientific Director, Continuous Manufacturing Skill Center, BioPharmaceutics Development, Sanofi Genzyme, USA
more

Integrated Continuous Biomanufacturing (ICB) provides many important strategic advantages for therapeutic protein production through process intensification, simplification and integration. Dramatic reductions in cost of goods manufactured can be achieved by pushing perfusion culture towards high productivity at moderate perfusion rate and integrating with multi-column capture. We have demonstrated that an in-house chemically defined medium designed for high volumetric productivity (VPR) can support clones producing different monoclonal antibodies in perfusion bioreactors at cell densities >100 million viable cells/mL and VPR from 4 to  6 g/L/day. However, for other cell lines tested productivity could not be consistently sustained due to declining growth rate at high cell density. It was demonstrated that increased bleed rates could extend the culture duration for these clones but only with substantially lower cell density and productivity, and reverting to a less productive perfusion medium improved culture longevity to a certain degree.  It was shown that continuous addition of a concentrated supplement to this medium could improve productivity to levels comparable to the high-VPR medium, but this appeared to be less effective for clones with lower specific productivity.  Some clones producing the same biologic were observed to exhibit either sustained or declining growth rate at high cell density, indicating clonal variability should be considered as another factor that can affect this growth phenotype.  Potential strategies to mitigate declining growth rate in high cell density perfusion culture will be discussed and additional case studies on the application of intensified perfusion will be examined.

11:30 - 12:10 40 mins
Downstream Processing
Integrating Automation, Robotics, Modelling and High Throughput Process Development to Streamline DSP Process Characterisation and Validation
  • Marcel Ottens - Assistant Professor, TU Delft
more
11:30 - 12:10 40 mins
Raw Materials
Further Characterisation of Animal Sera
  • Brian Lewis - President, BL Consulting, Representing ISIA, The Netherlands
more

The International Serum Industry Association (ISIA) is continuing its efforts to provide better information and tools to aid is risk management for animal derived products in use in vaccine and biotherapeutic manufacturing. The ongoing programs in Traceability, geographic origin, animal age determination and gamma irradiation will be reviewed.

12:10 - 12:50 40 mins
Cell Culture and Upstream Process Development
Next Generation Upstream Manufacturing and Novel Bioprocesses
  • Harald Bradl - Director Cell Culture Development, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
more
  • Novel and state of the art host cell line BI-Hex CHO K1
  • Usage of predictive tools and high-throughput for process development to save time and resources
  • Scale up strategy supported by CFD data to optimize the process transfer to commercial facilities
  • Start-up of a new facility in China based on single use equipment
12:10 - 12:50 40 mins
Downstream Processing
Microfluidics as a Tool in DSP for Biopharmaceutical Proteins
  • Michel Eppink - Director Downstream Processing, Synthon Biopharmaceuticals BV, The Netherlands
more

Production and development of biopharmaceutical proteins (e.g. monoclonal antibodies) is mainly performed in Chinese Hamster Ovary (CHO) cells. The process development of these biotherapeutic proteins includes Upstream and Downstream process development. During the Downstream Processing the protein of interest is purified according a chain of purification steps. Especially the chromatographic steps need quite some development time. To improve the speed of development, high-throughput screening technologies should be implemented.

In this presentation a high-throughput microfluidics method will be explained which can rapidly screen washing and elution conditions of a specific chromatographic purification step. An imaging surface plasmon resonance (iSPR) platform is used in real-time and label-free.

12:10 - 12:50 40 mins
Raw Materials
Feedback on the BPOG Raw Material Variability Workstream
  • Basak Clements - Senior Scientist, Amgen, USA
more
12:50 - 13:20 30 mins
Cell Culture and Upstream Process Development
Spotlight presentation
12:50 - 13:05 15 mins
Downstream Processing
Spotlight Presentation: A Representative from Parker
12:50 - 13:20 30 mins
Raw Materials
Spotlight presentation
13:05 - 13:20 15 mins
Downstream Processing
Spotlight Presentation: A Representative from Spectrum Labs
13:20 - 14:30 70 mins
Lunch and Networking
14:30 - 15:10 40 mins
Cell Culture and Upstream Process Development
Moving into Late Stage Development: Scaling-Up and -Down of a Platform Upstream Process
  • Lodewijk De Jonge - Scientist USP, The Janssen Pharmaceutical Companies of Johnson & Johnson, The Netherlands
more

The platform Upstream Process (USP) for production of Adenovirus-based vaccines at Janssen Vaccines is a perfusion-based PER.C6®-based cell culture process. This process has been successfully used at pilot scale for production of early clinical material for our different vaccine development programs. As some of these projects are now moving into late stage development, the USP platform process has been scaled-up to obtain a process that generates the desired product quality at a commercial volume and acceptable costs of goods. In parallel the process needs to be scaled-down to support process characterization activities that require large numbers of experiments to build process understanding and study the relations between the manufacturing process and product quality. This presentation will highlight our approach towards scaling-up and scaling-down our platform USP process and discuss some of the challenges specific to our high-cell density perfusion process.

14:30 - 15:50 80 mins
Downstream Processing
Panel Discussion: Automation, Scale Down Models and Predictive Modelling – How to Effectively Mimic Large Scale Downstream Production?
more
  • How to model processes?
  • Statistical strategy to qualify small scale studies: What are the minimum number of studies required at large scale to be performed?
  • How effectively do automation, scale down model and predictive modelling mimic large scale downstream production?
  • Adapting robotics for screening strategies for novel biologic formats
14:30 - 15:50 80 mins
Raw Materials
Panel Discussion: Raw Material Variability Control Strategies and Supply Chain Management
more

Feedback from Industry:

  • Industry strategies for monitoring and controlling raw material variability
  • Impact on productivity and product quality due to difference in critical raw materials
  • What extra process and purification steps are added to ensure raw material quality?
  • Impact of switching suppliers on critical raw material variability
  • Development towards an adaptive control strategy for raw material variability
  • Industry strategies for particle control and managing sub-visible particles

Feedback from Raw Material Suppliers:

  • How are suppliers improving raw material variability/quality and monitoring contamination?
  • Elemental impurity analysis and risk management for trace elements
  • Particle and raw material control strategies
  • Ensuring high quality supply of raw materials for GMP manufacturing
  • Raw material qualification
  • Raw material suppliers – quality of supply: Studies required, how to deal with it
15:10 - 15:50 40 mins
Cell Culture and Upstream Process Development
Extended Discussion Panel: Opportunities and Limitations with Perfusion vs. Fed Batch
more
  • Benefits and limitations of perfusion and fed batch
  • Continuous or semi continuous – how to make the call
  • Feedback on using mixed approached, where both methods are combines
  • How can DSP learn from USP?
  • Technologies
  • How to use perfusion with minimum optimization but achieve success
  • Future outlook
15:50 - 16:20 30 mins
Afternoon Coffee Break
16:20 - 16:25 5 mins
End of Conference Day One
08:15 - 09:00

Registration and Morning Coffee

Showing of Streams
11:00 - 11:30

Morning Coffee and Networking

Showing of Streams
13:20 - 14:30

Lunch and Networking

Showing of Streams
15:50 - 16:20

Afternoon Coffee Break

16:20 - 16:25
End of Conference Day One

End of Conference Day One