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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

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
09:00 - 09:10 10 mins
Cell Line Development & Engineering
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 - USP Development Scientist, Glycotope GmbH, 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
  • A Representative - from, Roche Diagnostics
more
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
09:10 - 09:50 40 mins
Cell Line Development & Engineering
Monoclonality Assessment of Existing Production Cell Lines
  • Martin Bertschinger - Deputy Director Cell Sciences, Glenmark Pharmaceuticals SA.
more

It is a regulatory requirement (ICH Q5D) that cells used for the production of therapeutic antibodies have to be clonal, i.e. derived from a single cell progenitor. The FDA has recently provided guidance on acceptable procedures for the generation of clonal cell populations (e.g. two subsequent rounds of limiting dilution). In case cell lines were generated using a process not fully compliant with the procedures suggested by the FDA, additional data need to be generated. Glenmark has developed a method using the statistical analysis of presence and absence of specific genetic features in a population of sub-clones to assess the monoclonality status of a cell population. The method can be applied to existing cell lines with unknown monoclonality status and may allow to avoid changing the production clone or adapting the control strategy (if no secondary population can be detected).

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
09:50 - 10:30 40 mins
Cell Line Development & Engineering
Use of the Cyto-Mine for Rapid Generation of Clonal Cell Lines
  • Thomas Kelly - Scientist, Janssen R&D, Inc.
more

The Cyto-Mine is a microfluidic instrument designed for encapsulating single-cells in picodroplets and FRET-based productivity screening in a single-use cartridge. We have tested this instrument and method with mAb and non-mAb projects and found it can generate cell lines with high productivity, high viability, and a high assurance of clonality after a single round of screening, all in shorter timelines.

10:30 - 11:00 30 mins
Cell Culture and Upstream Process Development
High Throughput Cell Line and Scale-down Upstream Process Screening
  • Christoph Freiberg - Senior Scientific Consultant, 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
Monoclonal Antibody Purification: A Two-Step Approach using Nuvia™ aPrime™ Media
  • Marian Magdy - Senior Unit Head Protein Purification, Minapharm Pharmaceuticals
more

Monoclonal antibodies (mAb) increasingly form the majority share of the product pipeline of major biopharmaceutical companies. Challenges in the purification of monoclonal antibodies (mAbs) include reducing production cost, developing robust processes for both product purity and viral clearance, and integrating upstream and downstream processes.

Traditional monoclonal antibody purification platform include three chromatography steps. Protein A chromatography is first used for capture of the product followed by two chromatography steps to remove host-cell proteins, DNA, charged variants, and aggregates.

Alternatively, a well-optimized chromatography step with Nuvia™ aPrime™ media, a mixed-mode chromatography resin, can eliminate an entire step of the process, allowing the development of a two-step strategy following capture using protein A. This two-step strategy decreases production costs significantly by reducing process time, buffer consumption, media costs, while at the same time increases product yield.

10:30 - 11:00 30 mins
Raw Materials
Supplier Perspective: Raw Materials Quality Control Strategies
10:30 - 11:00 30 mins
Cell Line Development & Engineering
HT-NIC, a Novel High-Throughput Nanowell-Based Image-Verified Cloning Platform for Fast Generation of Clonal Production Cell Lines with Integrated Monoclonality Proof
  • Volker Sandig - Chief Scientific Officer, ProBioGen GmbH
more

Along with productivity, PTMs, process robustness and expression stability proven clonality is key for pharmaceutical cell line development. Automated Lab Solutions (ALS) has developed a novel technique to reliably image individual cells and automatically select and isolate resulting colonies from liquid medium based on its automated cell picking platform ALS CellCelector. The approach provides unique in-process validation of clonality and allows parallel assessment of growth and productivity for thousands of colonies. We will demonstrate its performance within cell line development workflow with single cloning round.

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.

11:30 - 12:10 40 mins
Cell Line Development & Engineering
NGS-Mediated Analysis of Cell Line Monoclonality
  • Nicolas Mermod, Ph.D. - Professor, Director, Institute of Biotechnology, University of Lausanne, Switzerland
more

Cellular whole genome analysis by NGS can be used to assess the genomic integration locus of the transgenes, as well as the propagation of single-nucleotide variants that result from genome-wide mutations. This presentation will illustrate how this can be used to assess the monoclonal origin of CHO cell populations, and how this can reliably detect even minor population contaminants in non-clonal populations.

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
12:10 - 12:30 20 mins
Cell Line Development & Engineering
Shifting The CMC Outsourcing Paradigm For Small Biotechs In The Competitive Immuno-Oncology Field By Establishing Robust Cell Line Development Capabilities
  • Alessandro Mora - Senior Scientist, Cell Line Development, CMC, Jounce Therapeutics
more

Timely generation of good quality CHO cell lines that can be seamlessly transferred to a CDMO is a key activity during IND-enabling studies for an immuno-oncology candidate. In this talk, we describe the selection process for in-licensing a CLD technology, optimization of CLD platform, and development of cell lines for model molecules. The host cell line, vector configuration, medium and utilization of a scale-down model are all factors in expediting development timelines.

12:30 - 12:50 20 mins
Cell Line Development & Engineering
Philogen’s Platform for the Development of Immunocytokines
  • Mattia Matasci - Head Cell Line Development, Philochem AG, Philogen Group
more
  • The presentation will focus on Philogen’s strategies for the development and manufacturing of antibody-cytokine fusion proteins (immunocytokines)
  • Overview of immumocytokines engineering, quality evaluation and manufacturability assessment
  • Description of Philogen’s cell line development platform
  • Examples of immunocytokines under preclinical and clinical development.
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
12:50 - 13:20 30 mins
Cell Line Development & Engineering
Dispensing a Single Cell per Well with High Viability and Image-Based Documentation
  • Jonas Schoendube - CEO, cytena GmbH
more

cytena’s single-cell printer uses an imaging system and object recognition algorithms to detect cells in a single-use dispenser cartridge. Droplets are produced similar to inkjet printing. Cells are classified in the nozzle and subsequently dispensed directly into well plates. Image sequences of the printing process enabling assurance of clonality. High viability has been observed for several cell lines (CHO: >85 %; HEK: >90 %; L292: >80 %) and furthermore customer data will be presented.

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
14:30 - 14:50 20 mins
Cell Line Development & Engineering
Cell Line Development Strategies for Bispecifics
  • Claire Harris - Scientist, MedImmune
more
14:50 - 15:10 20 mins
Cell Line Development & Engineering
Cell Line Development for Expression of Bispecific DART® and Trispecific TRIDENT™ Molecules
  • Valentina Ciccarone - Principal Scientist, Antibody Engineering, MacroGenics, Inc.
more

DART and TRIDENT molecules have been designed to achieve multiple mechanisms of action and clinical applications.  They are composed of two to four peptide chains which need to assemble correctly for functional activity. The appropriate expression of each component by the production cell line is important in achieving high expression levels and product quality in order to successfully manufacture the clinical product.  By incorporating molecule engineering strategies, optimizing vector selection, and cell line screening, we have been able to achieve correct molecule assembly, high expression levels, and biological activity of these complex, multi-chain molecules. 

15:10 - 15:50 40 mins
Cell Culture and Upstream Process Development
Extended Discussion Panel: Opportunities and Limitations with Perfusion vs. Fed Batch
  • Steffen Kreye - USP Development Scientist, Glycotope GmbH, Germany
  • Lesley Chan - Scientist II, Vector Process Development & Manufacturing, bluebird bio, USA
  • Shawn Barrett - Associate Scientific Director, Continuous Manufacturing Skill Center, BioPharmaceutics Development, Sanofi Genzyme, USA
  • Harald Bradl - Director Cell Culture Development, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
  • Lodewijk de Jonge - Scientist USP, The Janssen Pharmaceutical Companies of Johnson & Johnson, The Netherlands
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
15:10 - 15:50 40 mins
Cell Line Development & Engineering
Rapid Generation of High Titre Stable Producer Cell Lines for Lentiviral Vector Manufacture
  • Conrad Vink - Vector Development, Advanced Therapy Delivery, GSK
more

Lentiviral vectors are showing success in the clinic but large scale manufacturing remains a significant bottleneck to delivering these vectors to patients. Current manufacturing approaches are largely based on transient transfection of plasmid DNA into adherent HEK293T cells. This approach is expensive and challenging to scale beyond 10s of litres of harvested medium. This talk will present GSK’s alternative approach to lentiviral vector manufacturing based on cell line development of high titre stable suspension clones.

15:50 - 16:20 30 mins
Afternoon Coffee Break
16:20 - 16:25 5 mins
End of Conference Day One