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08:00 - 08:55 55 mins
BioAnalytical
Registration and Morning Coffee
08:55 - 09:05 10 mins
BioAnalytical
Chairperson's Opening Remarks
  • Tudor Arvinte - Chairman, CEO, Therapoemic Inc., University of Geneva, Switzerland
more
09:05 - 09:25 20 mins
BioAnalytical
Case Study: Successful Analytical Development of a Novel Therapeutic
  • Declan Lowney - Manager, Late Development Portfolio and Stability Sciences, Analytical Development, Janssen, Ireland
more
09:25 - 09:45 20 mins
BioAnalytical
Phosphorylation of glycine-serine linker in a novel IgG-based fusion protein format
  • Hans-Rainer Voelger - Pharma Research and Early Development, Roche Diagnostics GmbH, Germany
more
  • Impact of domain linkers on fusion protein heterogenity profile
  • Detection and characterization of linker peptide modifications by mass spectrometry
  • Comparing in-silico prediction of phosphorylation and experimental observations
09:45 - 10:05 20 mins
BioAnalytical
Using Predictive Tools to Determine Developability – What Drives Stability, Aggregation and PK?
  • Tudor Arvinte - Chairman, CEO, Therapoemic Inc., University of Geneva, Switzerland
more
  • What predictive tools can be used to determine developability of these novel therapeutics?
  • What drives the PK and stability with regards to structural characterisation?
  • Studies looking at why something has more aggregation or more PK – and why?
10:05 - 10:25 20 mins
BioAnalytical
Discussion panel - Analytical strategies for novel antibodies, proteins and biomolecules
  • Declan Lowney - Manager, Late Development Portfolio and Stability Sciences, Analytical Development, Janssen, Ireland
  • Hans-Rainer Voelger - Pharma Research and Early Development, Roche Diagnostics GmbH, Germany
  • Tudor Arvinte - Chairman, CEO, Therapoemic Inc., University of Geneva, Switzerland
  • Syd Johnson - Vice President, Antibody Engineering, MacroGenics Inc., USA
  • Oscar Salas - Solano - Senior Director Analytical Sciences, Seattle Genetics, USA
more
  • Nucleotides
  • ADC’s/Bispecifics
  • Fc fusion protiens
  • Gene therapies
  • Specific functional modifications
  • Analytical strategies
  • How do you formulate these?
  • Risk assessments
  • Molecule design
  • How will they behave in the clinic?

 

 

 

10:25 - 10:45 20 mins
BioAnalytical
A New Mass Spectrometry Paradigm: Partnering with BioProcess Development to Enhance Product Quality
  • Lisa Marzilli - Associate Research Fellow, Pfizer, USA
more

Heightened characterization of protein biotherapeutics typically involves various ultrahigh resolution LC/MS methods to confirm the expected primary structure and posttranslational modifications. However, application of these MS-based methods during clone selection and cell culture process development has yielded vital product quality information at the molecular level that helped steer process development, enabling the selection of more robust cell lines and increased process understanding and consistency. In this presentation, we will share several experiences and lessons we have learned in the application of ultrahigh-resolution MS-based methods for bioprocess development.

10:45 - 11:15 30 mins
BioAnalytical
Morning Coffee and Networking
11:13 - 11:15 2 mins
Stability Testing and Analytical Method, Development, Validation and Transfer for Biologics
Chairperson's Opening Remarks
  • Declan Lowney - Manager, Late Development Portfolio and Stability Sciences, Analytical Development, Janssen, Ireland
more
11:13 - 11:15 2 mins
Protein Characterisation, Post Translational Modifications and Formulation
Chairperson's Opening Remarks
  • Dan Kristensen - Principal Scientist, Symphogen A/S, Denmark
more
11:15 - 11:50 35 mins
Protein Characterisation, Post Translational Modifications and Formulation
Evaluating CQA’s: Case Study
  • Bodo Brocks - Director Analytics, Protein Science & CMC, Morphosys, Germany
more
  • Case study
  • How are they best evaluated?
  • Monitoring for immunogenicity outcomes etc.
  • Monitoring strategies
11:15 - 11:50 35 mins
Stability Testing and Analytical Method, Development, Validation and Transfer for Biologics
A presentation from Merck Serono
  • Eugenio Galano - Associate Researcher, Merck Serono, Italy
more
11:50 - 12:25 35 mins
Protein Characterisation, Post Translational Modifications and Formulation
Structure/Function Assessment of Sulfated N-Linked Glycans from Non-mAb Protein Therapeutics
  • Sherry Castle - Rapid Response Team, Analytical Development, Process Development and Technical Operations, Shire, USA
more

Therapeutic glycoproteins containing sulfated N-linked glycans are uncommon. Here we present structural characterization of sulfated glycans observed on a non-mAb protein. Functional characterization based on both in-vitro and in-vivo studies is discussed.


11:50 - 12:25 35 mins
Stability Testing and Analytical Method, Development, Validation and Transfer for Biologics
Teleconference: Ensuring Biosimilar Clinical Success Through Novel Biomarkers
  • Uwe Gudat - Head of Safety, Biosimilars, Merck Biosimilars, Switzerland
more
12:25 - 12:55 30 mins
Protein Characterisation, Post Translational Modifications and Formulation
Getting MS data from your charge-based separation results: iCIEF charge profiling and fraction collection for protein characterization
  • Aurélien Baudot - Area Manager BeLux, Isogen Life Science B.V, The Netherlands
more

Imaged capillary isoelectric focusing (iCIEF) has quickly arisen as a charge profiling technique. It is quicker and more robust than its conventional counterpart, cIEF. Nevertheless, further characterization of the isoforms on MS remained an issue. By combining precise mobilization and a novel cartridge design, the CEInfinite addresses fractionation and allows the accurate recuperation of isoforms for downstream analyses.

12:25 - 12:55 30 mins
Stability Testing and Analytical Method, Development, Validation and Transfer for Biologics
A presentation from KBI
  • Bernardo Estupiñán-Gaisbauer - Vice President, Business Development, KBI Biopharma Inc., USA
more
12:55 - 14:10 75 mins
BioAnalytical
Lunch, Networking and Posters
more

Poster 1:  FTIR spectroscopy as a multi-parameter analytical tool for stability studies and batch consistency testing of therapeutic proteins

Allison Derenne, Spin-Off Developer, Universite libre de Bruxelles 

14:10 - 14:45 35 mins
Protein Characterisation, Post Translational Modifications and Formulation
Flash Presentations: Mass Spectrometry, and other orthogonal methods for HCP Characterisation
  • Miriam Boehm - Bench Scientists, Sanofi, Germany
  • Donald Walker - Principal Research Associate, Genentech, A member of the Roche Group, USA
  • Markus Haindl - Director Development Analytics, Roche Diagnostics, Germany
more
  • When you do MS and reach the limit set by the regulators how do you deal with this?
  • Is MS the best method for characterisation?
  • What has been the impact of MS and other orthogonal methods on HCP characterisation?
  • HCP assays – biosimilar specific case study
  • Quality control aspects of HCP testing
  • Details on the sensitivity of different analytical methods


Talk 1: An Integrated LC-MS/MS Strategy for Comprehensive Detection and Quantification of Host Cell Proteins in Biopharmaceuticals

Donald Walker, Genentech-A Member of the Roche Group

Liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) has assumed an increasingly important role for characterization of host cell protein (HCP) impurities in biopharmaceuticals, with a variety of options now available to deal with the specific challenges of HCP identification and quantification.  We present an integrated LC-MS/MS strategy that is comprehensive, flexible, and robust and can easily be adapted to meet the specific sensitivity and throughput requirements needed for today’s competitive bioprocess development environment. Beginning with HCP identification, we describe a robust 1D LC –MS/MS method with the speed necessary to support process development.  Next we describe an offline 2D LC-MS/MS method that can be easily optimized to achieve higher sensitivity levels.  Following HCP identification, targeted analysis can be explored which use comprehensive ion libraries to track and quantify all HCPs through in-process purification pools.  Finally, absolute quantification is discussed using specific examples to show high sensitivity methods for tracking levels of specific HCPs using known amounts of protein or peptide standards. These methods in combination provide the necessary tools for generation of timely, reliable data, and allow development of purification processes which result in products with low and consistent levels of HCPs.


14:10 - 15:20 70 mins
Stability Testing and Analytical Method, Development, Validation and Transfer for Biologics
Dual dialogue: Forced Degradation Studies to Demonstrate Formulation Limits
  • Olivier Brass - Formulation Development Unit Head, Sanofi Pasteur, France
  • Paul Weisbach - Scientist I, Analytical Pharmaceutical Sciences, ImmunoGen Inc
more

Talk 1: Forced Degradation Studies to Demonstrate Formulation Limits

Olivier Brass, Formulation Development Unit Head, Sanofi Pasteur, France


Talk 2: Determination of the forced degradation conditions for generating antibody and ADC samples with desired degradation levels

Forced degradation is used for multiple purposes during drug development, including the evaluation of the stability indicating nature of the analytical methods. The typical stress conditions applied to protein therapeutics are exposures to low and high pH, UV and white fluorescent light, heat and oxidizing agents. To achieve the desired degradation level, the stressing conditions need to be established. The presentation will discuss the methodologies for forced degradation applied to an antibody and its conjugate (ADC).

Paul Weisbach, Scientist I, Analytical Pharmaceutical Sciences, Immunogen, USA

14:45 - 15:20 35 mins
Protein Characterisation, Post Translational Modifications and Formulation
A case study for characterization of product-related substances and impurities of a therapeutic mAb
  • Lorène Bernasconi - Analytical Development Lab Manager, Novimmune SA, Switzerland
more
15:20 - 15:50 30 mins
Stability Testing and Analytical Method, Development, Validation and Transfer for Biologics
The Design of Biopharmaceutical Stability Studies
  • Jordi Trafach - Biological Characterisation Delivery Manager, Intertek Pharmaceutical Services, UK
more
15:20 - 15:50 30 mins
Protein Characterisation, Post Translational Modifications and Formulation
High-throughput light scattering technologies for biophysical screening and characterization
  • Daniel Some - Principal Scientist, Wyatt Technology Corp, USA
more

Multi-angle and dynamic light scattering have become essential for the characterization of biotherapeutics, providing key biophysical properties and stability evaluation. This talk will focus on advanced light scattering tools for high-throughput, low-volume applications such as early stage characterization, developability assessment and formulation. A common microwell-plate format streamlines the workflow between these and other measurement technologies.

15:50 - 16:20 30 mins
BioAnalytical
Afternoon Coffee Break
16:20 - 16:55 35 mins
Protein Characterisation, Post Translational Modifications and Formulation
Teleconference: HCP Detection Case Study - presented via Teleconference
  • Valerie Quarmby - Staff Scientist and Director, BioAnalytical Sciences, Genentech, A member of the Roche Group, USA
more
16:20 - 16:55 35 mins
Stability Testing and Analytical Method, Development, Validation and Transfer for Biologics
Please move to another stream
16:55 - 17:25 30 mins
Protein Characterisation, Post Translational Modifications and Formulation
Glycans Before Lunch: Rapid N-Glycan Sample Preparation Workflows for Liquid Chromatography and Capillary Electrophoresis Platforms
  • Marco Rhotert - Technical Support Manager, Europa Prozyme, Europe Aps
more

Glycosylation is frequently a critical quality attribute of biotherapeutics, making the characterization of N-glycans an essential part of the development process. We present a rapid N-glycan sample preparation platform with a choice of labels for LC, LC-MS and CE applications. The Gly-Q CE platform enables relative N-glycan quantification for up to 96 cell culture samples within a single workday.

16:55 - 17:25 30 mins
Stability Testing and Analytical Method, Development, Validation and Transfer for Biologics
Characterization of sub-visible particles with multi-spectral imaging flow cytometry
  • Christine Probst - Application Specialist, Amnis Corporation, Part of Merck Millipore
more

Multi-spectral imaging flow cytometry (MIFC) is an established analytical method for cellular analysis, however has only recently been evaluated for characterization of sub-visible particles in therapeutic formulations1 despite numerous favorable attributes including:

• Simultaneous collection of bright-field, side-scatter, and fluorescent imagery

• Sensitive detection of particles 100 nm-100 μm

• High image quality using 20X-60X magnification objectives

• 100% sampling efficiency using hydrodynamic focusing

• Small sample volume requirement (20 μL)

• Linear concentration range up to 100 million/mL

• Wide flow cell (250 μm) minimizes clogs

Assorted case studies using MIFC for analysis of protein and vaccine formulations will be presented, with an emphasis on measurements and samples that pose challenges for current techniques. First, MIFC sensitivity was compared to dynamic imaging. While concentration measurements matched for polystyrene beads 2 µm and up, MIFC measured higher concentrations of protein aggregates, especially for particles smaller than 10 µm. Interestingly, one sample containing aggregated lysozyme including particles >25 µm were undetected by dynamic imaging but detected using MIFC by labeling particles with ProteoStat fluorescence dye.  Next, protein aggregates and silicone oil droplets were classified using MIFC by labeling samples with fluorescent dyes specific to each particle type (ProteoStat and BODIPY, respectively), demonstrating that particles can be classified independent of size. This approach also allowed measurement of protein aggregate-silicone oil complexes and protein adsorption to the surface of silicone oil droplets. Finally, MIFC was used to directly measure highly concentrated formulations. In one case, concentrated glucagon fibrils were evaluated for amyloid conformation using ThioFlavinT fluorescent dye, and size-distribution analysis revealed that large glucagon fibrils disassociate upon sample dilution. In a second case, interaction of adjuvant particles with protein was evaluated using Nile Red, which showed protein adsorbs to large adjuvant particles and causes disassociation. For the third case, concentrated virosomes were detected using MIFC using Nile Red, and swarm detection could be visualized in collected imagery, indicating samples must be diluted for accurate concentration measurements. The results demonstrate that MIFC overcomes important challenges faced by current analytical methods for analysis of therapeutic formulations, including detection of small and transparent particles, direct analysis of highly concentrated formulations, as well as fluorescence characterization of particle type, heterogeneous interactions, and chemical composition.

17:25 - 17:30 5 mins
Protein Characterisation, Post Translational Modifications and Formulation
Chairperson's Closing Remarks
  • Dan Kristensen - Principal Scientist, Symphogen A/S, Denmark
more
17:25 - 17:30 5 mins
Stability Testing and Analytical Method, Development, Validation and Transfer for Biologics
Chairperson's Closing Remarks
  • Declan Lowney - Manager, Late Development Portfolio and Stability Sciences, Analytical Development, Janssen, Ireland
more
17:40 - 18:25 45 mins
BioAnalytical
Closing Plenary Session: Rosetta Lander – Philae: A Long-Term Space Project to Land on a Comet
  • Stephan Ulamec - Philae Project Manager, German Aerospace Center, Germany
more

Philae is a comet Lander, part of the ESA Rosetta Mission to comet 67P/Churyumov-Gerasimenko.  After about ten years of development and a ten-year cruise through the solar system it successfully landed on the nucleus of the comet on November 12th, 2014.

Since the anchoring harpoons, which were expected to fix the lander to ground, did not work, Philae bounced in the low gravity environment, and only came to rest after a 2 hour’s “hop” in an unforeseen area on the comet surface.   Fortunately, the scientific instruments, including cameras, mass spectrometers, a magnetometer and a radar instrument could be operated, and fascinating, unprecedented scientific results have been obtained from the surface of an active comet.

Interplanetary space missions, including a long development phase and elaborated qualification tests do have similarities with pharmaceutical research, where time-spans between the concepts for a new drug until readiness for marketing can be similar.

Rosetta is an ESA mission with contributions from its member states and NASA. Rosetta's Philae Lander is provided by a consortium led by DLR, MPS, CNES and ASI with additional contributions from Hungary, UK, Finland, Ireland and Austria.

18:25 - 19:25 60 mins
BioAnalytical
Networking Drinks and Evening Social Event