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Oct 10
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08:50 - 09:00 10 mins
Chairperson's Opening Remarks
  • Patrick Sheehy - Scientific Director, Janssen
09:00 - 09:30 30 mins
Bispecific antibodies – key process and analytical challenges
  • Patrick Sheehy - Scientific Director, Janssen
09:30 - 10:00 30 mins
How innovation of drugs shapes modern bioanalysis and potency assessment – The rise of ATMPs and the challenge of appropriate assays
  • Melody Sauerborn - Trainer and Independent Consultant, Scientia Potentia Consultancy

Innovation is a pivotal process in drug development to address unmet medical needs. Advanced therapy medicinal products (ATMPs) are amongst these innovations and the number of ATMPs entering clinical stages has been substantially increasing over the last few years. Bioanalysis and potency assessment has proven to be a challenge, as the mode of action for cellular therapeutics is often not fully characterized. Currently most companies apply a multi-assay approach, often consisting of cellular surface analysis, cytokine release and one form of functional cell-based assay. The challenge arises when these assays need to be validated. While walking you through some case studies, we will address these assay and regulatory challenges and how they can be handled.

10:00 - 10:30 30 mins
Accelerating the timeline to GMP through high-throughput bio-analytical tools
  • Bernardo Estupiñán-Gaisbauer - Vice President Business Development, KBI Biopharma, Inc.

  • Accelerated FIH Development requires knowledge of mAbs, bispecifics, fc-fusion proteins, recombinant enzymes, and other glycoproteins, and a good understanding of the analytical tools to drive development from cell line development through manufacturing is critical.
  • KBI will be providing a roadmap to accelerated FIH Development and also an overview of KBI’s vast capabilities to support development and manufacturing of biomolecules.
10:30 - 11:10 40 mins
Morning Coffee
11:10 - 11:40 30 mins
Analytical assay development for CAR T cell characterization
  • Eric Alonzo - Scientist, Cellular Analytics, Bluebird Bio
11:40 - 12:10 30 mins
Immunogenicity - and what about the targets?
  • Clara Albani - Scientist, Covagen

A short introduction about T-cell independent ADA response and multimeric targets (TNFα and IL-17) followed by a case study based on COVA322, a dual TNFα and IL-17A inhibitor that went into a FIH SAD Psoriasis Study stopped due to the observed safety profile

12:10 - 12:40 30 mins
A Smart Microfluidic Technology for Early Discovery and Analytics
  • Anubhav Tripathi, Ph.D., - Professor, Bioengineering and Medical Science, Brown University, USA

Protein purity analysis by microfluidic separation offers distinct advantages over traditional capillary electrophoresis in sample consumption, ease of use, and speed of analysis. Using a smart microfluidic platform for high throughput quantitation and quality screening of proteins. The method utilizes a microchip which utilizes real-time electro-hydrodynamic optimization to eliminate variability in reported results, i.e. run-to-run and day-to-day variability, which may be caused by micro-scale fluctuations in the physical properties of chips, reagents, or instrument components.

12:40 - 13:30 50 mins
13:30 - 14:00 30 mins
Poster Tour
14:00 - 14:30 30 mins
The analytical toolbox for viral vector characterisation: progress and challenges
  • Dr. Clare Trippett - Technology and Innovation Officer at the Centre for Process Innovation, Centre for Process Innovation

The field of gene therapy through the use of viral vectors has advanced rapidly in recent years with an increasing number of clinical programs moving towards market approval. As advances are made in this area there is the need for an analytical toolbox to enable rigorous characterisation of viral vectors to demonstrate purity, potency, stability and safety. In addition, the analytics to support process development for manufacture of viral vectors must be in place to ensure clinical demands can be met for different products and higher vector quantities per product.

Current analytical methods for viral vector characterisation will be discussed as well as some of the challenges faced in process development and characterisation of the expanding potential commercial product pipeline.

14:30 - 15:00 30 mins
Anisotropy Resolved Multi-dimensional Emission Spectroscopy (ARMES) for the analysis of proteins in solution: a new analytical paradigm
  • Alan Ryder - Principal Investigator - Nanoscale Biophotonics, NUI Galway

The use of intrinsic fluorescence spectroscopy for the analysis of protein structure, stability, and aggregation has significant benefits in terms of sensitivity and minimal unwanted perturbation.  However, most fluorescence-based assays use either single point measurements or two-dimensional spectra both of which have poor information content.  The situation is further complicated by the presence of multiple-fluorophores in most therapeutic proteins (e.g. IgG > 100 fluorophores…) which makes spectral interpretation difficult because of extensive spectral overlap.  To facilitate detailed structural analysis of multi-fluorophore proteins, Anisotropy Resolved Multi-Dimensional Emission Spectroscopy (ARMES) can be used to extract more information from a single fast measurement.  ARMES is a 4D measurement (λex×λem×If×r) in which the anisotropy (r) measurement can provide information about both structural and physicochemical changes and aggregation of proteins.  This novel method also involves the use and development of multivariate analysis tools to extract the most useful information from the 4D measurements which can be implemented using standard benchtop spectrometers.  Here we present some of the latest ARMES developments for the characterisation of proteins with case studies involving Insulin, IgG, and albumin type proteins.

15:00 - 15:30 30 mins
Measuring Protein Assembly at High Concentration
  • Dr. Jennifer McManus - Head of Department of Chemistry, Maynooth University

The self-assembly and aggregation of proteins can lead to the formation of protein assemblies with sizes ranging from nanometres to micrometres. For several biologic formulations, protein concentrations in excess of 150mg/ml are required. Analysis of size heterogeneity at high protein concentrations presents an analytical challenge. I will discuss methods we use for aggregation analysis at protein concentrations up to 200mg/ml.

15:30 - 16:00 30 mins
Afternoon Coffee
16:00 - 16:30 30 mins
Biophysical characterization of HexaBody®-based IgG antibodies: The impact of formulation
  • Muriel van Kampen - Senior Scientist, Genmab, Netherlands

The HexaBody® format is a novel platform for the potentiation of therapeutic antibodies by enhancement of antigen-dependent hexamer formation at the cell surface, which may drive subsequent target receptor activation or complement activation. The biophysical characteristics and stability of HexaBody-based model compounds in different formulations will be discussed, probed by a variety of analytical techniques.

16:30 - 17:00 30 mins
Computational approaches to study biopharmaceutical stability and formulation
  • Jim Warwicker - Reader, Manchester University

As software tools become available for aiding in the design and formulation of biopharmaceuticals, it is necessary to evaluate their usefulness. Such an effort requires collaboration between groups, exchange of data, and ultimately the establishment of benchmark datasets. This presentation will discuss the available predictive tools, their molecular bases, and the scope for providing benchmark evaluations to the wider community of researchers.

17:00 - 17:30 30 mins
Using Chemical Denaturants to Determine the Aggregation Propensity of Monoclonal Antibodies
  • Robin Curtis - Senior Lecturer, University of Manchester, UK

A key obstacle to predicting aggregation is difficulties in isolating the partially folded states believed to be key intermediates in the aggregation pathways. One approach not yet fully explored is to study the self association behaviour of partially or unfolded states under chemically denaturing conditions when they occur at much larger populations. Typically, these measurements are carried out using static or dynamic light scattering in terms of an osmotic second virial coefficient or a diffusion interaction parameter kD. Here we show how to account for the high concentration of denaturants in the data analysis, which if unaccounted for, could lead to data mis-interpretation. We then correlate light scattering measurements of five monoclonal antibodies at high denaturant concentration with their shelf stability. The results indicate there is a window of denaturant concentration over which the self association behaviour provides an indicator for the aggregation propensity upon storage.

17:30 - 17:35 5 mins
End of Day Three