developability screening and optimisation

The Optimisation & Developability conference at PEGS Europe looks at innovative approaches, methods and models that scientists use to develop strategies for candidate selection and optimization. Today, the field of optimization and developability takes a step toward digitalization, where scientists are starting to apply machine learning, deep learning and in silico approaches to assess developability and manufacturability.

Final Agenda


Recommended Short Course*

SC3: Mutation and Selection Strategies Beyond Affinity Optimisation - LEARN MORE

SC4: Surfactants in Biotherapeutics: Can't Live with Them, Can't Live without Them - LEARN MORE

*Separate registration required.

12:00 Conference Registration (Foyer A)

Auditorium VI

13:30 Organiser’s Welcome

Mimi Langley, MBA, Senior Conference Director, Cambridge Healthtech Institute

13:35 Chairperson’s Opening Remarks

Lars Linden, PhD, Director & Head, Protein Biochemistry, Bayer Healthcare AG

13:45 KEYNOTE PRESENTATION: Developability Assessment to Enable Candidate Selection of Therapeutic Proteins

Steffen Hartmann, PhD, Head, Characterization, Formulation and Bioinformatics, Novartis Pharma AGSteffen Hartmann, PhD, Head, Characterization, Formulation and Bioinformatics, Novartis Pharma AG






14:15 Developability of Hexabody®-Based IgG Antibodies: The Impact of Formulation on Colloidal and Conformational Stability

vanKampen_MurielMuriel van Kampen, PhD, Senior Scientist, Genmab

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.

14:45 An Integrated Approach for Optimization and Developability Assessment of Peptides Intended for Multiple-Dose Pen Devices

Evers_AndreasAndreas Evers, PhD, Senior Scientist, Synthetic Molecular Design, Integrated Drug Discovery, Sanofi

Physicochemical properties of peptides need to be compatible with the manufacturing process and formulation requirements to ensure developability toward the commercial drug product. This aspect is often disregarded and only evaluated late in discovery, imposing a high risk for delays in development, increased costs, and finally for the project in general. In the presentation, a general roadmap is proposed to optimize physicochemical properties towards developability of peptide drugs by combining experimental and in silico profiling to provide stable peptide formulations at the end of discovery.

15:15 Probing Proteins in Small Volumes

Knowles_TuomasTuomas Knowles, Professor, Department of Chemistry, University of CambridgeFluidicAnalytics

Probing protein-protein interactions in small volumes using microfluidics. Measurements that are challenging on bulk scales become more accessible on microfluidic scales. In particular, the absence of convective mixing allows PPI’s to be probed under native conditions in solution through monitoring changes in diffusivity as they interact. We show the applicability of this approach to different classes of interacting protein systems. Finally, we outline our efforts to bring this technology to market in an easy-to-use platform.

15:45 Networking Refreshment Break (Foyer D)

Auditorium I

16:15 Moderator’s Opening Remarks

Kerry Chester, PhD, Professor, Molecular Medicine, University College London Cancer InstituteKerry Chester, PhD, Professor, Molecular Medicine, University College London Cancer Institute






16:20 Bispecific, Soluble TCR as the Next Therapeutic Platform

Bahija Jallal, PhD, CEO and Director of the Board, ImmunocoreBahija Jallal, PhD, CEO and Director of the Board, Immunocore

Of the two adaptive immunity recognition motifs, only antibodies have been brought to patients. However, antibody therapeutics only recognize 10% of human proteome (surface-expressed). The other motif, T cell receptor (TCR), has potential to unlock 90% of the human proteome, but requires converting a low-affinity, specificity membrane receptor into a soluble therapeutic. IMCgp100, a soluble, TCR bispecific-targeting melanoma, is the most advanced soluble TCR therapeutic in development.

17:20 Attacking Cancer Cell Surfaceomes with Recombinant Antibodies

James A. Wells, PhD, Professor, Departments of Pharmaceutical Chemistry and Cellular & Molecular Pharmacology, University of California,
    San FranciscoJames A. Wells, PhD, Professor, Departments of Pharmaceutical Chemistry and Cellular & Molecular Pharmacology, University of California, San Francisco

The cell surface proteome (surfaceome) is the primary hub for cells to communicate with the outside world. Oncogenes are known to cause huge changes in cells and we find this translates to significant remodeling of the surfaceome. We generate recombinant antibodies to detect and then attack these cells by toxifying the antibodies or recruiting immune cells to kill. I’ll discuss the technologies for surface protein analysis, an industrialized platform for rapid antibody generation using phage display, and using these tool reagents for target validation.

Abcam 18:20 Welcome Reception in the Exhibit Hall with Poster Viewing (Rio Pavilion) 

19:30 End of Day


07:45 Registration (Foyer A) and Morning Coffee (Foyer D)

Auditorium VI

08:30 Chairperson’s Remarks

Charlotte Deane, PhD, Professor of Structural Bioinformatics & Head of Department, Department of Statistics, University of Oxford

08:35 Physicochemical Predictors of Antibody Solution Behavior

Kingsbury_JonathanJonathan Kingsbury, PhD, Head, Developability and Preformulation, Biologics Development, Sanofi

The development of successful high-concentration biologic drugs requires that the therapeutic protein have properties amenable to achieving the target product profile. Selection of molecules that are resistant to unfavorable solution behaviors, such as high viscosity and poor colloidal stability is enabled by developability assessment. A framework for developability is presented, which is centered on assessing the fit to the required dosage form and to the established manufacturing platform. The measurement of molecular and dilute solution properties predictive of high concentration behaviors will be discussed within the context of the underlying solution phenomena and illustrated with examples.

09:05 Developability Assessment to Select Candidates for Clinical Development

Arumughan_AnuAnup Arumughan, PhD, Principal Scientist, Antibody Analytics, Roche

We have developed a highly versatile next generation biologics platform with a number of candidates in clinical development. During lead identification and optimization of candidates, we typically rank molecules based on their potential for successful future development. Such developability assessments provide important information about potential liabilities, e.g., chemical degradation of amino acids or unfavorable CMC properties. We have recently expanded our developability concept to systematically combine in-silico analysis, including pharmacokinetics analysis with biophysical and functional testing. In summary, this concept provides a more holistic picture of a candidate’s fitness for future development.

09:35 Problem-Solving Breakout Discussions*

TABLE 5: Developability of Biologic Drug:  Current Trends, Challenges and Opportunities

Moderator: Johnathan Kingsbury, PhD, Head, Developability and Preformulation, Biologics Development, Sanofi

  • Are there any methods that you're intersted in incorporating into your workflows?
  • What are the biggest unmet needs in the field of developability?
  • How successful have in silico approaches been in predicting liabilities?

TABLE 6: Combining Next-Gen Sequencing and Omics-based Approach for Antibody Optimisation

Moderator: Anup Arumughan, PhD, Principal Scientist, Antibody Analytics, Roche

  • Large-scale B-cell receptor (BCR) repertoire profiling
  • What is the impact of the data mining of Ig-seq data?
  • Hype or Hope or a Game Changer in developing next generation biologics?

10:30 Coffee Break in the Exhibit Hall with Poster Viewing

11:15 Biophysical Screening of Unwanted Protein Interactions

Lorenzen_NikolaiNikolai Lorenzen, PhD, Specialist, Biophysics and Formulation, Novo Nordisk A/S

Stickiness is a critical parameter to measure during developability assessment of antibodies, as it can lead to non-specific interactions, reversible self-association, and aggregation. I will give examples on how we at Novo Nordisk screen for such unwanted protein interactions and how we collaborate with leading academic groups to develop new sophisticated biophysical screening assays.

11:45 Re-Examination of the Hydrophobic Effect at Antibody-Antigen Interfaces

Warwicker_JimJim Warwicker, PhD, Reader, School of Chemistry, University of Manchester

Prediction of developability requires a molecular level understanding of the behaviour of therapeutic proteins. We find that interactions at antibody CDRs challenge current empirical models for the hydrophobic effect. Improvements can be made with introduction of shape-dependence, and this coupling of modern protein science with traditional protein engineering concepts will lead to better predictive models for the biologics community.

UnchainedLabs 12:15 Get the Whole Story on Protein Stability and Aggregation with Uncle

Kevin Lance, PhD, Product Manager, Unchained Labs

Novel protein therapeutics mean that examining thermal stability and non-specific interactions is ever more important in choosing the best formulations for maintaining protein stability and avoiding aggregation.  Uncle’s unique combination of static light scattering, dynamic light scattering, and full-spectrum fluorescence tells the full story of your protein’s conformational and colloidal stability from one small sample.   

creoptix 12:45 Luncheon Presentation I: Keeping Kinetics Real: A New Level of Performance and Flexibility in Drug Discovery

Fabio Spiga, Senior Application Scientist, Application Team Leader Switzerland, Creoptix AG


13:15 Luncheon Presentation II: Choose the New Gold Standard in Protein Stability Characterization

Peter A. Fung, PhD, NanoTemper Technologies


13:45 Dessert Break in the Exhibit Hall with Poster Viewing (Rio Pavilion)

Auditorium VI

14:15 Chairperson’s Remarks

Jim Warwicker, PhD, Reader, School of Chemistry, University of Manchester

14:20 Toward in silico Lead Discovery

Linden_LarsLars Linden, PhD, Director & Head, Protein Biochemistry, Bayer Healthcare AG

  • How will artificial intelligence and machine learning change and impact the way big pharma performs antibody lead discovery and optimization processes in the future?
  • What is already there and what is needed on the journey to in silico drug discovery?


14:50 Deep Learning Enables Therapeutic Antibody Optimization in Mammalian Cells

Mason_DerekDerek Mason, MSc, PhD Candidate, Department for Biosystems Science & Engineering (D-BSSE), ETH Zurich

Deep learning, as part of a family of tools related to machine learning, is an emerging field of information and computer science that uses large data to identify complex relationships. Here, I will describe how we are moving beyond experimental screening by applying deep learning to augment multi-parameter optimization of therapeutic antibodies in mammalian cells.

15:20 Using Structural Information to Aid in silico Therapeutic Design from Next Generation Sequencing Repertoires of Antibodies

Deane_CharlotteCharlotte Deane, PhD, Professor of Structural Bioinformatics & Head of Department, Department of Statistics, University of Oxford

We have built the freely available Observed Antibody Space database of over a billion antibody sequences. Using this data, I will show how predicted structural information can enrich data from next-generation sequencing experiments. In particular, TAP, our novel therapeutic antibody profiler that provides five computational developability guidelines.

RapidNovor 15:50 Antibody Protein Sequencing with Mass Spectrometry

Anthony Stajduhar, Business Development Manager,  Rapid Novor, Inc.

Many applications in antibody engineering require the direct sequence of antibody proteins. At Rapid Novor ( we have developed a robust workflow and routinely sequence antibody proteins. Here we share our success stories, examine common mistakes novices make and present our practices to ensure the correctness of every amino acid. 

Fusion-Antibodies_horizontal 16:05 Affinity Maturation and Optimisation of Trastuzumab using RAMP

Richard Buick, Chief Technical Officer, Fusion Antibodies, plc.

We have used RAMP (Rational Affinity Maturation Platform) to generate an improved version of trastuzumab. The resulting antibody is >3-fold higher affinity and performs equivalently in several analytical assays with no reduction in specificity.

16:20 Refreshment Break in the Exhibit Hall with Poster Viewing (Rio Pavilion)

Auditorium VI

17:00 SELECTED POSTER PRESENTATION: Customized Glycosylation of Therapeutics via a Novel Production Platform

Herwig_StefanStefan Herwig, PhD, Group Leader, Mass Spectrometry, LimmaTech Biologics AG

LimmaTech Biologics utilizes its glycosylation expertise to develop a novel glycoengineering platform for better therapeutics. Scouting of Kinetoplastida led to the identification of a unicellular eukaryote with surprisingly unique N-glycosylation features. We engineered the organism to produce improved therapeutic proteins characterized by custom and homogenous N-glycosylation. Our glycoengineering platform bears the promise of cheaper and faster production. At the same time, it avoids potentially disadvantageous features of mammalian cell production such as glycan microheterogeneity and variable site occupancy. Several proof of concept studies, including EPO and an anti-CD20 antibody, confirm the potential of this novel glycoengineering platform. Next, we will perform mode of action studies of optimized candidate therapeutics to show advantageous glycoengineering effects.


17:30 Begin with Quality in Mind: Identifying CQAs from Early Stage of Product Lifecycle

Shah_ArchanaArchana Shah, Investigator, Analytical and Product Characterisation, Biopharm Process Research, GlaxoSmithKline UK

Identification of Critical Quality Attributes (CQAs) is an imperative step in the development of biopharmaceuticals. The presentation will focus on strategies used to identify CQAs from Discovery stage to Marketing Application. It will give an insight into how early developability screens could be used to get thorough understanding of the product and potential quality attributes affecting the safety and efficacy. Use of structure function studies and risk ranking tool to assess the criticality of quality attributes will also be outlined.

18:00 Importance of Vernier Zone Residues in Antibody Engineering Approaches

Kalyoncu_SibelSibel Kalyoncu, PhD, Research Group Leader, Antibody Engineering Lab, Izmir Biomedicine and Genome Center, Turkey

Vernier zone residues locate in framework regions of antibodies affecting conformations of CDR loops and they are underrepresented in the literature. In this talk, an antibody engineering approach based on vernier zone has been applied to improve biophysical characteristics of an anti-VEGF antibody fragment. According to our preliminary results, solubility and, surprisingly, affinity increased with rationally designed mutation(s) on vernier zone residues. My talk will show one of important ways to improve certain biophysical and affinity characteristics of antibodies.

18:30 End of Optimisation & Developability