Cambridge Healthtech Institute’s 7th Annual
Optimisation & Developability

Selecting and Enhancing the Best Molecule to Move Forward

31 October – 1 November 2016 | EPIC SANA Lisboa Hotel | Lisboa PORTUGAL


In today’s competitive world of myriad biologics formats and the ever-increasing regulatory demands, it is imperative for companies to come up with the best and fastest way to assess a molecule’s developability and manufacturability, optimise candidate molecule’s properties for half-life extension, solubility and stability, and engineer molecules to improve affinity, specificity and efficacy while reducing aggregation. These tools and strategies not only contribute to streamlining efficacy-toxicology evaluation, but also allows for pharmacologically effective, and developable candidates to reach the clinic and successfully to the market.

The 7th Annual Optimisation & Developability conference will bring together these cutting-edge technologies and creative approaches that companies are employing to evaluate, select and optimise the candidates to move forward.

Final Agenda

Day 1 | Day 2 | Speaker Biographies | Download Brochure


Recommended Short Course*

SC2: Mutation and Selection Strategies beyond Affinity Optimisation

*Separate registration required


MONDAY 31 OCTOBER

12:00 Registration


PLENARY KEYNOTE SESSION

13:40 Welcome from PEGS Europe Team

13:45 Chairperson’s Opening Remarks

Ana Barbas, Ph.D., Coordinator, Bayer Satelite Laboratory at iBET, iBET and Bayer Portugal SA

13:50 Biotherapeutic Programs that Re-Direct Cytotoxic Lymphocytes to Cancer Cells

Paul AdamPaul Adam, Ph.D., Executive Director, Immune Modulation and Biotherapeutics Discovery, Boehringer Ingelheim

Cytotoxic lymphocytes such as NK and T cells have the capability to control cancer development and progression. Harnessing this cytotoxic potential with biotherapeutic agents is predicted to become a future pillar of cancer therapy in light of recent clinical successes. This presentation will describe novel biotherapeutics whose mode of action involves the engagement and re-direction of NK and T cells to hematological tumors.

14:30 Antibody-Based Combination Cancer Immunotherapy at Roche pRED

Christian KleinChristian Klein, Ph.D., Distinguished Scientist, Head, Oncology Programs, Cancer Immunotherapy Discovery, Roche Pharmaceutical Research and Early Development, Roche Innovation Center Zurich

This presentation will introduce novel antibody cancer immunotherapies developed at Roche pRED including novel IL2 variant immunocytokines and T cell bispecifics as well as preclinical data for their optimal combination and scheduling.

15:10 Safety Concerns Associated with Immunotherapy and Novel Biotherapeutics and Challenges in Investigating Their Immunotoxicity

Sandra DieboldSandra S. Diebold, Ph.D., Principal Scientist, Immunotoxicology, Biotherapeutics, National Institute for Biological Standards and Control (NIBSC)

The pre-clinical assessment of the risks associated with immunotherapy and novel biotherapeutics is challenging since the bioassays have to be individually tailored to the investigated reagent. The immunotoxic activity and adverse responses that may be observed in patients are depending to a large degree on the mechanism of action of the biotherapeutic. The specific set-up of in vitro assays plus the identification of suitable animal models is critical for obtaining predictive pre-clinical data.


15:50 Refreshment Break in the Exhibit Hall with Poster Viewing


DEVELOPABILITY & MANUFACTURABILITY ASSESSMENT TO GUIDE CANDIDATE SELECTION

16:50 Chairperson’s Remarks

Jonathan Bones, Ph.D., Principal Investigator, National Institute for Bioprocessing Research & Training

16:55 Analytical Strategies to Guide Candidate Selection through Optimization and Developability Assessment

Matthew_TraylorMatthew Traylor, Ph.D., Senior Scientist, Analytical Development, Shire

Selecting and optimizing complex recombinant non-mAb molecules can be extremely challenging. Many of these molecules exhibit complex sets of post-translational modifications (PTM) that afford unique challenges for cell line and/or clone selection. With an increasing number of non-mAb molecules in the pipeline an increased reliance on innovative technologies and approaches are being adopted to increase speed, throughput, and quality of the overall analytical support for candidate selection/optimization.

17:25 Towards a Predictive Manufacturability Assessment Platform for Monoclonal Antibodies

Jonathan Bones, Ph.D., Principal Investigator, National Institute for Bioprocessing Research & Training

17:55 Precisely Controlled, Highly Diverse Gene Mutant Libraries for Synthetic Biology and
Bio-Therapeutic Drug Discovery

Kettleborough_Ross2Ross Kettleborough, Ph.D., European Field Applications Specialist, Twist Bioscience

Effective synthetic libraries are critical for successful discovery and development. Twist’s innovative silicon-based DNA synthesis, reaction volumes are miniaturized by a factor of 1000. By implementing rational design and expertise in synthetic DNA, Twist synthesizes each variant individually. This results in libraries with exceptional representation and diversity and screening efficiency.

18:25 Welcome Reception in the Exhibit Hall with Poster Viewing

19:25 End of Day

 
 

 

TUESDAY 1 NOVEMBER

 

Day 1 | Day 2 | Speaker Biographies | Download Brochure

07:45 Registration and Morning Coffee


IDENTIFYING VARIATIONS AND ASSESSING DEVELOPABILITY

08:30 Chairperson’s Remarks

Mike Molloy, Ph.D., Head, Analytical and Product Characterisation, GlaxoSmithKline

08:40 Fingerprinting Antibody Epitopes: Identifying Even Minor Variations for QC and IP

Michael_SzardeningsMichael Szardenings, Dr.rer.nat., Group Leader, Immunology, Ligand Development, Fraunhofer Institute for Cell Therapy and Immunology

Precise and comparative description of antibody binding sites is important for many reasons. Next generation sequencing in combination with a novel peptide phage display setup allows almost automated in silico analysis of a plethora of binding peptide variants. This routine procedure reveals not only the epitope, it renders in depth details of mimotope variations. These variations are individual signatures not only of different antibodies but also of batch to batch differences.

09:10 New Capillary Electrophoretic Systems for the Affinity Assessment of Protein Mixture Components

Gerhardus_de_JongGerhardus de Jong, Ph.D., Professor, Pharmaceutical Sciences, Utrecht University

We have developed capillary electrophoresis (CE) systems for the study of the affinity of proteins and protein variants to receptors and enzymes. In the first approach, different concentrations of the target protein or ligand are added to the background electrolyte and the affinity of the proteins is assessed by the change of electrophoretic mobility. In the second approach, affinity-specific detection is obtained by the on-line combination of CE and surface plasmon resonance.

09:40 Problem-Solving Breakout Discussions*

Epitope Mapping Approaches

moderator: Michael Szardenings, Dr.rer.nat, Group Leader, Immunology, Ligand Development, Fraunhofer institute for Cell Therapy and Immunology

Analytical Strategies for Developability Assessments

moderator: Mike Molloy, Ph.D., Head, Analytical and Product Characterization, GlaxoSmithKline

  • What are the key analytics that can really differentiate a lead panel (Biophysical vs Physchem analytics)?
  • How important is concentration, do we overlook developability issues by doing analytics at lower concentrations?
  • How important is the material source (HEK vs CHO) and quality of lead panel material?
  • What are the advantages and disadvantages of employing generic methods?

10:40 Coffee Break in Exhibit Hall with Poster Viewing

11:20 Novel Approaches for Rapid Degradation Hotspot Profiling of Biotherapeutic Candidates

Bjoern_HueberBjoern Hueber, Senior Analytical Expert, Novartis Pharma AG

Degradation reactions such as asparagine deamidation and aspartate isomerization can present major risks for the developability of innovative biotherapeutics. Although in silico sequence analysis can help to predict potential degradation sites, time- and labor- intense characterization is still required to identify critical degradation hotspots in biologics lead candidates. This talk presents case studies using novel screening assays combined with a new UPLC-IM-MS platform for rapid and higher throughput monitoring of deamidation or isomerization hotspots.

11:50 Developability Assessment of Complex Biologics

Laurent_LariviereLaurent Lariviere, Ph.D., Principal Scientist, Large Molecule Research, Roche Pharma Research and Early Development, Roche Innovation Center Penzberg, Roche Diagnostics GmbH

Complex biologics such as multispecific antibodies or fusion proteins play an increasingly important role as emerging new pharmaceuticals. In contrast to classic monoclonal antibodies, complex biologics can pose additional developability challenges. The talk will focus on our strategies to design and optimize stable, well-behaved drug candidates.

12:20 New Applications for Array-Based SPR Imaging

Alex_van_der_KooiAlex van der Kooi, Manager, Interaction Laboratory, IBIS Technologies


Nanotemper Technologies12:50 Luncheon Presentation: Explore Prometheus: Biologics Stability Screening Has Never Been Faster, Easier & More Fun

  Breitsprecher_DennisDennis Breitsprecher, Ph.D., Head, Research and Development – Biochemistry, NanoTemper Technologies, GmbH

 

Kern_BeateBeate Kern, Ph.D., Application Specialist, NanoTemper Technologies, GmbH

Prometheus series instruments allow for rapid and precise high-throughput stability screenings, while providing best-in-class high resolution thermal unfolding data for biologics, independent of buffer or protein concentration. It allows for an exact detection of aggregation onset temperatures and aggregation behavior to find the conditions in which the protein is most stable. Explore the Prometheus at the live demo and see how instrument and straightforward software solutions bring a whole new experience to your lab!

13:20 Session Break

14:00 Dessert Break in the Exhibit Hall with Poster Viewing


OPTIMISATION FOR IMPROVED PROPERTIES AND MANUFACTURABILITY

14:30 Chairperson’s Remarks

To be confirmed

14:35 Building a Pipeline in Immuno-Oncology: Bispecific Antibodies from Engineering to Optimized In House Phase One Manufacturing

Stanislas Blein, Ph.D., Head, Antibody Engineering, Glenmark Pharmaceuticals

Glenmark Pharmaceuticals’ BEAT® platform is a robust and versatile bispecific antibody platform based on a unique heavy chain hetero-dimerization technology. We have produced several T-cell recruiting bispecific antibodies against different cancers, with GBR 1302 being our most advanced development candidate. This BEAT® antibody potently re-directs T-cells to HER2 positive cancer cells with an excellent safety-efficacy margin. GBR 1302 was successfully manufactured and will shortly enter clinical phase. Bioprocess and preclinical data will be presented.

15:05 New Strategy for an Old Target: How to Make Extremely Potent Anti-ErbB2 Agents

Rastislav Tamaskovic, Ph.D., Researcher, Department of Biochemistry, University of Zurich

We have recently developed a novel approach employing biparatopic anti-ErbB2 Designed Ankyrin Repeat Proteins (DARPins). By creating an intermolecular trap with DARPin agents, which simultaneously target two distinct ectodomain epitopes of ErbB2, the receptors adopt an inactive conformation with kinase domains incapable of productive interactions. This strategy represents a rational approach to engineer anti-ErbB2 agents inducing cell-specific apoptosis based on a structurally and mechanistically understood principle, without using a toxic payload causing potential off-tumor side effects.

15:35 The Importance of Biophysical Screening in Predicting the Perils of UF/DF

Marisa Barnard, Ph.D., Senior Scientist, Biopharm Molecular Discovery, GlaxoSmithKline

16:05 Extending Drug Half-Life to Achieve Monthly Dosing? The Potential of Veltis® Engineered Albumins for Optimized Dosing

Joanna_HayJoanna Hay, Ph.D., Science Manager, Customer Solution, Albumedix Ltd.

Short circulatory half-life represents a major obstacle for many protein and peptide-based therapeutics. This can be significantly improved by conjugation or fusion to albumin, due to increased size and recycling via the neonatal Fc receptor (FcRn). The increased FcRn affinity of the Veltis® engineered albumins translates to more than doubling of the already long half-life of native albumin. We will describe rationally engineered albumins and their application to improve the pharmacokinetic properties of therapeutic candidates.

16:35 Refreshment Break in the Exhibit Hall with Poster Viewing

17:15 New Solution for Label-Free Biomolecular Interaction Screening

Chiraz Frydman, Ph.D., Product Manager, Horiba Scientific

Label-free biomolecular interaction analysis is increasingly moving towards screening approaches. The XelPleX platform makes it easier and faster than the conventional techniques. Let’s show you how your assay will benefit not only from the advantage of the multiplex but also of the binding affinity determination.

Molecular Devices17:30 Improve Productivity of Cell Line Development Using the ClonePix™ 2 and CloneSelect™ Imagers

Rowe_SarahSarah Rowe, European Application Scientist, Molecular Devices

Molecular Devices offers automated solutions for screening and selection of mammalian clones or microbial colonies. The CloneSelect™ Imager replaces time-consuming, subjective manual inspections of mammalian cells with consistency and objectivity. Re-designed to provide high resolution and fluorescence imaging, all of our CSI models have proven scalable automated use.

17:45 Attribute Tailored Bioprocess Development to Allow ‘Designed In’ Appropriate Product Quality

Karolina_LesKarolina Les, Ph.D., Scientist I, Purification Process Sciences, Biopharmaceutical Development, MedImmune

MedImmune’s pipeline has diversified from predominantly antibodies to include many novel molecules of increased complexity. Development of novel biologics can be challenging and often carry higher risks. These can be addressed by early developability assessments and identification of potential critical quality attributes (pCQA). Case studies highlighting challenges encountered during early development of novel molecules are presented, showcasing how quality can be built into the molecules and bioprocesses in a systematic, science-based manner.

18:15 Preclinical Tools in Formulation Optimization to Improve Biological Performance of Antibodies

Sabine_EichlingSabine Eichling, Ph.D. Student, NBE Formulation Sciences, Abbvie Deutschland GmbH & Co. KG, University of Heidelberg

Formulation development for biologics has primarily focused on the refinement of physical and chemical stability during shelf-life. Effects of formulation composition following subcutaneous injection and reduced bioavailability were usually not considered. The addition of biological read out parameters enables further improvement in the antibody transport to the target tissue. We develop translatable models to understand the transport of antibodies following subcutaneous injection and predict the effect of the formulation on the bioavailability.

18:45 End of Optimisation & Developability



Day 1 | Day 2 | Speaker Biographies | Download Brochure