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Cambridge Healthtech Institute’s Inaugural
Characterization of ADCs, Bispecifics and New Biotherapeutics
Improving Prediction, Screening and Characterization of New Biologics
January 19-20, 2015


With the wave of new biotherapeutics formats flooding the discovery and development pipelines, there is an increasing need for better and faster characterization tools and strategies, and improved biomolecular and biophysical assays for the new biotherapeutics. The new Characterization of ADCs, Bispecifics and New Biotherapeutics conference presents high-level case studies and strategies on improving characterization of ADCs, bispecifics and novel protein formats. Cutting-edge tools, research findings and unpublished data will be featured at this forum.

We invite you to join colleagues in this discussion of the key challenges and solutions improving prediction, screening and characterization of new biologics, and see how experts like you are developing scientifically sound formulations of new biotherapeutics.


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Analytical Control Strategy for Novel Complex Recombinant Biotherapeutics: Begin with the End in Mind
Johnson Varghese, Ph.D., Senior Director, Head of Analytical Development, Shire HGT 


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Final Agenda 


SUNDAY, JANUARY 18


4:00-5:00 pm Short Course Registration

5:00-8:00 Pre-Conference Dinner Short Courses (More Details >>)


4:00-8:00 Main Conference Registration


MONDAY, JANUARY 19

7:30 am Conference Registration and Morning Coffee


Developing a Successful Analytical Strategy for Candidate Selection and Optimization

9:00 Chairperson’s Opening Remarks

Johnson Varghese, Ph.D., Senior Director, Head of Analytical Development, Shire HGT


Keynote Presentations

9:10 Regulatory Perspective on Challenges in ADC Development

Wen Jin WuWen Jin Wu, M.D., Ph.D., Senior Investigator, Division of Monoclonal Antibodies, Office of Biotechnology Products, OPS-CDER-Food and Drug Administration

The unique properties of ADCs create technical challenges that require careful CMC considerations. With the increase in ADC IND submission and recent approval of ADC products (Adcetris and Kadcyla), FDA has gained the in-depth knowledge regarding ADC development programs. This presentation will discuss FDA experience with ADC development and regulatory challenges, with special focus on CMC. A strategy for the development of the next generation of ADCs will also be discussed.

9:50 High-Throughput Developability Screening Methods Targeting Antibody Self/Cross Interaction

Eric KraulandEric Krauland, Ph.D., Senior Director, Antibody Discovery and Optimization, Adimab, LLC

Developability issues, such as aggregation, low solubility, high viscosity and poor pK can be tracked to antibody self or cross interaction. The talk will review high-throughput methods to screen hundreds to thousands of antibodies, such as IgGs and bispecifics, within a single day to be compatible with early stage antibody discovery. Selecting for developability properties along with target biology in the earliest discovery stages aims to improve the efficiency of the overall development process.


10:20 Coffee Break

10:45 Analytical Characterization of Biologics for Candidate Selection and Optimization: Strategies and Case Studies 

Guodong ChenGuodong Chen, Ph.D., Senior Principal Scientist, Bioanalytical and Discovery Analytical Sciences, Research and Development, Bristol-Myers Squibb Co.

Since the introduction of the first recombinant DNA-derived protein insulin in the 1980s, antibody market has shown a steady growth. However, there are significant analytical challenges in the characterization of antibodies. This presentation will highlight current challenges and new enabling analytical techniques for the selection and optimization of antibody candidates.

11:15 Challenges and Strategies for Establishing an Analytical Control Strategy for Novel Complex Recombinant Biotherapeutics

Johnson VargheseJohnson Varghese, Ph.D., Senior Director, Head of Analytical Development, Shire HGT

Establishing an analytical control strategy for recombinant non-mAb therapeutics that exhibit complex sets of post-translational modifications and size distributions can be extremely challenging due to lack or little prior knowledge regarding the impact of these attributes on safety and efficacy. In this presentation, strategies for developing a control strategy based on criticality assessments of product attributes from early to late stage development for novel molecules will be described.

Antibody-Drug Conjugates (ADCs): Characterization, Developability and Control Strategy

11:45 Light-Induced Degradation of Antibodies and Antibody-Drug Conjugates

Christian_SchöneichChristian Schöneich, Ph.D., Professor and Chair, Pharmaceutical Chemistry, University of Kansas

Antibody-drug conjugates (ADCs) provide a promising approach to deliver large payloads to specific cell populations. However, chemical and physical instability may arise from the exposure of ADCs to light, as several ADCs contain drug conjugates, which may act as photosensitizer, and/or drug conjugation may trigger photosensitivity in general. This talk will focus on light-induced photodegradation of ADC mimics, designed to evaluate the light-sensitivity and degradation mechanisms of ADCs.

Wyatt12:15 pm Molar Mass, Size and Interactions: Light Scattering Tools for Essential Biophysical Characterization

Some_DanielDaniel Some, Ph.D., Director, Marketing, Principal Scientist, Wyatt Technology Corporation

Biophysical techniques based on static and dynamic light scattering address many of the key analytical challenges in biotherapeutic R&D, from early candidate selection through scale-up, formulation, characterization and comparability studies. This seminar will review light scattering technology and instrumentation, then present select examples illustrating how Wyatt's light scattering solutions facilitate rapid and effective development of biologics including mAbs, ADCs, PEGylated and other proteins.

12:45 Enjoy Lunch on Your Own


ADCs: Characterization, Developability and Control Strategy Continues...

2:00 Chairperson’s Remarks

Shrikant Deshpande, Ph.D., Senior Director, Protein Chemistry, Biologics Discovery California, Bristol-Myers Squibb Co.

2:05 Challenges in ADC Characterization

Shrikant DeshpandeShrikant Deshpande, Ph.D., Senior Director, Protein Chemistry, Biologics Discovery California, Bristol-Myers Squibb Co.

ADC characterization is a critical component of ADC research and development. Antibody characteristics, the structure of payloads - linkers and conjugation technologies influence the characterization of ADCs. In addition to QC requirements, ADC characterization will help explain the observed biological results in preclinical studies and provide guidance for product release specifications. In this presentation, challenges in the ADC characterization and translation of characterization strategies into product release assays will be discussed.

BioTools2:35 Cutting Edge Vibrational Spectroscopy for Protein Therapeutics

Dukor_RinaRina K. Dukor, Ph.D., President , CEO, BioTools, Inc.

The use of FT-IR spectroscopy as a probe of secondary structure is now widespread throughout the biopharmaceutical industry. More recently, ROA (Raman Optical Activity) has been shown to indicate differences when none are observed with any other spectroscopic technique. In this presentation, we will discuss advances in four forms of vibrational spectroscopy as applied to structural studies of proteins.

3:05 Physical Characterization of ADC with Different Loadings

Jianxin Guo, Principle Scientist, Biotherapeutics Pharmaceutical Sciences, Pfizer, Inc.

Conjugation of an antibody to a drug can produce heterogeneous species that may have different physical stabilities and safety profiles. This talk will illustrate the effect of loading profiles on the physical characteristics and aggregation propensity of an ADC conjugated by thiol-maleimide chemistry. The application of biophysical techniques on the evaluation of hydrophobicity and structural stability will be elaborated.

3:35 Late Breaking Presentation

3:50 Refreshment Break

4:15 Addressing Product Heterogeneity Challenges in ADC Biotherapeutics: Case Studies

Nomalie Jaya, Ph.D., Senior Scientist, Seattle Genetics, Inc.

Antibody-drug conjugates (ADCs), produced through the chemical linkage of a potent small molecule cytotoxic agent(drug) to a monoclonal antibody (mAb) are likely to have product heterogeneities associated with drug- linker attachment site andconjugation process that are different than the typical heterogeneity observed in mAbs.  ADC heterogeneity can be characterizedand controlled through identification of critical quality attributes (CQAs), implementation of appropriate process controls and analytical tools. Here we discuss two case studies highlighting the implications of heterogeneities in an ADC analytical profile used for productquality monitoring; 1) Drug-linker charge anddistribution oncharge based purityand 2) ADC modality on size heterogeneity as measured under native and denaturing conditions.

4:45 Characterization of Antibody-Drug Conjugates and Control Strategies for Small Molecule Impurities

Juma BridgewaterJuma Bridgewater, Ph.D., Scientist III, Analytical and Pharmaceutical Sciences, ImmunoGen, Inc.

The challenge of characterizing ADCs is compounded by small molecule impurities present with the cytotoxic agent. Different control strategies are used for impurities based on their potential pharmacological effect, degree of protein modification and likelihood of clearance during processing. This talk describes different impurity control strategies and the characterization and release test methods that support them.

5:15 Biological and Analytical Characterization of ADCs Based on RNA Polymerase II Inhibiting Toxins

Andreas_PahlAndreas Pahl, Ph.D., CSO, Heidelberg Pharma

Toxic warheads of today’s ADCs are exclusively based on compounds acting on microtubules or DNA and seem to suffer from limitations in certain cancer indications and tumor cells. This talk will discuss a new generation of ADCs based on the toxin amanitin, a highly effective inhibitor of the eukaryotic RNA Polymerase II. This presentation will summarize the current status of this new payload and present a showcase about the biological and analytical characterization of amanitin based ADCs.

 

ProteinSimple Large

5:45-7:00 Welcome Reception in the Exhibit Hall with Poster Viewing



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