Cambridge Healthtech Institute’s Third Annual
Characterization of Biotherapeutics
Improving Prediction, Screening and Characterization of New Biologics
January 9-10, 2017 | Hilton San Diego Bayfront | San Diego, CA
New biotherapeutics formats are flooding the discovery and development pipelines and with this comes an increasing need for better and faster characterization tools and strategies, and improved biomolecular and biophysical assays for the new biotherapeutics.
The Third Annual Characterization of Biotherapeutics conference presents new tools, strategies and case studies on analytical development and characterization of mAbs, ADCs, bispecifics, and other novel protein formats.
We invite you to present a poster and attend to join colleagues in this discussion of the key challenges and solutions improving prediction, screening and characterization of new biologics.
MONDAY, JANUARY 9
7:30
am Conference Registration and Morning Coffee
9:00 Welcome by Conference Organizer
Nandini Kashyap, Conference Director, Cambridge Healthtech Institute
9:05 Chairperson’s Opening Remarks
Shrikant Deshpande, Ph.D., Senior Director, Protein Chemistry, Biologics Discovery California, Bristol-Myers Squibb Co.
Keynote Presentation
9:10 Understanding Chemical Liabilities in Antibody Lead Selection
Shrikant Deshpande, Ph.D., Senior Director, Protein Chemistry, Biologics Discovery California,
Bristol-Myers Squibb Co.
Chemical liabilities such as deamidation, and oxidation in an antibody sequence can alter the structure and activity of the lead molecule. So, it is important and necessary to assess and understand the risks they pose in the CMC as well as therapeutic
setting. This presentation explores chemical liability risks in lead selection process and provides case studies that provide risk mitigation strategies.
9:50 Biophysical Characterization to Enable the Formulation Development of Multi-Dose Aggregation-Prone Peptide Conjugates
Jingtao Zhang, Ph.D., Principal Scientist, Pharmaceutical Sciences, Merck Research Laboratories
The presentation will focus on the characterization of reversible and irreversible fibril aggregates in peptide formulations, biophysical assays that that guide AME study design, and high resolution biophysical study to enable insights in formulation
stabilization mechanism. Overall considerations on the development of multi-dose peptide formulations as well as strategies in overcoming the challenges will also be highlighted.
10:20 Coffee
Break
10:45 Biosimilars – The Analytical Challenge
Gerard Powell, Ph.D., Senior Principal Specialist, Product Characterisation, Analytical Sciences, Allergan Biologics Ltd.
An overview of biosimilars and biosimilar development with an emphasis on the unique analytical challenges they present. I will discuss strategies for establishment of analytical similarity and illustrate these with case study data generated on real
biosimilar projects.
11:15 Top-Down LC-MS Analysis of Filgrastim and Related Impurities
Dennis Gessmann, Ph.D., Associate Research Scientist, Analytical R&D, Biosimilars Pharmaceutical Sciences, Pfizer, Inc.
Detailed characterization is required to establish biosimilar products are safe and effective. Top-down mass spectrometry was used to identify filgrastim and related impurities that are quantitated by a RP-HPLC assay. Forced degraded samples were
used for the analysis. Results are consistent with known filgrastim degradation pathways.
11:45 Analytical Comparability and Characterization of a Non-Covalent Heterodimer Biotherapeutic
Justin Prien, Ph.D., Associate Director, Analytical Development, Shire
This presentation discusses the analytical comparability for a non-covalent heterodimer biotherapeutic performed to facilitate product developmental continuity. The analytical comparability strategy was designed to assess the similarity of the potential
critical quality attributes and mitigate false negative results. At the development stage comparability can be challenging due to analytical method immaturity, the extent of process and product knowledge, and a limited number of manufacturing
batches from the different processes.
12:15 pm Development of a High-Throughput Formulation Screening Platform for Therapeutic Monoclonal Antibodies
Yunsong (Frank) Li, Principal Scientist, Analytical and Formulation Development, Cook Pharmica
12:45 Session Break
1:00 Luncheon Presentation: Making Cancer Go BOOM: Development of Smart Bombs as Potential Cancer Therapeutics using Surface Plasmon Resonance
Paul Belcher, Ph.D., Functional Leader, Biacore™, GE Healthcare
Cytotoxic drugs are broadly used to treat hematological diseases and solid tumors, but often cause adverse events. Efforts at improving the quality of treatment of cancer patients has focused on maintaining the effectiveness of the chemotherapeutic
drugs whilst minimizing the cytotoxicity. Antibody drug conjugates (ADC’s) combine the targeting capabilities of the antibody with the cancer killing capabilities of the cytotoxic drug. This presentation will highlight the development
of ADC’s for Gynecological Cancer using Biacore™ SPR.
2:00 Chairperson’s Remarks
Marina Kirkitadze, Ph.D., MBA, Deputy Director, Analytical R&D Biochemistry, Sanofi Pasteur
2:05 Characterization of Aluminum Adjuvant and Adsorbed Proteins
Marina Kirkitadze, Ph.D., MBA, Deputy Director, Analytical R&D Biochemistry, Sanofi
Pasteur
This presentation summarizes the characterization of the physicochemical and compositional properties of vaccine components: aluminum-based adjuvant and adsorbed protein antigens. Particle size distribution was measured by Laser Diffraction, whereas Raman and Fourier Transform Infrared spectroscopies were used to analyze the compositional properties of aluminum-based adjuvant and adsorbed protein antigens.
2:35 Role and Relationship between Biophysical and Analytical Data in Formulation Development and Comparability Assessments
Haripada Maity, Ph.D., Research Advisor, Formulation Development, CMC Development, Eli Lilly and Company
Biophysical and analytical measurements are often performed for formulation development and during comparability assessment of protein therapeutics. The roles and relationship of these data and how they relate to method sensitivity, analysis,
and interpretation is an im-portant avenue of discussion. This presentation will discuss the utility of these multidimen-sional approaches and the connectivity of these data in terms of thermodynam-ic/conformational stability and kinetic
stability of protein.
3:05 Get the Full Picture and Predict Biotherapeutics Stability with nanoDSF
Charles Heffern, Application Specialist, NanoTemper Technologies
To support scientists on their cumbersome way to the perfect biotherapeutics product in terms of developability and long-term stability, we designed the Prometheus instruments for rapid and precise high-throughput stability screenings
using nanoDSF. Get introduced to case studies with major biopharmaceutical companies and learn how they revolutionized development of biotherapeutics.
3:20 Refreshment Break in the Exhibit Hall with Poster Viewing
4:00 Comprehensive Characterization of Product Variants and Higher-Order Structure of Monoclonal Antibodies with Case Studies
Renata Varga, Ph.D., Characterization Scientist, Analytical Sciences, Global
Biological CMC, Teva Pharmaceuticals
Characterization of monoclonal antibodies under development is a key step to better understand the properties and behavior of that new mAb, especially for product variants. After a critical quality attribute assessment, the anticipated
variants can be thoroughly characterized based on a well-designed plan. Characterization data on mAb size variants, aglycosylated species, and isoforms (charge, disulfide) by several analytical methodologies will be presented.
4:30 Therapeutic Protein Characterization for Process Development – a Case Study
Quanzhou Luo, Ph.D., Senior Scientist, Process Development, Amgen
Although therapeutic proteins are relatively stable, they can undergo a variety of degradations during manufacturing, formulation and storage. It is, therefore, very important to characterize the biophysical and biochemical properties
of the degradations to better assess their safety and efficacy. With the implementation of the quality by design (QbD) concept to drug devel-opment, monitoring product quality attributes (PQAs) during process development has be-come
increasingly critical.
5:00 PANEL DISCUSSION: Challenges in Implementing New Assays, Automation and Miniaturized Assay
Moderator:
Marina Kirkitadze, Ph.D., MBA, Deputy Director, Analytical R&D Biochemistry, Sanofi Pasteur
Panelists:
Haripada Maity, Ph.D., Research Advisor, Formulation Development, CMC Development, Eli Lilly and Company
Stefan Duhr, Ph.D., CEO, NanoTemper Technologies
Renata Varga, Ph.D., Characterization Scientist, Analytical Sciences, Global
Quanzhou Luo, Ph.D., Senior Scientist, Process Development, Amgen
6:20-7:30 Welcome Reception in the Exhibit Hall with Poster Viewing
7:30 Close of Day
TUESDAY, JANUARY 10
8:00
am Conference Registration and Morning Coffee
8:30 Chairperson’s Remarks
Audrey Hanard, MSc., Spin-off Developer, Structure and Function of Biological Membranes, Université libre de Bruxelles
8:35 Assessing the Higher-Order Structure of Therapeutic Monoclonal Antibodies by NMR Spectroscopy
Yves Aubin, Ph.D., Research Scientist, Regulatory Research Division, Health Canada
Monoclonal antibodies (mAbs) are the fastest growing class of therapeutic protein. In addition, a number of mAb products have lost or will lose patent protection. Here we will present our latest efforts in applying NMR spectroscopy
to obtain high-resolution structural information to facilitate the assessment of this critical quality attribute. The approach is applicable in the context of a comparability exercise, whether it is for innovator or biosimilar
products alike.
9:05 Use of Steady-State and Time-Resolved Fluorescence Spectroscopy for Higher-Order Structure Characterization
Michael Ignatov, Ph.D., Senior Scientist, Biologics Development Analytical Sciences, Allergan,
Plc
Intrinsic tryptophan fluorescence serves as a highly sensitive indicator of the higher-order structure of proteins. Tryptophan fluorescence properties are extremely sensitive to the local environment around tryptophan and solvent accessibility.
Differences in the fluorescence properties of proteins are measured to monitor the changes in the higher-order structure. Effect of chemical modifications, chemical unfolding, thermal unfolding, etc. on the spectral properties
and fluorescence lifetimes is assessed using several model proteins.
9:35 Antibody Protein De Novo Sequencing with LC-MS/MS
Mingjie Xie, Co-founder, CEO, Rapid Novor Inc
Many applications in antibody engineering require the direct sequencing of antibody proteins. At Rapid Novor (rapidnovor.com) we have developed a robust workflow and routinely sequenced antibody proteins. Here we share the success
experiences, examine common mistakes novices make, and present our practices to ensure the correctness of every amino acid.
9:50 Coffee Break in the Exhibit Hall with Poster Viewing
11:00 FTIR Spectroscopy as a Multi-Parameter Analytical Tool for Comparability Testing and Stability Studies of Therapeutic Proteins
Audrey Hanard, MSc., Spin-off Developer, Structure and Function of Biological Membranes, Université libre de Bruxelles
Harnessing the strengths of infrared spectroscopy and recent improvements in chemometrics, new analytical methods have been developed to study the stability and perform comparability studies of therapeutic proteins. The presentation
will demonstrate the feasibility, through one quick and direct measurement, to simultaneously obtain information concerning four key characteristics of therapeutic proteins: (i) structural integrity, (ii) quantification of post-translational
modifications, (iii) overall protein concentration and (iv) quantification of key excipients.
11:30 Software Platform for Therapeutic Protein Characterization with LC-MS
Lin He, Ph.D., Senior Application Scientist, Bioinformatics Solutions, Inc.
Advancements in mass spectrometry have given us the capability to well-characterize therapeutic proteins. The challenge, however, is the ability to process combined-datasets which are derived by various methods, and efficiently report
this information. In this study, we will look the software platform, PEAKS AB, which presents the following functions for protein characterization: (1) Protein de novo sequencing with LC-MS/MS of multiple-enzyme digestion; (2)
PTM quantification with label-free approach; (3) Protein sequence confirmation with peptide mapping and intact protein analysis.
12:00 pm Title to be Announced
Satish Singh, Ph.D., Head, Drug Product Process Development, Lonza AG
12:30 Enjoy Lunch on Your Own
1:15 Close of Conference