Cambridge Healthtech Institute’s 6th Annual

Characterization of Biotherapeutics
( 生物学制剂表征 )

Improving Prediction, Screening, and Characterization of New Biologics


Part of the Analytics & Impurities pipeline

The popular 6th Annual Characterization of Biotherapeutics conference will bring together leading scientists from the biopharmaceutical industry, academia, and government to discuss case studies, new technologies, assay on analytical development and characterization of mAbs, ADCs, bispecifics, and other novel protein formats, biosimilar. Some of the hot topics for discussion this year will include regulatory expectations and developability of new product formats, cell and gene therapy products, biosimilars, high-throughput analytics, multi-attribute methods, glycosylation/post-translational modifications and biophysical assays, and more.

Final Agenda



4:00 - 6:00 pm Pre-Conference Registration


7:00 am Registration and Morning Coffee

Challenges, Developability, Risk Assessment, and Strategies

9:00 Organizer’s Welcome Remarks

Nandini Kashyap, Conference Director, Cambridge Healthtech Institute

9:05 Chairperson’s Opening Remarks

Suzanne D’Addio, PhD, Principal Scientist - Discovery Pharmaceutical Sciences, Merck & Co., Inc.


9:10 Developability Assessment to Select Candidates for Clinical Development

Arumughan_AnupAnup 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.

9:50 Analytics in the Development of Biosimilars and Beyond

Robert Mayer, PhD, Senior Fellow, Novartis - Global Drug Development, Technical Research & Development, Sandoz GmbH

Analytical characterization is one of the key pillars for biosimilars development. With the help of case studies, we will demonstrate the powerfulness of analytical methods. In one case study, the elucidation of structure-function relationship will be addressed. In another case study, an innovative approach for the glycan analysis in PK studies will be shown to evaluate the (possible) impact of individual N-glycan species onto clearance. Furthermore, analytical challenges and requirements for the development of “fit-for-purpose” analytical methods will be briefly addressed.

10:20 Networking Coffee Break

10:45 Antimicrobial Excipient-Induced Reversible Association of Therapeutic Peptides in Parenteral Formulations

D'Addio_SuzanneSuzanne D’Addio, PhD, Principal Scientist - Discovery Pharmaceutical Sciences, Merck & Co., Inc.

The high potencies and longer half-lives of therapeutic peptides have given rise to multiuse injectable dosage forms that enable less frequent dosing and patient self-administration, but required antimicrobial preservatives can impact other attributes of protein and peptide formulations. To understand molecular mechanisms of peptide-preservative interactions influencing solution-phase self-association, we investigated the interactions of commonly used antimicrobial preservatives with an acylated peptide. We have demonstrated a reversible association phenomenon granting new insights into mechanisms by which peptides can interact with excipients. These findings have practical implications for drug product formulation development.

11:15 Multi-Specific Agent to Overcome Potential Resistance to Influenza

Chiu_MarkMark Chiu, PhD, Associate Director, BioTherapeutics Analytical Development, Janssen Research & Development LLC

A multi-specific agent was designed to target multiple epitopes on pan-influenza strains. The engineering to prepare the relevant therapeutic product profile involving viral neutralization, immune effector function, and optimal pharmacokinetic profile will be presented.

11:45 Comparative Evaluation of Chelating Agents to Prevent Polysorbates and API Degradation in Biologic Formulations

Sanket Patke, PhD, Senior Scientist, Biologics Drug Product Development, Sanofi

EDTA and other chelators are used in several products, few of which are biologics. Their need, pros, and cons as excipients are, however, still poorly understood. In this case study, a head-to-head comparison of EDTA with other chelating agents is presented, including recommendations for their correct use in the formulation of protein-based therapeutics.

12:15 pm Selected Poster Presentation: Development of Standards for Cation exchange chromatography Column Qualification

Jie (Amy) Liu, Scientist IV, Biologics & Biotechnology Laboratory Global Biologics

USP has sponsored several roundtables with stakeholders to identify challenges in biologics development that could be alleviated with standards. Standards for qualification of cation exchange columns were ranked as high priority. We evaluated three new USP monoclonal antibody standards under development using pH gradient and salt gradient CEX methods on columns from different vendors to support selection of a candidate for further development of the CEX column qualification standard.

12:45 Session Break

12:55 Luncheon Presentation to Be AnnouncedSciex

Mass Spectrometry Analysis

2:00 Chairperson’s Remarks

Elizabeth M. Topp, PhD, Dane O. Kildsig Chair and Department Head, Department of Industrial and Physical Pharmacy, Purdue University

2:05 Diverse Samples, Fast Turnaround: Providing Meaningful Data in Biotherapeutic Early Discovery

Thompson_Alayna_GeorgeAlayna George Thompson, PhD, Senior Scientist I, Drug Discovery Science & Technology, AbbVie

Characterizing early discovery biologics presents challenges related to the diversity of molecules and formats coupled with the need for quick data turnaround. To address these challenges, we expanded a walk-up mass spectrometry analysis workflow for purified proteins to include characterization (protein identification, post-translation modifications, and proteolysis) of proteins during transient cell expression. These analyses provide business impact by empowering data-driven decisions for biologics production.


2:35 Solid-State Hydrogen Deuterium Exchange (ssHDX-MS): High-Resolution Characterization of Lyophilized Biotherapeutics

Elizabeth M. Topp, PhD, Dane O. Kildsig Chair and Department Head, Department of Industrial and Physical Pharmacy, Purdue University

More than 40% of biologics approved in the last ten years are marketed in lyophilized form, but the factors controlling stability in these amorphous powders are poorly understood. ssHDX-MS is a novel analytical method that characterizes protein structure and matrix interactions in the solid state with peptide level resolution. Results of ssHDX-MS analysis have been shown to be highly correlated with protein stability on long-term storage. This presentation reviews the ssHDX-MS method and presents new results from ongoing studies of exchange kinetics and mechanisms.

3:05 Find Your Table and Meet Your BuzZ Session Moderator

3:15 BuzZ Sessions with Refreshments

Join your peers and colleagues for interactive roundtable discussions.

Click here for more details

4:30 Characterization of Glycan Heterogeneity for mAb based molecules using High Resolution and Single Ion Monitoring Mass Spectrometry Techniques

Sheila Mugabe, MSc, Scientist, MacroGenics, Inc.

Monoclonal antibodies and novel bispecific DART® molecules are being developed for a variety of indications including immune-oncology. This presentation discusses the analysis of glycan heterogeneity profiles for such molecules using High Resolution and Single Ion monitoring mass spectrometry techniques.  High throughput characterization approach during process development will be discussed.

Process Characterization and Control

5:00 Computational Methods for Cell Culture Media Optimization and Product Quality Control

Chauhan_GauravGaurav Chauhan, MS, Associate Principal Scientist, Biologics Process Research and Development, Merck & Co., Inc.

Biologics development leading to approval can take decades. Acceleration is desired to bring safe and efficacious drugs to patients as early as possible. One research focus is to reduce development time for cell culture process development and optimization. Strategies will be shared that cover optimizing cell culture media using Orthogonal-Partial Least Squares (OPLS) regression and modulating glycosylation by altering small molecule compound concentrations based on the Concentration Impact Factor.

5:30 Risk Assessment of Formulation Attributes and Feasibility for Alternative Routes of Administration of Biologics during the Developability Stage

Yingkai Liang, PhD, Senior Scientist, Discovery Pharmaceutical Sciences, Merck & Co., Inc.

While intravenous administration is a generally well-accepted route of administration for biologicals, increasing market competition and desire for local therapy have renewed interest in the delivery of proteins by alternative routes of administration. This presentation will cover the assessment of formulation parameters in the context of optimizing developability properties of proteins intended for administration by alternate routes of delivery.

6:00 - 7:15 Welcome Reception in the Exhibit Hall with Poster Viewing

7:15 Close of Day



8:15 am Registration and Morning Coffee

High-Throughput Screening, Assays, and Other Analytical Considerations

8:45 Chairperson’s Remarks

Peter Schurtenberger, PhD, Professor, Department of Chemistry, Lund University

8:50 Size and Weight Are Two Related but Different Fundamental Measurables

Hayes_DavidDavid Hayes, PhD, Biophysics Consultant, International Solidarity of Scientists

Analytical methods and assays seldom measure product quality attributes directly, but they quantitate attribute levels through a related signal. Speaking of the various methods that quantitate aggregation, the terms such as size, weight, and molecular weight are conflated to mean the same thing. Understanding the strengths and weaknesses of aggregation assays requires more rigorous mathematical definition of measurables.

9:20 Biopharm Critical Quality Attributes (CQAs): It is When Product Analytics, Process, and Clinical Outcomes Connect

Wasfi AlAzzam, PhD, Chief Scientific Officer, TechnoPharmaSphere LLC 

Analytical methods have been playing a major role in creating in vitro and in vivo biopharm product characterization packages. Compiling both sets of data helps in-depth understanding of product’s quality attributes (QA) and filters some to figure the product’s CQAs. It is proven that some CQAs have impact on the product’s biological and clinical profiles. Biopharm industry is now revising their CMC strategy to accelerate product development. This talk will connect analytical, CQAs, and clinical outcomes. 

9:50 Coffee Break in the Exhibit Hall with Poster Viewing

11:00 High-Throughput Biophysical Characterization of New Classes of Antibodies

Mitra Mosharraf, PhD, HTD Biosystems, Inc.

In this talk, characterization of various biomolecules such as mAb, fusion proteins, Fab and bispecifc antibodies will be discussed. We will showcase use of high-throughput technologies such as nDSF, MST, DLS, and protein chip bioanalyzer in characterization of the conformational and colloidal stability of these molecular entities alone and in combination.

11:30 Characterizing Protein Interactions and Solution Viscosities Using Advanced Scattering Tools

Schurtenberger_peterPeter Schurtenberger, PhD, Professor, Department of Chemistry, Lund University

Measuring and predicting solution viscosity is essential in formulating biopharmaceuticals. We show how we can use a combination of advanced characterization techniques, such as small-angle neutron (SANS) and X-ray scattering (SAXS) to characterize protein interactions and microrheology experiments to assess and predict solution viscosity in concentrated solutions

of biopharmaceuticals. We will discuss recent advances in protein microrheology using either optical or microfluidics approaches.

biotechne12:00 pm Influences of Sample Preparation and Data Evaluation on CE-SDS and SDS-PAGE

Wiesner_RebeccaRebeca Wiesner, PhD, Scientist, Technische Universität Braunschweig, Institute of Medicinal and Pharmaceutical Chemistry

Gel electrophoresis (SDS-PAGE) is the most common approach for molecular mass determination (MW) of proteins. Results are compared to CE-SDS (Maurice, ProteinSimple) and Simple Western (WES, ProteinSimple) concerning precision and accuracy of MW using nine typical model proteins (7-180 kDa) and Matuzumab (IgG antibody). Various conditions of sample preparation e.g. different temperature conditions and reducing agents and the influence of data evaluation by comparison of different molecular weight markers were investigated.

:30 Session Break

12:40 Luncheon Presentation to be Announced

1:10 Close of Characterization of Biotherapeutics Conference


5:45 - 8:45 Recommended Dinner Short Courses*

SC3: Structure-Based Optimization of Antibodies

Traian Sulea, PhD, Principal Research Officer, Human Health Therapeutics, Biotechnology Research Institute, National Research Council Canada


SC5: Protein Aggregation: Mechanism, Characterization, and Consequences


Thomas Laue, PhD, Professor Emeritus, Biochemistry and Molecular Biology; Director, Biomolecular Interaction Technologies Center (BITC), University of New Hampshire

Kevin Mattison, PhD, Principal Scientist, Malvern Pananalytical, Inc.

*Separate registration required


* 活动内容有可能不事先告知作更动及调整。

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