Cambridge Healthtech Institute 第5回

Characterization of Biotherapeutics
( 生物学的製剤の特性評価 )




Final Agenda



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


7:00 am Registration and Morning Coffee


9:00 Welcome by Conference Organizer

Nandini Kashyap, Conference Director, Cambridge Healthtech Institute

9:05 Chairperson’s Opening Remarks

Kelly Loyet, PhD, Senior Scientist, Biochemical and Cellular Pharmacology, Genentech


9:10 Antibody Therapy: From Substitution to Immunomodulation and Monoclonal Immunotherapy

Paul Imbach, MD, Professor, Ped. Oncology/Hematology, University of Basel, Switzerland

Polyvalent antibody concentrate substitutes patients with immune deficiency and severe infection and synergistically immunomodulates the disturbed immune system with no or mild adverse effects in patients with autoimmune disease. While monoclonal immunotherapy may evoke severe adverse effects such as immune deficiency, infection, autoimmune or oncologic diseases and others, the question arises whether to combine monoclonal with polyvalent antibody therapy for avoidance of severe adverse effects and for treatment of the loss of tolerance – the common cause of autoimmunity and cancer.

9:50 Structure and Function Relationships: Link Control Strategy to CQAs

Jane (Xiaoyao) Xiao, PhD, Senior Director, Biologics Characterization, Axcel BioPartners

Structure and function relationships are essential to a risk assessment for ranking and prioritizing quality attributes. The development of a robust control strategy in manufacturing process can be challenging due to the structural and functional complexity of therapeutic proteins. The presentation will focus on the approaches in establishing structure-function relationships to manage CQAs and to develop a control strategy, including aggregation, oxidation and glycan structures relationship with FcRn binding potency, proliferation potency and cytotoxicity bioactivity.

10:20 Networking Coffee Break

10:45 Approaches to Understanding the Manufacturability of Monoclonal Antibodies

Michael Anyadiegwu, PhD, Senior Scientist, Downstream Processing, Centre for Process Innovation Ltd., National Biologics Manufacturing Centre

A short list of 50 monoclonal antibody sequences was selected based on experimental data from 200 monoclonal antibodies sequences. These 50 molecules covered a range of titres and quality attributes. Using a standard CHO USP and DSP platforms, the 50 molecules were manufactured and purified to provide material for measurement of biochemical, biophysical and immunological information. This presentation provides an update on the project outputs and progress to linking biochemical and quality data to sequence and structural liabilities.

11:15 Sponsored Presentation (Opportunity Available)

11:45 Glycan Characterization Strategies to Guide Early Biotherapeutic Development

Nathan Brown, PhD, Senior Scientist III, Global Biologics, AbbVie, Inc.

Post translation modifications (PTMs) can significantly alter protein function and disposition and, therefore, necessitate detailed analytical characterization of protein therapeutics as well as the targeted proteins. One category of PTMs of interest, importance and complexity is protein glycosylation. Here, we present strategies utilizing multiple, orthogonal approaches, to characterize glycan micro- and macro-heterogeneity, guiding early development and providing increased understanding of novel biologics and their protein targets.

12:15 pm Cutting-Edge Capillary Electrophoresis Technology for Characterizing Biotherapeutic Protein

Xin Jiang, Product Manager, iCE Marketing, ProteinSimple

Capillary electrophoresis (CE) is a standard method for analyzing complex biotherapeutic proteins. Maurice® system innovates the traditional CE technology by combining both cIEF and CE-SDS detection schemes into one fully automated instrument, enabling easy protein profiling by size or charge. This presentation discusses the application of Maurice for biotherapeutic characterization.

12:45 Session Break

12:55 Luncheon Presentation: N-Glycan Sample Preparation and Analysis Workflows for Screening and Characterization of Biotherapeutics

Aled Jones, PhD, Senior Product & Applications Manager, Marketing, ProZyme

The structure of N-glycans on biotherapeutics can potentially affect immunogenicity, pharmacokinetics and pharmacodynamics, making the characterization of N-glycans an essential part of the development process. We present N-glycan sample preparation and analysis workflows for biotherapeutics, including labeling of released glycans for characterization by liquid chromatography and mass spectrometry, and Gly-Q for rapid screening using an integrated system with capillary electrophoresis.

1:25 Luncheon Presentation II (Sponsorship Opportunity Available)


2:00 Chairperson’s Remarks

Alexey Rak, PhD, Head of Bio-Structure and Biophysics, Integrated Drug Discovery, Sanofi R&D

2:05 Deamidation and Isomerization Liability Analysis of 131 Clinical Stage Antibodies

R. Paul Nobrega, PhD, Scientist, Protein Analytics, Adimab, LLC

The deamidation and isomerization liabilities of 131 mAbs were evaluated under high and low pH accelerated stress conditions. Tryptic peptide mapping was used to identify the modified residues and quantitate the modifications. Comparison across all of the mAbs in our dataset reveals that specific positions within the CDRs have elevated frequencies of modifications under our stress conditions.

2:35 Novel Concert of Biophysical Methods for Multi-Specific Biologics Characterization

Alexey Rak, PhD, Head of Bio-Structure and Biophysics, Integrated Drug Discovery, Sanofi R&D

Modern drug discovery requires characterization of biomolecular interactions to be time- and cost-effective, highly precise and reproducible. New multispecific biologics formats require new approaches to assess their developability. Here we report applications of novel biophysical methods Second Harmonics Generation, nano-Differential Scanning Fluorimetry, MicroScale Thermophoresis and thermal stability kinetics experiments that we are applying in our biologics discovery for multi-specific drugs as well as for mAbs and ADCs. The effectiveness of the novel integrated biophysical methods will be presented and discussed.

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.


4:30 Bioanalytical Challenges for Ocular Therapeutics

Kelly Loyet, PhD, Senior Scientist, Biochemical and Cellular Pharmacology, Genentech

There is a need for long-acting delivery (LAD) modalities for back of the eye ocular biologics to reduce the injection burden and achieve better outcomes. Many proposed LAD modalities that rely on half-life extension pose challenges for bioanalysis due to molecular complexity, immunogenicity, and in vitro to in vivo translation. Here we present new strategies for overcoming bioanalytical challenges in order to better understand and evaluate potential LAD modalities.

5:00 Particle Size Characterization of a mRNA-Containing Lipid Nanoparticle Formulations

Jessica Banks, PhD, Scientist, Moderna Therapeutics

Understanding and controlling the size distribution of therapeutic lipid nanoparticles is essential to the development of a well-defined and stable drug product. Both sub-micron and micron-sized subvisible particles are relevant, highlighting the need for selective and orthogonal techniques applicable to a broad particle size range. This presentation will describe studies on a panel of biophysical techniques to characterize particle size attributes of an mRNA lipid nanoparticle drug product.

5:30 Early Stage Evaluation of Excipient Effects on the Stability of ADCs

Brittney J. Mills, PhD, Senior Scientist II, Drug Product Development, AbbVie, Inc.

Traditional excipients used in standard biologic formulations may affect ADCs differently due to the unique nature of the molecule. The distinct properties of the toxins used in the preparation of novel ADCs require extensive excipient screening to determine the formulation most suitable for the entire molecule. Performing this type of screening is difficult due to the limited material available at this stage in the development process. This presentation will focus on our miniaturized approach for evaluating the effects of excipients on the stability of ADCs.

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

7:15 Close of Day



8:00 am Registration and Morning Coffee


8:30 Chairperson’s Remarks

Jichao (Jay) Kang, PhD, RAC, Director, Analytical Development, Amicus

8:35 Setting Specification for Biologics

Jichao (Jay) Kang, PhD, RAC, Director, Analytical Development, Amicus

Setting appropriate specification is a key control strategy for consistently manufacturing quality biologics product. However, due to the complexity and heterogeneity nature of the biologic molecules, it is challenging to set appropriate specification that can effectively control process variation. The presentation will review the key considerations in setting specification for biologics product in different stages of product development life cycles with case studies presented.

9:05 Automated Carbohydrate Sequencing of Recombinant Protein Therapeutics

Andras Guttman, PhD, DSc, Professor, Horvath Csaba Laboratory for Bioseparation Sciences, Research Centre for Molecular Medicine, University of Debrecen

In this talk, we describe an automated carbohydrate sequencing approach using the appropriate exoglycosidase enzymes in conjunction with the utilization of some of the features of a capillary electrophoresis (CE) instrument to speed up the process. The enzymatic reactions were accomplished within the temperature-controlled sample storage compartment of a capillary electrophoresis unit and the separation capillary was also utilized for accurate delivery of the exoglycosidase enzymes. CE analysis was conducted after each digestion step obtaining in this way the sequence information of N-glycans in 60 and 128 minutes using the semi- and the fully-automated methods respectively.

9:35 Sponsored Presentation (Opportunity Available)

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

11:00 Understanding the Charge Requirements for Hyaluronic Acid Binding for Drug Delivery

Shrenik Mehta, Postdoctoral Fellow, Genentech

In this work a Microscale Thermophoresis (MST) based hyaluronic acid (HA) binding assay was developed that enabled the measurement of peptide - HA binding interactions. This assay was used to interrogate the charge requirements for HA binding. This work provides clues towards engineering peptides for drug delivery with different affinities for HA.

11:30 A Robust and Sensitive Workflow to Assess the ex vivo Stability of Antibody Variants Using CE-LIF

Cong Wu, PhD, Scientist, Biochemical and Cellular Pharmacology, Genentech

We report a highly sensitive and robust workflow to quantify the degraded products of multivalent antibodies using capillary electrophoresis-laser induced fluorescence (CE-LIF) after affinity capture of stressed samples and fluorescent labeling. The improved sensitivity and the simplified quantitative workflow of CE-LIF provide complementary information to LC-MS intact analysis and enables a faster and more reliable data turnaround to trigger in-depth investigation and to gate or rank drug candidates.

12:00 pm Improving Biotherapeutic PK Assays Using Highly Specific Anti-Idiotypic Affimers

Matt Johnson, PhD, CTO, Avacta Life Sciences

The Affimer® scaffold is a versatile next-generation non-antibody platform that offers great potential for both novel biotherapeutics as well as research and diagnostics tools. We have successfully developed anti-idiotypic binders to a range of therapeutic antibody targets to facilitate and improve assays to better facilitate the drug development pipeline. This approach uses only a single target-specific reagent allowing for simpler, more robust and standardizable assay design.

12:30 Session Break

12:40 Luncheon Presentation: Better Protein Characterization Using Tycho to Reveal Protein Quality

Peter Fung, Senior Manager, Product Marketing,  NanoTemper Technologies Inc.

Starting with samples of questionable quality only leads to irreproducible results. Yet, researchers continue to use unvalidated material assuming it’s fine or because they lack an easy test of sample quality. For the first time ever, quickly and precisely determine protein quality in just 3 minutes by using TychoTM NT.6. Tycho fits into any step of a purification or characterization workflow to easily monitor protein quality and enabling researchers to get more consistent results.

1:10 Close of Characterization of Biotherapeutics Conference

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

SC3: Protein Aggregation: Mechanism, Characterization and Consequences

Click here for more details.

*Separate registration required


* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。

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