Immunogenicity Summit

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In biologics drug development, a reliable bioassay is crucial to the approval of the final product. However, when developing new drugs, a lack of data on the relevant mechanism-of-action can slow progress. This can become especially complex with new biologic modalities such as bispecifics and antibody drug conjugates. At Cambridge Healthtech Institute’s Second Annual Optimizing Bioassays for Biologics conference, industry leaders will showcase strategies for assay selection, validation, transfer, and maintenance with an emphasis on molecules with multiple mechanisms. Health authorities will weigh in on new guidelines as well as provide insight into what they consider a well-characterized biologic. Finally, new technologies and bioassay formats will be presented along with recommendations for implementation to ensure a steady drug development pipeline.


1:00 pm Conference Registration

2:00 Chairperson’s Opening Remarks

David Lansky, Ph.D., President, Statistics, Precision Bioassay, Inc.


2:05 Development of MOA Reflective Cell-Based Potency Assays for Biologic Products Involved in T Cell Co-Signaling Pathways

ShihuaLinShihua Lin, Ph.D., Analytical Biotechnology Development, MedImmune LLC

Potency assays play a key role at all stages of product lifecycle from early development to finished products. Due to increasing diversity and complexity of product formats as well as clinical targets, developing and optimizing MOA (mechanism of action) reflective cell-based potency assay could be challenge. This presentation will highlight general considerations and our approaches used to develop validatable cell-based potency assays for biologic products involving in T-cell co-signaling pathways.

2:35 Selecting the Best Bioassay Format to Assess mAb Stability

NatkoNuberNatko Nuber, Ph.D., Biologics R&D, Novartis

An ideal bioassay should mimic the MoA and be able to detect changes in the integrity of the drug. A case study of two related mAbs, specific for the same epitope of a membrane target, is presented. Temperature stressed and post-translationally modified samples were tested in four different bioassays; the different bioassays generated divergent results, suggesting that caution is needed when selecting the most appropriate bioassay format for membrane-bound targets.

3:05 Improving Heparin Bioassays by Following USP <1032>

DavidLanskyDavid Lansky, Ph.D., President, Statistics, Precision Bioassay, Inc.

The recently revised USP monograph on the Heparin bioassay includes specific design recommendations, several options for replication strategies, and offers users the choice of slope ratio or parallel line analyses. The recommended design imposes a split-unit design (USP <1032>). Recognizing that the assay design is a split-unit leads to useful insights about ways to improve the assay design and analysis. The split-unit design used has very low power for similarity testing in a slope ratio analysis, but good power for similarity testing in a parallel line analysis. Hence, for the Heparin bioassay (and related assays), the slope ratio analysis is a poor choice. The impact of these choices will be illustrated with data.

3:35 Non-Wash Immunoassays and Label-Free Assay Platforms for Development of Immunogenicity Assays for Known Biosimilars 

Lindsay Nelson, Ph.D., Field Application Scientist, PerkinElmer

We will show how Alpha Technology and label-free technology can be used as an alternative to ELISA or electro-chemiluminescence in immunogenicity and anti-drug-antibody assays. We will combine the use of antibodies to known biosimilars with PerkinElmer’s assay technologies to demonstrate several ways to improve your current methods for measuring immunogenicity.

3:50 Refreshment Break in the Exhibit Hall with Poster Viewing


4:30 Bioassays for Antibody Maytansinoid Conjugates (AMCs) Having Multiple Activities

GillianPayneGillian Payne, Senior Director, Bioanalytical Science, ImmunoGen, Inc.

All AMCs have potent maytansinoid-directed anti-tumor activity. Some AMCs also have additional antibody-directed anti-tumor activity. A control strategy for such AMCs will be presented.


5:00 Development of a Simultaneous Binding Assay to Determine Potency of a Bispecific Zybody

Palanisamy Kanakaraj, Ph.D., Senior Project Manager & Principal Investigator, Smithers Avanza

Zybodies are mutli-specific antibodies generated by fusion of specific peptides to scaffold antibodies. We have developed a simultaneous binding assay to determine potency of a bi-specific zybody. The ability of the assay to measure the changes in potency of bi-specific zybody against each target molecule was determined. Comparability studies with ligand binding and cell based functional assays will be discussed.


5:30 Characterization of Response of Multiple Domain Biotherapeutics

Jaya GoyalJaya Goyal, Ph.D., Director, Translational Sciences, Biogen Idec

Many biotherapeutics currently in development have complex mechanisms of action and contain more than one domain, each with a specific role or function. As it is beneficial to align industry standards for evaluating immunogenicity of MDBs, this presentation highlights pertinent immunogenicity risk factors and describes steps involved in the design of a testing strategy to detect and characterize binding (non-neutralizing and neutralizing, NAb) ADAs.

6:00 End of Day One of Optimizing Bioassays for Biologics

6:00 Dinner Short Course Registration

6:30 – 9:30 Dinner Short Courses*

SC3: Immunogenicity Risk Assessment and Regulatory Strategy

SC4: Strategic Bioassay Design and Analysis 

*Separate Registration Required.



8:00 am Chairperson’s Remarks

8:05 Presentation to be Announced

8:35 Comparability Studies for Bioassays: Technical and Regulatory Challenges for Commercial Products

Jan BohuslavJan Bohuslav, Ph.D., Scientist, Global Biologics Quality Control, Method Management and Technology (MMTech), Genentech, Inc., A Member of the Roche Group

For commercial products, both technical and regulatory requirements need to be considered when replacing or updating the licensed potency methods. A well-designed comparability assessment with meaningful acceptance criteria, which is dependent on the capability of the method, and should be evaluated case by case, is key to technical success and regulatory acceptance.  

Eurofins Bioanalytical Services9:05 Case Study: Product Characterization, PK and Immunogenicity Assays for the Development of Biosimilar Trastuzumab 

John_EurofinsJohn Kamerud, Ph.D., Scientific Director, Eurofins Pharma Bioanalytical Services

In assessing the comparability of proposed biosimilar compounds to the innovator counterparts, regulatory agencies have stressed the “totality-of-evidence” approach, which relies on both structural and functional characterization, as well as data from animal and clinical studies. We present as a case study a package of assay methods developed for one such biosimalar, trastuzumab, which will include characterization of target binding, Fc receptor binding and ADCC activity as well as PK and immunogenicity assays to be used in clinical studies. Challenges encountered and approaches taken in the development of these methodologies will be discussed.

9:35 Problem Solving Roundtable Discussions

Strategies for Bioassays with Multiple Mechanisms

Moderator: Gillian Payne, Senior Director, Bioanalytical Science, ImmunoGen, Inc.

  • Aligning industry standards for MDB evaluation
  • Control strategies for molecules with multiple activities
  • Which bioassays are most effective?

Selecting the Right Bioassay

Moderator: Natko Nuber, Ph.D., Biologics R&D, Novartis

  • Finding the right balance between closeness to MoA and assay validability. Ways to reduce (improve) the assay variability e.g. replication strategies
  • Monitoring assay performance: EC50, SSTs, product control
  • Ways to monitor reference standard? Introduction of Primary standard vs working standard?

Maintaining Assay Consistency

 Moderator: Janet Lathey, Ph.D., Consultant, Product and Assay Development and Evaluation

  • What is the importance of assay consistency in product development and evaluation?
  • What steps can be taken to promote consistent assay performance?
  • How do you confirm that an assay is performing consistently over time or across laboratories?

10:35 Coffee Break in the Exhibit Hall with Poster Viewing


11:15 Preventing False Data Reporting: A Cell-Based Neutralizing Antibody Assay Case Study

LaKenyaWilliamsLaKenya Williams, Ph.D., Senior Research Investigator I, Bioanalytical Sciences - Biologics, Bristol-Myers Squibb

Cell-based neutralizing antibody assays are inherently variable. Inadequate assay controls, including baseline samples and performance monitoring, can make cell-based assays particularly vulnerable to false data reporting. The FDA recognizes the difficulty in determining the degree of inhibition that is accurately indicative of neutralizing antibodies in a clinical sample. The recommendation is that the determination should be statistically based and derived using naive patient samples. This presentation will discuss various statistical approaches utilized for establishing Nab assay cut point and how we have managed inter-patient variability to ensure high data integrity during clinical trials.

11:45 Evaluation of Assay Consistency Over the Life Cycle of a Product

JanetLatheyJanet Lathey, Ph.D., Consultant, Product and Assay Development and Evaluation

During product development and evaluation, critical assays undergo modifications. Assay results from preliminary studies often need to be bridged to those of pivotal studies. A testing and statistical approach to evaluate the consistency of assay results before and after assay modifications will be presented.

12:15 pm Sponsored Presentations (Opportunities Available)

12:45 Networking Lunch in the Exhibit Hall with Poster Viewing (Sponsorship Opportunity Available)


1:45 Chairperson’s Remarks

Janet Lathey, Ph.D., Consultant, Product and Assay Development and Evaluation

1:50 SPARCL™ : A Novel Homogeneous Chemiluminescence Immunoassay Technology for Ligand Binding Assays

Speaker to be Announced, Lumigen, A Beckman Coulter Company

Biomolecular binding interactions are commonly monitored using antibodies and other proteins with detectable labels in formats such as ELISA, electrochemiluminescence, fluorescence and proximity assays. SPARCL™ is a no-wash, cost effective and flexible proximity assay capable of detecting common protein targets, as well as targets that are difficult to measure using other homogeneous assay technologies. SPARCL™ technology allows for simple reagent preparation and rapid assay optimization without dependence on particles or a solid surface. <br /><br />Examples of antibody-antigen assays are shown in a variety of formats demonstrating both flexibility of the SPARCL™ system and assay performance. This will include application of SPARCL™ technology for biomarker, pharmacokinetic (PK), immunogenicity, the measurement of analytes in cell based experiments, as well as use in a high throughput environment.<br /><br />SPARCL™ technology enables rapid immunoassay development, desirable performance characteristics and allows for considerable savings in labor, disposables and capital equipment compared to other immunoassay platforms. Existing software and luminometers can be used for a SPARCL™ data acquisition, and as a result, there may not be a need to validate new software in existing Laboratory Information Management Systems (LIMS). The SPARCL™ assay is microtiter plate-based and is suitable for use with robotics and in higher throughput applications.

2:20 High-Throughput Antibody Selection and Screening Methods for Improved Downstream Developability

WilliamRoachWilliam Roach, Ph.D., Scientist, Antibody Engineering and Platform Transfer Manager, Adimab, LLC

Antibody developability issues, such as aggregation and low solubility, can be reduced by employing specificity reagents during antibody discovery. These discovery approaches as well as high throughput methods for tracking antibody self or cross-interaction will be discussed.

2:50 Networking Refreshment Break


The Science and Regulation of Potency Assays for Assessing the Quality of Biopharmaceuticals

Baolin ZhangBaolin Zhang, Ph.D., Senior Investigator, Therapeutic Proteins, Biotechnology Products, FDA

Assay adequacy is assessed by taking account of multiple factors including, but not limited to, product type, history, mechanism(s) of action (MoA), associated risk, phases of development, and quality data from physicochemical and biochemical testing. This presentation provides an overview of regulatory expectations regarding potency assays and discusses several case studies that highlight some of the relevant issues commonly seen in the regulatory submissions.

3:45 Compendial Potency Assays and Associated Biological Reference Materials – Challenges in Assay Transition and Unit Maintenance

Maura C. Kibbey, Ph.D., Senior Scientific Liaison, Biologics & Biotechnology, U.S. Pharmacopeia

With increasing frequency, especially for legacy biologics, animal assays are being replaced by in vitro assays of different formats. This transition is not always straightforward, as analysts may struggle to establish equivalence between assays that measure different attributes or sets of attributes. This presentation will focus on USP’s current efforts to include modern in vitro assays in the USP-NF to replace animal-based tests for well-characterized biologics.

4:15 End of Optimizing Bioassays for Biologics

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2014 Brochure Cover

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 Charles River(1) 


IMN Podcast iconReducing and Monitoring Bioassay Variability 

2013 Speaker: Janet L. Lathey, Ph.D., Director, Immunology and Assay Development, BioDefenseDivision, Emergent BioSolutions