Immunogenicity and Bioassay Summit

Optimizing Bioassays for Biologics

Bioassays are a critical component of biologics drug discovery and development. With increasingly complex biologic modalities coming to market, including those with multiple mechanisms, accurate biological measurements are crucial. Cambridge Healthtech Institute’s Third Annual Optimizing Bioassays for Biologics will showcase strategies for biologics with multiple modes of action while bridging multiple perspectives on bioassay development. At this event, industry leaders will showcase strategies for assay selection, validation, transfer, and maintenance, with an emphasis on molecules with complex 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.

Who should attend: Optimizing Bioassays for Biologics will bring together key individuals from bioanalytical R&D, cell and antibody engineering, immunology, pharmacology, and preclinical and clinical development.


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WEDNESDAY, NOVEMBER 18


ADVANCES IN BIOASSAY TECHNOLOGIES

2:00 pm Chairperson’s Opening Remarks

 Max L. Tejada, Ph.D., Senior Research Scientist II, Analytical Operations, Gilead Sciences 

 

2:05 Back to the Future, Envisioning the Next Generation Bioassay Development

Ray ZhangRay Zhang, Ph.D., Research Investigator, Bristol-Meyers Squibb

Bioassay development requires a unique combination of techniques, from cell line selection and generation, to assay design, validation and final testing. An ideal bioassay needs to reflect true MOA, robust, sensitive and reproducible. Our thoughts on a bioassay development incorporating advance technologies from in house and vendors will be presented. Our ultimate goal is to develop a system that will have broad and long lasting applications.

2:35 Development of Luminex as a Platform for the Detection of Anti-Drug Antibody IgE Isotypes in Human Serum

LiNa LooLiNa Loo, Ph.D., Senior Scientist, Bioanalytical Development, Merck

Since biotherapeutic drugs such as monoclonal antibodies (mAbs) have the potential to induce immunogenicity, it is critical to perform an immunogenicity assessment to ensure drug efficacy and patient safety. Here, Luminex and Mesoscale were evaluated as platforms for detection of anti-drug antibody IgE isotype in human serum. By using a mouse-human chimeric drug-specific monoclonal IgE antibody as the positive control, the assay characteristics were compared for the two platforms.

3:05 Reporter Assays to Assess Effector Function

Shihua LinShihua Lin, Ph.D., Analytical Biotechnology Development, MedImmune LLC

 

3:35 Sponsored Presentation (Opportunity Available)

3:50 Refreshment Break with Exhibit and Poster Viewing


POTENCY TESTING FOR GENE AND CELL THERAPIES

4:30 Challenges in Potency Assay Development for a Non-Replicating Lentiviral Vector

Brenna Kelley-ClarkBrenna Kelley-Clarke, Ph.D., Scientist II, Assay Development, Immune Design

Immune Design has developed an HIV-1-based integration-deficient lentiviral vector currently being evaluated in cancer immunotherapy (LV305). LV305 is designed to transduce human dendritic cells, triggering presentation of an encoded antigen via the MHC Class I pathway; this is proposed to elicit an effective CD8-T lymphocyte response towards malignancies that over-express that antigen. The biological complexity of LV305 and its proposed MOA pose unique challenges in developing a potency assay matrix.


KEYNOTE PRESENTATION:
5:00 A Regulatory Perspective for Development of Potency Assay for Cellular and Gene Therapy Products: A Product Lifecycle Approach

Xiaobin LuXiaobin (Victor) Lu, Ph.D., CMC Reviewer, Division of Cellular & Gene Therapies, OCTGT, CBER, FDA

The challenges of developing a potency assay for a CGT are multi-factorial including complexity of assay procedures, inherent variability due to use of living cells, tissues or live organisms, and variable reagents. Furthermore, a bioassay based potency assay can be impacted by changes made in the product manufacturing processes. This presentation will outline a product life-cycle approach for developing potency assays for a CGT product from preclinical studies to the Biological License Application. It will conclude with general recommendations for addressing some of the challenges in potency assay development and implementation for CGT during product and clinical development programs.


ASSAY ACCEPTANCE CRITERIA

5:30 Assay Acceptance Criteria for Multiwell-Plate–Based Biological Potency Assays

Jane Robinson C. Jane Robinson, Scientific Liaison, Biopharmaceutical Emerging Best Practices Association (BEBPA)

Following preliminary consultation, a draft white paper “Assay Acceptance Criteria for Multiwell-Plate–Based Biological Potency Assays” was published in 2014. In the subsequent extensive consultation process, a variety of issues were raised and discussed, including a range of current practices. Some of these issues and the recommendations of the white paper, including the two-level sequential assessment of acceptance criteria and use of an assay control sample, will be presented.

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

6:00 Dinner Short Course Registration*

 

6:30-9:30 SHORT COURSE: Strategic Bioassay Development and Design 

Instructor: Liming Shi, MS, MA, Senior Research Scientist, Bioassay Development, Eli Lilly and Company

*Separate registration required.



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THURSDAY, NOVEMBER 19


DEVELOPING ASSAYS FOR MULTIPLE
MODES OF ACTION

7:30 am Registration and Morning Coffee

8:00 am Chairperson’s Remarks

Liming Shi, MS, MA, Senior Research Scientist, Bioassay Development, Eli Lilly and Company

8:05 Bioassay Development for Bispecific Antibodies: A Different Ball Game

Piyush VyasPiyush M. Vyas, Ph.D., Research Scientist, Bioassay Development, Eli Lilly and Company

Bispecific Antibodies are evolving rapidly and are already in stages for clinical trials. Some of these Bispecific Antibodies have shown synergy in their biological activity as compared to the combination of their individual counterparts. Bioassay development and Data analyses for such Bispecific Antibodies to show the synergy, is a complex process. Traditional data analyses approaches might not be suitable enough in order to analyze such data. Data analyses of such Bispecific Antibodies need to be approached in a different way.

8:35 Regulated ADC Bioanalysis Using Ligand Binding Assays: Challenges and Strategies

Seema KumarSeema Kumar, Ph.D., Principal Scientist, Pfizer, Inc.

The complex multi-component structure in combination with heterogeneous and dynamically evolving behavior presents unique challenges in ADC bioanalysis. The challenges may vary depending on the objective of ADC bioanalysis. The case studies showcasing various bioanalytical strategies that could be employed in developing and validating successful ligand binding assays for ADC characterization will be presented.

9:05 Critical Success Factors for Cell-Based Assay Development and Transfer

John Kamerud, Ph.D., Scientific Director, Eurofins

Method development or transfer must occur before a CRO validates an assay. The development / transfer of complex methods that involve the use of cell lines require specific criteria to be evaluated to ensure the success of the assay. In particular, the growth characteristics of the cell line, culture conditions, cell banking requirements, assay format, readout, reagents and data interpretation should be evaluated and controlled to ensure a robust path to validation.

9:35 Problem Solving Roundtable Discussions

These interactive discussion groups are open to all attendees, speakers, sponsors, & exhibitors. Participants choose a specific breakout discussion group to join. Each group has a moderator to ensure focused discussions around key issues within the topic. This format allows participants to meet potential collaborators, share examples from their work, vet ideas with peers, and be part of a group problem-solving endeavor. The discussions provide an informal exchange of ideas and are not meant to be a corporate or specific product discussion.

Table 5: Incorporating New Technologies into Bioassay Development

Moderator: Ray Zhang, Ph.D., Research Investigator, Bristol-Meyers Squibb

  • Is automation an option for bioassay development?
  • High density plates meet precision and accuracy, what is the criteria now?
  • Platforms matters---reporter assay, affinity binding assay, HTRF assay, BRET assay, or your thoughts?
  • New areas, new requirements---how bioassay meets gene therapy and CAR-T technologies?
  • What other technologies can be brought in as a future bioassay platform?

Table 6: Challenges in Assay Bridging

Moderator: Maura C. Kibbey, Ph.D., Senior Scientific Liaison, Biologics & Biotechnology, United States Pharmacopeia

  • Determining if product-related impurities contribute to potency
  • Demonstrating that the method is stability-indicating
  • Pros and cons of parallel assays during clinical development versus switching post-licensure

Table 7: Method Transfers

Moderator: Max L. Tejada, Ph.D., Senior Research Scientist II, Analytical Operations, Gilead Sciences

  • Approaches to clinical, commercial phases
  • Approaches to internal transfers (development to QC lab) and external transfers (different sites, partners and CMOs)
  • Challenges, lessons learned
 

10:35 Coffee Break with Poster Viewing


PROCESS COMPARABILITY AND CHARACTERIZATION

11:15 Use of a Tiered Approach to Develop Robust Potency Assays in Support of Monoclonal Antibody Product Development

Laura GeaganLaura Geagan, Staff Scientist, Analytical Development, Sanofi Global Biotherapeutics

Cell-based assays are often used for evaluating the potency of biological therapeutics during product development. The development of cell-based methods frequently coincides with the stage of development of the product they support. Early stage assays are often required to provide meaningful data to support process, purification and formulation development at a time when optimization of the method is not complete. As the drug progresses through the development paradigm, the performance of the cell-based potency assay improves as well. In this presentation we describe a tiered approach to develop a robust cell-based potency assay to support pre-clinical product development. The analysis paradigm was updated as the drug progressed into Phase I for consistency with guidance provided in USP chapters 1032-1034. The use of the assay to support process development will be discussed. 

11:45 Late Breaking Presentation

12:15 pm Sponsored Presentations (Opportunities Available)

12:45 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

1:15 Cupcakes and Coffee in the Exhibit Hall with Poster Viewing


BRIDGING STUDIES AND ASSAY TRANSFER

2:00 Chairperson’s Remarks

2:05 Transfer and Validation of a Cell-Based Neutralizing Antibody (NAb) Assay to a CRO

Florence GuilhotFlorence Guilhot, Ph.D., Head, Translational Pharmacology Lab, NovImmune SA

Biotherapeutics can lead to the production of anti-drug antibodies (ADA) in treated subjects which may result in loss of efficacy or elicit adverse events. Standard immunoassays can detect ADA, but cannot differentiate between neutralizing and non-neutralizing ADA. Development of a neutralizing antibody (NAb) assay is a key step to support clinical trials. This presentation will provide an overview of (i) assay characteristics of the functional reporter NAb cell-based assay (ii) challenges for the transfer and validation of a NAb assay to support the clinical trial.

2:35 Leveraging Automated Liquid Handlers, High-Density Plates, and Multi-Dimensional Assay Optimization to Accelerate the Delivery of Neutralizing Antibody Bioassay

John LehrachJohn M. Lehrach, Research Scientist II, Bristol-Meyers Squibb

BMS Core BioAssay Group (CBG) leveraged the cellular assay repertoire, cell inventory, and the detection technology platforms in Leads Discovery and Optimization (LDO) Department to perform automation assisted multi-dimentional optimization for the development of a Nab Bioassay. BMS informatics tools enabled automated data analysis. The technology platform selected was a homogenous cAMP HTRF assay. CBG delivered a 96-well format Nab assay with excellent Nab sensitivity, assay reproducibility, and serum tolerance utilizing assay-ready cryo cells.


KEYNOTE PRESENTATION:
3:05 Compendial Potency Assays and Associated Biological Reference Materials – Challenges in Assay Bridging

Maura KibbeyMaura C. Kibbey, Ph.D., Senior Scientific Liaison, Biologics & Biotechnology, United States Pharmacopeia

USP, regulators, and manufacturers share a common goal of reducing in vivo testing, yet replacing animal assays with suitable in vitro assays may be challenging. This presentation will highlight USP’s current efforts to include modern bioassays in the USPNF as well as bridging expectations for revision sponsors who would like to propose a modern assay for the compendium.


3:35 Global Bioassay Transfers

Camille DyckeCamille Dycke, Ph.D., F. Hoffmann-La Roche Ltd. / Genentech; Associate Director, Method Management and Technologies, Bioassay, Global Biologics QC

To support global product release, the bioassay used in the commercial control system of the product is transferred to multiple QC testing laboratories around the globe. In order to facilitate these global method transfers, the implementation of global processes, a global training plan and a solid method life cycle management program, are key elements to ensure success. A few case studies will be presented, illustrating product globalization.

4:05 Close of Conference



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2015 Brochure Cover  

Podcast 

IMN Podcast iconReducing and Monitoring Bioassay Variability 

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