Cambridge Healthtech Institute’s 7th Annual

Optimizing Bioassays for Biologics
( 用于生物制剂的生物测定最佳化 )




As the bioassay field continues to move forward, new technologies and software are changing the way scientists view experimental design and data analysis. The health authorities and USP have provided guidance for the design and validation of a bioassay; however, they do not discuss solutions to common problems springing from this revolution in technology. At Cambridge Healthtech Institute's Seventh Annual Optimizing Bioassays for Biologics, leaders working in bioanalytical and bioassay development will come together to provide case studies and best practices for handling the most common issues in biological assay development, validation, transfer, and maintenance. There will also be a focus on new modalities including cell therapies (encompassing immunotherapies), gene therapies and antibodies. In addition, new technologies and bioassay formats will be presented along with recommendations for implementation to ensure a steady drug development pipeline.

Final Agenda

Recommended Pre-Conference Workshop*

October 15: Biostatistics for Beginners

* Separate registration is required.

Recommended Pre-Conference Training Seminar*

October 16-17: An Introduction to Strategic Bioassay Design, Development, Analysis, Validation, and Monitoring

* Separate registration is required.


1:00 pm Conference Registration


1:40 Chairperson’s Opening Remarks

Nancy Sajjadi, MSc, Independent Quality Consultant

1:45 Ensuring Biosimilar Monoclonal Antibody Product Consistency through New Publicly Available Bioassay Standards

Sandra Prior, PhD, Senior Scientist, Biotherapeutics, National Institute for Biological Standards and Control (NIBSC)

The increasingly complex product landscape for biotherapeutic monoclonal antibodies and their biosimilars highlights the need for publicly available bioassay International Standards. These preparations are intended for the calibration of bioassays and local standards, allowing harmonization of bioassay data across products and jurisdictions. International Standards for monoclonal antibodies support a knowledge-based approach to addressing future challenges of potential drifts and divergence in the bioactivities over the lifecycle of these products and will contribute to long-term product consistency.

2:15 Making USP Bioassay Chapters Fit the New Assay Paradigm

Steven Walfish, MBA, Principal Scientific Liaison, USP

Laboratory automation, gene therapy assays, and new assay formats are challenging the USP Bioassay Chapter paradigm. During the initial development of the USP Bioassay chapters, the focus was on relative potency assays using a standard. This talk will focus on changes proposed to USP Bioassay Chapters to address the new challenges from our stakeholders to ensure that the Bioassay Chapters stay relevant.

2:45 PANEL DISCUSSION: Emerging Standards for Bioassays

Moderator: Nancy Sajjadi, MSc, Independent Quality Consultant

Panelists: Steven Walfish, MBA, Principal Scientific Liaison, USP

Sandra Prior, PhD, Senior Scientist, Biotherapeutics, National Institute for Biological Standards and Control (NIBSC)

BioAgilytix3:15 Talk Title to be Announced

Kathryn Lindley, Vice President, Operations, BioAgilytix

3:45 Refreshment Break in the Exhibit Hall with Poster Viewing


4:25 Functional Bioassays for Immune Check Point Inhibitor Screening and I/O Selection

Sofie Pattijn, CTO, ImmunXperts

Early evaluation of the effectiveness of candidate therapeutics and combination therapies can be done using in vitro bioassays with primary mouse or human immune cells. Mixed lymphocyte reaction assays using both innate cells and lymphoid cells mimic a physiological T cell response and are widely used for the potency screening of candidate therapeutics. The use of different allogeneic donor combinations can provide additional information on the profile of the responding population. An important factor for sensitive assays and consistent results is the quality of the primary immune cells.

4:55 Harnessing Biolayer Interferometry to Overcome Aggregates Interference in the FcgRIIa Binding Assay

Adriana Bajardi-Taccioli, Scientist II, Analytical Development, Biogen

FcgRIIa receptor binding is a part of the mechanism of action for many therapeutic antibodies. The presence of aggregates can impact the binding of Fc-containing molecules to FcRn and FcR, masking actual changes in Fc activity. This presentation will describe a FcgRIIa binding assay based on Biolayer Interferometry, suitable for testing samples with moderate levels of aggregates, and capable of detecting differences in Fc binding due to various glycosylation patterns.

5:25 Late Breaking Presentation

5:55 Dinner Short Course Registration

6:15 - 9:15 pm Recommended Dinner Short Course*

SC5: Bioassay Quality by Design

Instructor: Thomas Little, PhD, President and CEO, Bioassay Sciences, Thomas A. Little Consulting

The course will present and discuss the critical elements of designing a bioassay. The course will include the following. The course is essential for those individuals designing or validating a bioassay.

Topics covered include:

  • Range Finder Study Design for Dose Selection
  • Number of Doses in the Dose Response
  • Number of Plates and Plate Layout
  • PLA versus 4PL Fitting Methods
  • Outlier ID and Removal
  • Dose Masking for PLA
  • Robust Design and Optimization for a Bioassay
  • Standard Selection and Qualification
  • Validity and Systems Suitability Criteria Selection and Setting Limits

*Separate registration is required.


7:30 am Problem Solving Roundtable Discussions


8:30 Chairperson’s Opening Remarks

Sandra Prior, PhD, Senior Scientist, Biotherapeutics, National Institute for Biological Standards and Control (NIBSC)

8:35 Method Validation Based on Total Error

Harry Yang, PhD, Senior Director, Statistical Sciences, AstraZeneca

9:05 Establishing Validity Criteria for Bioassays

Daniel Harding, Principal Consultant, Bioassay Sciences

Presentation will cover validity and systems suitability alternatives, best practice, and regulatory requirements. It will discuss the rationale and justification for selection of criteria for both 4PL and PLA type bioassays. Statistical and practical risk-based method of setting the limits will be presented with associated recommendations and templates to set limits.

9:35 Sponsored Technology Panel (Only 3 Opportunities Available)

In this panel discussion, vendors creating solutions for bioassay design and analysis will present their technologies. To participate, please reach out to Carolyn Cooke, Business Development Manager at or 781-972-5412

10:05 Coffee Break in the Exhibit Hall with Poster Viewing

10:45 Strategies and Adaptations of Automated Workflows for Cell-based Assays

Jeanette Villarreal-Kinney, Senior Research Associate, Technical Development, Biological Technologies, Genentech, Inc.

11:15 The Analytical Target Profile and Bioassay Development

Ryan Yamagata, US Function Head, CMC Statistical Sciences, Vaccines Technical Research & Development, GSK

ICH Q8(R2) does not explicitly refer to analytical method development. However, a Quality by Design (QbD) approach can also be applied to bioassay development, driven by the Analytical Target Profile (ATP). This talk will present how the ATP can be used as a guide for bioassay development and assess the fitness for use of a bioassay.

11:45 Statistical Approach to Reference Material Bridging

Jia Liu, PhD, Manager, Pharm Science & PGS Statistics, Pfizer Inc.

Reference materials play a significant role in calibrating and trending the performance of some analytical assays, including bioassays. These analytical assays are used to assess the product quality in a number of activities, such as characterization, comparability, lot release, and stability. However, the guidelines for bridging a new reference material to a current one are general and there is not a clear best practice across industry. To assess the suitability of the new reference material, including full characterization of the material, a powered statistical assessment is proposed to ascertain that the new reference material is equivalent to the existing reference material. Statistical approaches based on different phases of product development will be presented and discussed herein.

12:15 pm Sponsored Presentation (Opportunity Available)

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

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


1:55 Chairperson’s Remarks

Chairperson to be Announced

2:00 Recent Results on Equivalence Test Bounds to Limit Non-Similarity Induced Bias in Potency, with Additional Discussion about Power

David Lansky, PhD, President, Precision Bioassay, Inc.

Minimizing bias of potency is a major goal of bioassay design, development, validation, and monitoring. Sensitivity analyses show that non-similarity causes appreciable bias. Similarity equivalence bounds (for scaled shifts) can be set to limit bias in potency due to non-similarity; these results are robust to both the design and properties of assays. Additionally, power analyses for similarity assessment are not routine; we show why they are important.

2:30 PANEL DISCUSSION: Methods for Setting Equivalence Bounds

Moderator to be Announced

Panelists: Ryan Yamagata, US Function Head, CMC Statistical Sciences, Vaccines Technical Research & Development, GSK

Harry Yang, PhD, Senior Director, Statistical Sciences, AstraZeneca

3:30 Close of Optimizing Bioassays for Biologics

* 活动内容有可能不事先告知作更动及调整。

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