2013 Archived Content
Bioassays for Biologics 


Day 1 | Day 2
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Tuesday, March 20, 5:00 – 6:00 PM


Bioassays play a vital role in the characterization, comparability, stability and potency testing of large molecule therapeutics. The inaugural Biossays for Biologics will bring together key individuals from across CMC, Bioanalytical Sciences, and Bioprocessing to share strategies and methods for developing and validating bioassays to advance the development of biotherapeutics.

Pre-Conference Welcome Reception in the Exhibit Hall with Poster Viewing


Wednesday, March 21

8:00 am Registration and Morning Coffee

8:30 Chairperson’s Opening Remarks

Max TajedaMax L. Tejada, Ph.D., Senior Scientist, Biological Technologies, Genentech, Inc.Biography 



Featured Presentation 

8:35 Bioassays Empower Biologics Development

Patrick LiuPatrick Liu, M.D., Ph.D., Senior Director and Global Head of Bioassays, Teva Pharmaceuticals, Inc. - Biography 

Bioassays or biological assays play critical roles in many aspects, including product potency determination, biological characterization, comparability, stability, and as well as bioanalytics in support of pre-clinical and clinical studies throughout the span of biologics development. With an appropriate assay strategy and clear understanding of regulatory expectations, development and implementation of validated biological assays can generate a successful regulatory submission package, and therefore, significantly contribute to the quality and success of the program, and as well as save the overall development time and cost.

9:05 International Bioassay Standardization

Michael ToveyMichael Tovey, Ph.D., Director of Research, Biotechnology & Applied Pharmacology at ENS Cachan - Biography 

A common validated assay for biologics sharing the same target allows direct comparisons of the relative potency and immunogenicity of innovator molecules and biosimilars. The common assay methodology for neutralizing antibodies against different interferon beta products established by the EMA and current initiatives to develop a common cell-based assay for the quantification of the potency and relative immunogenicity of different TNF-alpha antagonists will be outlined.

9:35 Functional Bioassays as Tools for Biosimilar Development

Cornelius Fritsch, Ph.D., Fellow, Technical R&D Biologics, Analytical R&D, Novartis Pharma AG - Biography 

The demonstration of similarity to the reference medicinal product is key to the successful development of Biosimilars. One key focus area for the demonstration of similarity is the quantitative assessment of various aspects of a molecule’s activity. Recently published draft guidance from the EMA indicates a strong interest of the authority in comprehensive functional characterization of a Biosimilar in comparison to its reference product. A case study outlining the functional characterization of a biosimilar monoclonal antibody currently in development will be presented.

10:05 Sponsored Presentation (Opportunity available, please contact Jon Stroup, jstroup@healthtech.com)

10:25 Networking Coffee Break in the Exhibit Hall with Poster Viewing


Featured Presentation 

11:00 Cell Based Therapeutics:  The Challenges of Developing Relevant Potency Assays

Alice GrebanierAlice Grebanier, Ph.D., Director, Bioassay Method Development, Janssen Research & Development - Biography 

The FDA guideline cell therapy products outlines general approaches to developing a suitable strategy for testing potency.  The requirements for methods that are relevant to the biological activity of the cellular product are clearly related to current expectations for potency assays for biologic products.  This presentation will discuss application of concepts of relevance to development of potency methods for cellular therapies, as well as the potential use of a matrix of methods to measure potency.

11:30 Bioassay Development and Validation: Challenges to Identify “Platform” Approaches for Unique and Complex Bioassays

Karen Blank, Senior Scientist, Analytical Research & Development, Pfizer

Many factors should be considered when selecting the appropriate method for assessing biological activity.  Balancing the need for quick, precise and robust assays with proper scientific rationale for a particular method (MOA and type of molecule) is part of the challenge and often requires a shift in the approach over the life of a project.  This talk will focus on issues and possible solutions for synchronizing the bioassay approach with dynamic project knowledge and development timelines.   Finally, we ask the question, “How do we bridge the gap when changes are necessary?”

12:00 pm The Road from Potency to Neutralizing Antibody Assays: Twists, Turns and Bumps

Renuka C. Pillutla, Ph.D., Associate Director, Bioanalytical Sciences, Bristol-Myers Squibb - Biography 

Cell-based neutralizing antibody (NAb) assays are designed to detect antibodies in patient matrix that neutralize the function of the drug. A cell-based potency assay is generally a good starting point for NAb assays. However, development of NAb assays presents a different set of challenges due to the effect of matrix components and the need for acceptable sensitivity to neutralizing antibodies. This presentation will highlight some of the challenges faced as we go from potency assays to NAb assays.

12:30 Luncheon Presentation (Opportunity available, please contact Jon Stroup, jstroup@healthtech.com) or Lunch on Your Own

2:00 Chairperson’s Remarks

C Jane RobinsonC. Jane Robinson, Ph.D., Principal Scientist, Biotherapeutics, National Institute for Biological Standards and Control, UK - Biography


2:05 Bioassay Development – Challenges along the Way from Research Method to Quality Control Test

Jeffrey Glenn, Ph.D., Associate Director, Large Molecule Method Development, Pharmaceutical Development & Manufacturing Sciences, Janssen Research & Development, LLC - Biography 

Bioactivity assays (which include both cell-based assays and immunoassays) are an essential part of large molecule therapeutic drug characterization and stability/release testing. Bioassay development organizations may be required to deal with all of the following activities when an NME is introduced to development: assay transfer from Discovery to Development, assay optimization, validation, transfer to QC, and continuing support. Unique issues and challenges are encountered at each step. This presentation will provide examples.

2:35 Complementary Role of Bioassays and Analytical Assays to Characterize Antibody-Maytansinoid Conjugates

Sonia Connaughton, Ph.D., Bioassay Development Group Leader, Translational Research, ImmunoGen, Inc. - Biography 

Antibody-Maytansinoid Conjugates (AMCs) are anticancer agents comprising a tumor-targeting antibody with a maytansinoid cytotoxic agent attached.  AMCs are designed to deliver the cytotoxic agent selectively to the tumor tissue by targeting an antigen expressed on the surface of a cancer cell.  This talk will focus on the relationship between bioassays and analytical methods.  In addition, it will discuss the special considerations that need to be taken with respect to Bioassays when the product is conjugateas compared to a naked antibody.


3:05 Use of Reference Standards in Bioassays

C Jane RobinsonC. Jane Robinson, Ph.D., Principal Scientist, Biotherapeutics, National Institute for Biological Standards and Control, UK - Biography 

Bioassays are comparative, measuring relative potency. Development of an in-house reference standard is required early in product development. Issues that must be considered in development and use of reference standards include demonstration of functional similarity of reference standard and test material, stability of the reference standard, continuity on replacement of a reference standard, and potential problems on changing the bioassay system.


3:35 Networking Refreshment Break in the Exhibit Hall with Poster Viewing

4:00 Understanding Differences in Approaches in Bioassay Analysis

Timothy SchofieldTimothy Schofield, Managing Director, Arlenda, Inc.; former Director, US Regulatory Affairs, GlaxoSmithKline - Biography 

With the forthcoming publication of the USP chapters on bioassay development, validation, and analysis, practitioners will be challenged with a different approach for assessing their bioassay data. A conventional method of testing for differences in slopes between test and standard samples has been replaced by an equivalence approach, which seeks to demonstrate that slopes are adequately similar. In addition to the change inmethodology, this requires a definition of “adequately similar.” This talk will compare the difference and equivalence approaches, and will examine ways to establish a similarity margin for a bioassay.

Featured Presentation 

4:30 Reference Standard for Assessment of Therapeutic Monoclonal Antibody Products Potency - A Regulator’s Perspective

Carla LankfordCarla R. Lankford, M.D., Ph.D., Quality Reviewer, Monoclonal Antibodies, OBP / OPS / CDER - Biography 

5:00 Breakout Discussions 

Table 1: Regulatory & Bioassays

Moderator: Brian Harvey, M.D., Ph.D., Vice President, Regulatory Policy, Sanofi-Aventis

  • How does the FDA regulation of bioassays differ depending upon if it is a stand alone device vs. part of a drugs-device, or biologic-device combination?
  • What is the difference between assay qualification and assay validation from the FDA perspective?
  • What is the current Biomarker qualification process at FDA?

Table 2: Reference Standards for Bioassays

Moderator: C. Jane Robinson, Ph.D., Principal Scientist, Biotherapeutics, National Institute for Biological Standards and Control, UK - Biography 

  • At what stage do you make your first in-house standard? How do you formulate/process/store/monitor your standard? How do you replace your in-house standard?
  • What factors might affect the suitability of an external standard for your product/assay?  What might be the implications for you on replacement of an external standard and what actions can you take?
  • What about the discussion on changing calibration of some proteins to SI units? How would SI or other form of mass unitage be applied to bioassay standards, especially for heterogeneous protein mixtures?

Table 3: Transfer to QC

Moderator: Jeffrey Glenn, Ph.D., Associate Director, Large Molecule Method Development, Pharmaceutical Development & Manufacturing Sciences, Janssen Research & Development, LLC - Biography 

  • Is it possible to transfer assays without face-to-face training of analysts?
  • Is analyst training best performed at the developing lab or the receiving lab?
  • How successful are gap analyses as replacement for formal transfers?
  • Should evaluation of transfer success be based on statistical comparability between labs or on achieving results within fixed limits?
  • Is periodic review of raw data from QC lab needed to ensure continued assay consistency?

Table 4: Assays for Comparability Studies

Moderator: Max L. Tejada, Ph.D., Senior Scientist, Biological Technologies, Genentech, Inc. - Biography 

Table 5: Bioassays for the Development of Biosimilars

Moderator: Philip A. Krasney, Ph.D., Senior Scientist II, Bioassays, Teva Pharmaceuticals, Inc. - Biography 

6:00 End of Day One of Bioassays for Biologics

Day 1 | Day 2
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