Immunogenicity Summit
Immunogenicity and Bioassay Summit
2013 Archived Content

Optimizing Bioassays for Biologics 

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Wednesday, November 13

Managing Variability 

8:30 am Chairperson’s Remarks

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

8:35 Regulatory-Compliant Validation of a Standardized ADCC Potency Assay

Alexis Rossignol SAlexis Rossignol, Ph.D., R&D Project Manager, Clean Cells SAS

Antibody-dependant cellular cytotoxicity (ADCC) is one of the major mechanisms of action of therapeutic monoclonal antibodies (mAbs), with a growing number of "ADCC-optimized" mAbs. Health Agencies require the use of biologically-relevant potency assays to characterize new mAbs and to release batches. But current ADCC assays are hampered by reproducibility and standardization issues, especially when they involve freshly isolated primary human cells (PBMC, NK…) as effector cells. In this context, Clean Cells and its partner INSERM UMR892 have developed an ADCC assay based on standardized CD16-expressing effector T cells. This presentation will show its outstanding performances in terms of accuracy, linearity, repeatability, reproducibility and sensitivity to mAb modifications (fucosylation…). These results were obtained in a validation study designed to meet EMA requirements and support the use of this robust assay for lot release.

9:05 Evaluation of Processes for Reducing and Monitoring Assay Variability for Bioassays  -   Listen to PODCAST 

Janet Lathey SJanet L. Lathey, Ph.D., Director, Immunology and Assay Development, BioDefense Division, Emergent BioSolutions

Within the life cycle of a product several developmental phases of a bioassay usually occur. A major challenge with potency testing is the establishment of consistency of results by reducing and maintaining assay variability. Some essential processes to reduce and evaluate variability are 1) identification of assay components responsible for major assay variation; 2) identification and qualification of critical reagents; 3) bridging of reference sera to a “standard”; and 4) documented analyst training program.

Bioassay Automation Technology 

9:35 Bioluminescent NFAT-RE-luciferase Reporter Bioassay: A Novel Technology to Reduce Assay Variability in ADCC

MN DixitM.N. Dixit, Ph.D., Assistant General Manager & Head, Bioanalytical Laboratory, Clinigene International

Bioassays play a vital role in evaluating biological functions of protein biotherapeutics. Classic Antibody Dependent Cell Mediated Cytotoxicity (ADCC) assays involving Natural Killer cells are utilized for potency evaluation of therapeutic antibodies. However, high variability makes such assays less dependable for evaluating the targeted function of biologic drug products. The new bioluminescent NFAT-RE-luciferase reporter bioassay is ideal for evaluating Fc effector functionality of therapeutic antibodies in ADCC.

10:05 Sponsored Presentation (Opportunity Available)

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

11:15 Assay Development, Automation and De-Convolution of Multiplexed High Throughput Live-Cell Screens

Brad Greenfield SBrad Greenfield, Scientist, Theraclone Sciences

Utilizing a live whole cell approach to Theraclones antibody screening platform, we are able to interrogate entire extra-cellular proteomes in a target-agnostic manner, and multiplex via pooled cell types to increase throughput and identify conserved epitopes/targets across multiple cell types. Assay design, automation, confirmation and de-convolution of multiplexed screening data will be presented.

11:45 From Spleen to Screen

Cecile Geuijen, Ph.D., Senior Director, Oncology, Merus BV

Merus has developed and validated a powerful discovery engine for the discovery of potent and fully human bispecific antibodies targeting cancer: Biclonics™. Direct sequencing of antibody variableregions from the spleen of immunized MeMo® mice and subsequent co-expression of these antigen specific variable regions into bispecific moleculesusing automated multi-well systemsenables the rapid screening of thousands of unique Biclonics™ in in vitro functional assays. Lead candidates areidentified based on potent growth inhibition oftumor cells.

12:15 Problem Solving Roundtable Discussions

Table 1: Standardizing ADCC Potency Assays

Moderator: Alexis Rossignol, Ph.D., R&D Project Manager, Clean Cells SAS

Table 2: Meeting USP Standards for Bioassays

Moderator: Tina S. Morris, Ph.D., Vice President, Biologics & Biotechnology, United States Pharmacopeial Convention, Global Science & Standards Division

Table 3: Assay Automation to Decrease Variability

Moderator: Brad Greenfield, Scientist, Theraclone Sciences

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

Considerations for Biosimilars 

2:00 Chairperson’s Remarks

Cecile Geuijen, Ph.D., Senior Director, Oncology, Merus BV

2:05 Special Considerations for Developing Cell-Based Immunogenicity Neutralizing Anti-Drug Antibody (NAb) Assays to Support Clinical Comparability Studies for Biosimilars

Xiao-Yan Cai SXiao-Yan Cai, Ph.D., Director, Biologics Bioanalytical Development, Merck Research Laboratories

Immunogenicity assays are critical to support comparability studies to ensure safety and efficacy of a biosimilar in comparison with its originator biologic therapeutic drug per regulatory guidance. Demonstrating “equivalency” of the non-quantitative cell-based NAb assay to detect NAbs against both biosimilar and originator compounds presents unique challenges. Special considerations must be taken into account during assay development of these NAb assays.

2:35 Functional Assays for Biosimilars: An Industry Perspective

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

Functional characterization of a biosimilar to its reference product is essential to biosimilar therapeutic 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.

3:05 Refreshment Break

Cell-Based vs. Non-Cell-Based Assays 

3:30 Comparison of Cell-Based and Non-Cell-Based Assay Platforms for the Detection of Anti-Drug Neutralizing Antibodies

Jenny Hu SJenny Hu, ATO Clinical Immunology, Medical Science, Amgen, Inc.

Different assay platforms have been used for the detection of neutralizing antibodies. Evaluations of these platforms were mostly focused on assay development and characterization; limited data were generated using clinical samples. In this study, non cell-based assays were developed and assessed for their ability to detect neutralizing antibodies as compared to its complementary cell-based assays. Case studies comprised of several therapeutic molecules and comparison of results from clinical samples will be discussed.

4:00 Non-Cell-Based Assay and Cell Based Assays In Support Of Antibody Development Programs

Jeffrey BarbonJeffrey Barbon, Senior Scientist, Renal and Immunology Biologics (RIB), abbvie

Lead candidate antibody generation requires a battery of in vitro assays for characterization studies including functionality. Non-cell-based assays are typically an easy first step in the antibody screening process but the true quality of antibody leads must inevitably be established in cell-based functional assays. Several case studies will be highlighted.

4:30 Close of Optimizing Bioassays for Biologics 

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