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The discovery and development of emerging therapies such as bispecifics, antibody-drug conjugates, biosimilars, and cell/gene therapies has raised the bar for bioassay scientists. The Third Annual Optimizing Bioassays for Biologics discusses the latest day-to-day challenges in bioassay design, development and validation for traditional and emerging biologics with case studies and shared insight from key industry players on new assay technologies, formats and platforms; strategies for increasingly complex biologic modalities; assays with improved sensitivity, specificity and selectivity; tech transfer, outsourcing and the application of statistics in bioassay development and validation.

Final Agenda

Recommended Short Course*

SC16: New USP Initiatives for Characterization and Release of Biologics - Detailed Agenda

*Separate registration required

THURSDAY, MAY 4

Bioassay Strategies for Cancer Therapies

12:00 pm Registration

12:35 Luncheon in the Exhibit Hall with Poster Viewing

1:40 Chairperson’s Remarks

Natko Nuber, Ph.D., Laboratory Head, BTDM-BPD, Novartis Biologics R&D, Novartis

1:50 Implementing Bioassays for a kλ-Body

Marie Kosco-VilboisMarie Kosco-Vilbois, Ph.D., CSO, Novimmune SA

A comprehensive suite of highly sensitive and complementary binding and reporter gene assays have been implemented to assess the potency of a kλ-Body as part of product quality analysis and characterization studies. Results obtained using the different assays were correlated to demonstrate the assays’ stability indicating properties, locate degradations and initiate the identification of critical quality attributes.

2:20 Development and Optimization of Cell-Based Bioassays for Novel Cancer Immunotherapy

Natko_NuberNatko Nuber, Ph.D., Laboratory Head, BTDM-BPD, Novartis Biologics R&D, Novartis

An ideal bioassay should mimic the MoA and be able to detect changes in the integrity of the drug. Results obtained development and optimization of commercially available bioassays for cancer immunotherapy drugs will be presented. Ability of these, cell based, bioassays to detect stressed material was assessed in comparison to standard binding assays.

2:50 Design, Develop and Optimize MOA Reflective Potency Assays for Immunomodulatory Biologics

Shihua_LinShihua Lin, Ph.D., Senior Scientist, Analytical Biotechnology Development, MedImmune LLC

Immunotherapy is now a promising approach for the treatment of cancer and autoimmune diseases. Bioassay plays an important role in the development of product and manufacture process. This presentation will highlight general consideration on the design, development and optimization of mechanism of action (MOA) reflective and QC-suitable bioassays for potency determination of immunomodulatory biologics.

3:20 Bioassay Design, Development and Validation

John A. Garza, Ph.D., Development Scientist II, Analytical Sciences, Alexion Pharmaceuticals

Several aspects of bioassay design should be taken into consideration during assay development and through validation. Quality Control laboratories and practices as should be considered during the fundamental bioassay design. Additionally, understanding and interpretation of regulatory guidance expectations is key.

3:50 Refreshment Break

4:20 Bioassay Development and Validation Strategies for Antibody-Drug Conjugates

Adrienne Wildt, Ph.D., Senior Scientist, Bioanalytical Science, ImmunoGen

Antibody-drug conjugates (ADCs) represent an increasingly important approach to cancer treatment by targeting the delivery of cytotoxic agent to tumor cell type of interest. ADCs are generally complex heterogeneous mixtures of multiple in vivo drug species and present unique challenges to bioassay development. We will present some examples from our experience in the development of bioassays for the measurement of a new class of payloads from biological matrices.

4:50 Discussion Panel: Bioassay Strategies for Cancer Therapies

  • Unique challenges when working with immunotherapies, ADCs and bispecifics
  • Evaluating MoA
  • Determining potency

Moderator:

Natko Nuber, Ph.D., Laboratory Head, BTDM-BPD, Novartis Biologics R&D, Novartis

Panelists:

Isam Qahwash, Ph.D., Manager, Bioassay Development, Molecular and Analytical Development, Bristol-Myers Squibb

Shihua Lin, Ph.D., Senior Scientist, Analytical Biotechnology Development, MedImmune LLC

Adrienne Wildt, Ph.D., Senior Scientist, Bioanalytical Science, ImmunoGen

Marie Kosco-Vilbois, Ph.D., CSO, Novimmune SA

5:20 End of Day

5:20 Registration for Dinner Short Courses

Recommended Dinner Short Course*

SC19: Strategic Bioassay Design and Analysis - Detailed Agenda

*Separate registration required

FRIDAY, MAY 5

8:00 am Morning Coffee

Bioassay Strategies for Bispecifics

8:30 Chairperson’s Remarks

Michael ToveyMichael Tovey, Ph.D., INSERM Director, Research, Laboratory of Biotechnology & Applied Pharmacology, Ecole Normale Supérieure de Cachan


8:35 SPR-Based Assays Enable the Full Functional Analysis of Bispecific Molecules

Joerg_S_MoellekenJoerg Moelleken, Ph.D., Senior Scientist, Roche Pharmaceutical Research and Early Development, Large Molecule Research, Roche Innovation

We have developed an alternative SPR-based assay principle, which allows the individual assessment of both targets in solution. Comparison of data between the assays showed that simultaneous binding can be calculated based on both individual readouts, and revealed a good correlation. Hence, both SPR-based assay principles allow a “full” functional analysis of a bispecific CrossMab in only one assay. The assay principles can be qualified and enable an efficient drug development.

9:05 Development of Synergistic Cell-Based Assay for Bispecifics

Piyush_VyasPiyush M. Vyas, Ph.D., Senior Research Scientist, Bioassay Development, Eli Lilly and Company

We developed a synergy cell-based assay for one of our bispecific antibodies as we have seen in vivo synergy with this molecule in our preclinical animal model. We were able to identify the optimum conditions to achieve our goal where we were able to determine the response from both the targets in a single cell-based assay. Data analyses of such efficacy data was challenging as the traditional model cannot fit such data. Novel mathematical approach is used to determine the synergy of such bispecific antibodies.

9:35 Bioassay Design, Development and Validation

John A. Garza, Ph.D., Development Scientist II, Analytical Sciences

 

Several aspects of bioassay design should be taken into consideration during assay development and through validation. Quality Control laboratories and practices as should be considered during the fundamental bioassay design. Additionally, understanding and interpretation of regulatory guidance expectations is key.

e developed a synergy cell-based assay for one of our bispecific antibodies as we have seen in vivo synergy with this molecule in our preclinical animal model. We were able to identify the optimum conditions to achieve our goal where we were able to determine the response from both the targets in a single cell-based assay. Data analyses of such efficacy data was challenging as the traditional model cannot fit such data. Novel mathematical approach is used to determine the synergy of such bispecific antibodies.

10:05 Coffee Break

Optimizing Assay Development and Determining Potency

10:35 FEATURED PRESENTATION: Conformationally Selective Biophysical Assay for Influenza Vaccine Potency Determination

YingXia_WenYingxia Wen, Ph.D., Director, Head, Protein Chemistry, Seqirus

Influenza vaccines are the primary intervention for reducing the health burden from influenza. HA is the most important influenza vaccine antigen. Inactivated influenza vaccines are formulated, released for clinical use, and tested for stability based on an in vitro potency assay, SRID. We demonstrate that trypsin digestion, to pre-select immunologically active HA, followed by quantification by RP-HPLC is a promising alternative in vitro potency assay for influenza vaccines.

11:05 Development and Automation of Cell-Based Assays for Biologics

Natalia_KozhemyakinaNatalia Kozhemyakina, Ph.D., Head, Bioassay Laboratory, Analytical Development Department, BIOCAD

Main problems of cell-based potency assays are variability and complexity. Classical potency assay presents a lot of drawbacks that could be overcome by automation. The use of automatic station for cell-based assays allows reduction of procedure time and implementation of complex designs. It significantly reduces variability and facilitates assay development and validation. This talk will present case studies of potency assays for bispecific and monoclonal antibodies with the use of automation.

11:35 A Novel System for Improved Quantification of ADCC Activity

Michael Tovey, Ph.D., INSERM Director, Research, Laboratory of Biotechnology & Applied Pharmacology, Ecole Normale Supérieure de Cachan

Novel target cells, together with homologous control cells, have been developed for the quantification of the ADCC activity of rituximab, trastuzumab. cetuximab and TNFα antagonists. The ADCC activity of the TNF antagonist infliximab has been quantified in serum samples from patients with Crohn’s disease and that of adalimumab and etanercept in patients with rheumatoid arthritis with a high degree of precision and with minimal interference from human serum.

12:05 pm Strategic Design and Analysis for Bioassays

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

While combining data from replicate assays is a simple way to improve the properties of reportable values, there are other methods to consider. A review of what is known about bioassays (including how they are both inherently robust and non-robust) leads to suggested targets to focus on to improve assays, strategies for design and analysis of bioassays, wise choices for assay acceptance criteria, and good choices among measures to use to monitor assays. Modular design of bioassays and appropriate analyses support efficient and flexible procedures for development and validation. Further, if validation is focused on documenting the performance properties of the core modules of the bioassay, a single validation experiment and analysis can then support a variety of ways to use these modules to produce reported values with properties appropriate for each of many different intended uses.

12:35 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:05 Refreshment Break

Lifecycle Management and Statistical Analysis

1:35 Chairperson’s Remarks

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

1:40 Challenges When Transferring NAb Assays to CROs

Linlin_LuoLinlin Luo, Ph.D., Senior Research Investigator, BMS

Cell-based neutralizing antibody (NAb) assay posts many challenges in assay development, validation and execution. Extra considerations need to be given during a NAb assay transfer to contract research organization (CRO) labs, including but not limited to work cell bank preparation and qualification, sample pretreatment to increase drug tolerance, proper analyst training, and prompt communication. I will discuss the lessons learned and pitfalls to avoid from our NAb assay transfer experience.

2:10 Lifecycle Management for Bioassay Development and Validation

Steven_WalfishSteven Walfish, Ph.D., Principal Science & Standards Liaison, USP

Lifecycle management for bioassay development starts with procedure design and continues through validation based on QbD. The concept of QbD is understood as a systematic approach that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management (ICH Q8). An overview of variability and measurement uncertainty to align decisions with results generated by a procedure.

2:40 Tips and Tricks to Develop and Validate a Bioassay According to the USP Approach

Annemie Wielantael, Scientist, Bioassay Development, UCB

Biological activity is a critical quality attribute for biopharmaceutical products, and relative potency bioassays are generally used to accurately determine this activity. Case study will go through the method development journey: from the development itself to the tools implemented to monitor the method performance using the latest recommendations from the USP.

3:10 Statistical Considerations regarding Assay Robustness Studies

Ryan X Yamagata, Principal Statistician, Tech R&D, GlaxoSmithKline Vaccines

Robustness is an important aspect for analytical methods. Guidelines have always encouraged assessing robustness before method validation. In practice, however, robustness studies have often been included in a not-too-rigorous manner during assay validation. With an increased focus on QbD, we have revisited the concept of method robustness, spread across different stages of method development. We will present different ways how robustness can be assessed and which statistical methods are employed.

3:40 End of Conference


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