Optimizing Bioassays for Biologics conference, May 7-8 2020


New therapeutic modalities, including cell & gene therapies, immunotherapies, and antibody therapies, continue to push the limit on bioassay development and implementation. New formats present challenges including determining what reference materials to use and how to validate the assay. Standards are advancing, but questions remain around the regulatory framework for assays. At the 6th Annual Optimizing Bioassays for Biologics conference, bioassay experts will address the top challenges in bioassay design including lifecycle management, validation, assay bridging, standards, and developing reference materials. Case studies and best practices for handling the most common issues in biological assay design will be presented with a focus on cell & gene therapies.

Thursday, September 3

NOVEL ASSAY TYPES

12:45 pm

Bioassay Strategies for Innovative Molecules

Natalia Kozhemyakina, PhD, Head, Bioassay, BIOCAD

Biological activity is a critical authenticity and quality attribute of biologics. It is extremely important to be sure that we create methods that reflect molecule mode of action, especially in case of multiple MoA, and at the same time is sufficiently precise and accurate. It is well known how potency assay can be variable, laborious, and time consuming with its long multi-stage protocols. The presentation provides case studies of development strategies for innovative molecules and highlights best practices for handling the most common issues in biological assay development.

1:05 pm

Uh-Oh, Our Primary Standard Isn’t Stable: What Do We Do Now?

David Lansky, PhD, President, Precision Bioassay, Inc.
1:25 pm LIVE Q&A:

Session Wrap-Up

Panel Moderator:
Kaitlyn Barago, Assoc Dir, Production, Cambridge Healthtech Institute
Panelists:
David Lansky, PhD, President, Precision Bioassay, Inc.
Natalia Kozhemyakina, PhD, Head, Bioassay, BIOCAD
1:45 pm Refresh Break - View our Virtual Exhibit Hall

STANDARDS AND REGULATORY CONSIDERATIONS

2:25 pm

Chairperson's Remarks

Steven Walfish, Principal Scientific Liaison, Global Science & Standards, USP
2:30 pm

Principles and Practices for Bioassay Standards

Tim Schofield, Owner & Consultant, CMC Sciences LLC

Standards are essential to the development and control of biological products. Considering their importance, there is no consensus on the source of a standard, the basis and means of standard qualification, and stability evaluation. This talk will discuss principles and practices related to standards used to report potency of biological products and propose strategies. Those proposals will borrow from practices related to quality by design, highlighting fitness-for-use of a standard.

2:50 pm

Current Efforts in Bioassay Standardization

Dawn Henke, PhD, Senior Technical Program Manager, Standards Coordinating Body

This discussion will cover standards for regenerative medicine products. Discussion will focus on standards for bioassays, published standards and how to implement these standards be addressed. An overview of current standards under development and how to get involved, as well as a forum for questions will be provided.

3:10 pm PANEL DISCUSSION :

Standards and Regulatory Considerations

Panel Moderator:
Steven Walfish, Principal Scientific Liaison, Global Science & Standards, USP
Panelists:
Dawn Henke, PhD, Senior Technical Program Manager, Standards Coordinating Body
Tim Schofield, Owner & Consultant, CMC Sciences LLC
3:50 pm Close of Day

Friday, September 4

BIOASSAY DEVELOPMENT FOR INSULIN

9:00 am

Chairperson's Remarks

Marla Abodeely, PhD, Director of Bioassay, Analytical Sciences & Technology, Sanofi
Carole A.C. Sourbier, PhD, Principal Investigator, Office of Biotechnology Products, OPQ, FDA CDER

The Biologics Price Competition and Innovation Act was passed as part of the Affordable Care Act and under that law, insulins will be regulated as biologics in March 2020. Under the regulations for Biologics License Application review, it is expected that the potency of the insulins and of their associated biosimilars will be assessed quantitatively in a cell-based assay or bioassay that, ideally, represents the product mechanism of action. Currently, the USP is recommending an in vivo rabbit bioidentity test for the assessment of the biological activity of insulins. However, reduction in animal experiments is a worldwide goal for many and it is likely that in vitro bioassays will be submitted for assessing the potency of insulins products. This research talk will highlight some of the aspects of metabolic functional assays to think about during development and product characterization for insulin products and for antibodies that target metabolic pathways.

9:25 am

Development of a Robust Functional Cell-Based Assay for Replacing the Rabbit Blood Sugar Bioidentity Test of Insulin Analog

Junming Yie, PhD, Principal Scientist, Biologics Analytical, Merck

A rabbit blood sugar bioidentity assay is required by the FDA to evaluate biological activity for insulin analogs per USP<121> guideline. Not only are a large number of live animals used, but the method is also highly variable and expensive. A reporter cell-based assay was developed by utilizing insulin’s role in regulating hepatic gluconeogenesis pathway. This functional assay was qualified to demonstrate its performance in linearity, accuracy and precision, and was further evaluated on its robustness using design-of-experiment (DoE) approach. Lastly, it was compared with an established insulin receptor phosphorylation assay to demonstrate its superior performance.

9:45 am LIVE Q&A:

Session Wrap-Up

Panel Moderator:
Marla Abodeely, PhD, Director of Bioassay, Analytical Sciences & Technology, Sanofi
Panelists:
Carole A.C. Sourbier, PhD, Principal Investigator, Office of Biotechnology Products, OPQ, FDA CDER
Junming Yie, PhD, Principal Scientist, Biologics Analytical, Merck
10:05 am Session Break
10:30 am Speed Networking Coffee Break - View our Virtual Exhibit Hall

CASE STUDIES IN BIOASSAY DEVELOPMENT

10:45 am

Chairperson's Remarks

Steven Walfish, Principal Scientific Liaison, Global Science & Standards, USP
10:50 am KEYNOTE PRESENTATION:

Best Practices in Bioassay Development to Support Registration of Biopharmaceuticals

Marla Abodeely, PhD, Director of Bioassay, Analytical Sciences & Technology, Sanofi

Biological activity is a critical quality attribute for biopharmaceuticals which is accurately measured using an appropriate relative potency bioassay. Developing a bioassay is a complex, rigorous undertaking that needs to address a number of challenges including modelling all of the mechanisms of action associated with the biotherapeutic. Bioassay development is also an exciting and fast evolving field, not only from a scientific, medical and technological point of view, but also in terms of statistical approaches and regulatory expectations. This has led to an industry-wide discussion on the most appropriate ways to develop, validate and control the bioassays throughout the drug lifecycle.

11:10 am

Statistical Model Selection Using USP <1034>

Steven Walfish, Principal Scientific Liaison, Global Science & Standards, USP

Relative potency is a measure obtained from the comparison of a test sample to a standard based on the capacity to produce the expected biological activity. USP <1034> presents several different models and suitability criteria to determine the reliability of the estimate. This talk will cover traditional linear and non-linear bioassay models with an emphasis on model suitability including parallelism.

11:30 am

Measurement Assurance, Control Strategies and Documentary Standards for the Development of Bioassays for Cell Therapy

Sumona Sarkar, PhD, Biomedical Engineer, Biosystems and Biomaterials Division, Biomaterials Group, National Institute of Standards and Technology
11:50 am

Critical Reagents Characterization Strategy to Support Biologics/Vaccines Projects at Regulated Bioanalysis

Kun Yang, PhD, Associate Principal Scientist, PPDM, Merck Research Labs

At the heart of bioassays for biologics are critical reagents used to directly or indirectly measure biologic markers or signals. A comprehensive analytical toolbox of biochemical, functional and biophysical methods (UPLC-SEC, IEX, RP, HIC, CE, icIEF, Octet, and HRMS) has been developed to evaluate the quality of critical reagents. Several case studies, including reagents, troubleshooting and comparison of small scale hybridoma and large-scale recombinant protein, lifecycle management of biologics, developing reference material, emerging standards and regulatory frameworks, will be presented.

12:10 pm LIVE Q&A:

Session Wrap-Up

Panel Moderator:
Steven Walfish, Principal Scientific Liaison, Global Science & Standards, USP
Panelists:
Marla Abodeely, PhD, Director of Bioassay, Analytical Sciences & Technology, Sanofi
Sumona Sarkar, PhD, Biomedical Engineer, Biosystems and Biomaterials Division, Biomaterials Group, National Institute of Standards and Technology
Kun Yang, PhD, Associate Principal Scientist, PPDM, Merck Research Labs
12:30 pm Close of Summit





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