Analytical Characterization - Day 1


Analytical Characterization

This exciting new event covers advanced technologies for physicochemical and biological characterization for a range of complex therapeutic proteins to provide a fuller understanding of the product, to ensure safety and efficacy, and to facilitate smooth and efficient interaction with the regulatory authorities. It focuses on advances in mass spectrometry, post-translational modifications, bioassays, characterization of impurities, and regulatory perspectives. The emphasis is on case studies, practical application, technology transfer and on fulfilling regulatory expectations.

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Monday, April 4

12:00 pm Registration

 

REGULATORY CONCERNS

1:50 Chairperson’s Opening Remarks

Tina S. Morris, Ph.D., Vice President, Biologics & Biotechnology, USP

KEYNOTE PRESENTATION

2:00 Regulatory Expectations Regarding Application of New and Advanced Technologies

Emily_ShacterEmily Shacter, Ph.D., Chief, Laboratory of Biochemistry, Division of Therapeutic Proteins, Office of Biotechnology Products, FDA/CDER/OPS, FDA

 

UPDATE ON BIOASSAYS FROM INDUSTRY LEADERS

2:30 Bioassay Transitions – Experiences in the Compendial Setting

Tina_MorrisTina S. Morris, Ph.D., Vice President, Biologics & Biotechnology, USP

With increasing frequency, especially for legacy biologics, animal assays are being replaced by in vitro assays of different formats. This transition is not always straightforward, as analysts may struggle to establish equivalence between assays that measure different attributes or sets of attributes. This presentation will focus on USP’s current efforts to include modern in vitro assays in the USP-NF to replace animal-based tests for well-characterized biologics.

 

3:00 Networking Refreshment Break with Exhibit and Poster Viewing

3:30 Strategies for Establishing MOA Reflective and Robust Bioassays Early in Support of Product Development Life Cycle

Xu-Rong_JiangXu-Rong Jiang, Ph.D., M.D., Associate Director, Analytical Biochemistry, MedImmune, LLC

Development of a robust and sensitive bioassay that reflects the mechanism of action of the molecule continues to be a significant industry challenge. This presentation discusses a strategy to overcome these challenges by combining a platform bioassay approach with the use of multivariate experiment design to provide more robust and relevant bioassays. Case studies are discussed showing the practical application of this strategy for several therapeutic monoclonal antibodies.

4:00 Advances in in vitro Bioassays for Specifications and Release, and for Stability and Comparability Studies

Jane_RobinsonC. Jane Robinson, Ph.D., Biotherapeutics, National Institute for Biological Standards and Control, Health Protection Agency, UK

As techniques such as reporter gene assays, RT-PCR and BRET/FRET progress from research into routine use, they can permit improvements in robustness and precision. Binding assays normally provide data complementary to functional bioassays, but can, for some products, provide a substitute for the functional bioassay. Examples of a selection of bioassays will be discussed.

4:30 Experiences with Technology Transfer of a Cell-based Potency Assay to a European CRO

Shi_LimingLiming Shi, M.A., M.Sc., Senior Scientist, Bioanalytical Chemistry, Amylin Pharmaceuticals, Inc.

This presentation will address the regulatory challenges that result from the absence of clear guidance for cell-based potency assay validation; technical issues regarding training, qualification and validation, such as sites bias comparability, statistical powerful experimental design, the parallelism test for full curve analysis, and variance model build-up for weighting; and lastly, the application of powerful statistical tools for data mining during trouble shooting.

 

         Sponsored by
Waters_Black_with_tagline 
5:00 Deploying High Resolution Protein Analytics across Biopharma Organizations: New Technologies, Informatics, and Compliance
Jeffrey R. Mazzeo, Ph.D., Biopharmaceutical Business Director, Waters Corporation
Waters focuses on delivering innovative technology solutions that are purposely developed for the biopharmaceutical industry. We seek to understand the future needs of laboratories like yours where multiple departments and outsourcing vendors need improved tools to share information and transfer methods and technologies. This seminar will focus on how the integration of Waters UPLC, MS, and bioinformatics technologies will enable your laboratory to extract the maximum amount of qualitative and quantitative information from biotherapeutic samples. We will discuss how high-resolution analytical characterization can deliver business advantages from discovery through regulated development and QC environments.

5:30 – 6:30 Networking Reception with Exhibit and Poster Viewing

6:30 End of Day One



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