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Key Sessions

Elisabeth Krug

New Data/Case Study: Keynote Address - From Development to Commercial – Evolution of Analytical Methods to Support the Control Strategy

Eli Lilly & Company

7 am 8 am (60 mins)

Coffee and Registration

8 am 8:15 am (15 mins)

Chairperson's Opening Remarks

  • Joseph Kutza

8:15 am 8:45 am (30 mins)

New Data/Case Study: Keynote Address - From Development to Commercial – Evolution of Analytical Methods to Support the Control Strategy

  • Elisabeth Krug, BR&D Analytical Development, Eli Lilly & Company

8:45 am 9:15 am (30 mins)

New Data/Case Study: Keynote Address - Leveraging Multiple Attribute Monitoring (MAM) to Support Process Development

  • Xiaobin Xu, PhD., Scientist, Analytical Chemistry, Regeneron Pharmaceuticals, Inc.

9:15 am 9:45 am (30 mins)

Keynote Address - New Insights on Expedited Review Programs

  • Ph.D Cara Fiore, Master Reviewer, Us Food and Drug Administration, Center for Biologics Evaluation and Research (CBER)

9:45 am 10:15 am (30 mins)

Semi-Automated, Mass Spectrometric Determination and Evaluation of Glycosylation CQAs at the Bioreactor Level

  • Jason Wood, PhD., Market Area Manager – BioPharma, Bruker Daltonics Inc.

9:45 am 10:15 am (30 mins)

Presentation Title TBD

Unchained Labs Presenter

10:15 am 10:45 am (30 mins)

Networking Refreshment Break in the Poster & Exhibit Hall

10:45 am 11:15 am (30 mins)

New Data: Integrated Methods for Fingerprint Analysis of Recombinant Proteins

  • Darryl Davis, PhD., Associate Director, Analytical, Janssen R&D LLC

11:15 am 11:45 am (30 mins)

New Data: Investigation of Antibody Carbonylation during Process Development

  • Yi Yang, MSc., Scientist, Protein Analytical Chemistry, Genentech Inc

11:45 am 12:15 pm (30 mins)

New Data/Case Study: Analytical Methods for the Characterization of Glycated Monoclonal Antibodies

  • Soundara Soundararajan PhD., Principal Scientist, BioProcess Development-MRL, Merck & Co.

10:45 am 11:15 am (30 mins)

Development of Bioassays for T-cell Dependent Bispecific Molecules

  • Dr. Ho-Young Lee, Scientist, ADQC/Biological Technologies, Genentech

11:15 am 11:45 am (30 mins)

Analytical Ultracentrifugation Assays for the Characterization of Purity in AAV Gene Delivery Vectors

  • Christopher Sucato, Senior Scientist, Biophysical Characterization, Charles River Laboratories

11:45 am 12:15 pm (30 mins)

Manufacturability Evaluation by High Throughput ForceDeg and Assays

  • Zhenyu Gu, Scientist III, Global Analytical and Pharmaceutical Development, Alexion Pharmaceutical

12:15 pm 1:25 pm (70 mins)

Luncheon & Roundtable Discussions in the Poster & Exhibit Hall

1:25 pm 1:30 pm (5 mins)

Chairperson's Remarks

1:30 pm 2 pm (30 mins)

New Data: New Analytical Approaches for the Characterization of Antibodies and Antibody-Like Molecules

  • Ph.D. Chris Chumsae, Senior Scientist III, Protein Analytics, Process Sciences, AbbVie

1:30 pm 2 pm (30 mins)

Development of a Dual-Potency Assay and the Use of BLI as a Screening Mechanism to Evaluate Recombinant Plant Lectins as a Glycoprotein Purification Tool

  • Carson Cameron, M.S., Analytical Development Associate, KBI Biopharma Inc

2 pm 2:30 pm (30 mins)

New Data: Development of Rapid Ultra-Sensitive Assay for Free Thiol Determination and Characterization of a Therapeutic Antibody Fragment

  • Ph.D Weitao Jia, Protein Analytical Chemistry-2, Pharma Technical Development, Genentech Inc

2 pm 2:30 pm (30 mins)

New Data/Case Study: Impact of Drug Product Configurations and Components on Subvisible Particle Counts of a mAb

  • Suzanne Hudak, Scientist, Formulation Sciences, MedImmune

2:30 pm 3 pm (30 mins)

New Data/Case Study: Characterization of Biologics Formulations for Assurance of Successful Use in Downstream Processes for Quality Performance in Clinical Immunodiagnostic Assays

  • Tracey Rae Ph.D., Principal Scientist, Abbott Diagnostics R&D, Research Analytical Chemistry, Abbott

3 pm 3:30 pm (30 mins)

Phase Appropriate Stability and Comparability Strategies to Accelerate Introduction of New Modalities into the Clinic

  • Dr. Ranjini Ramachander, Senior Scientist, Attribute Sciences, Process Development, Amgen Inc

2:30 pm 3 pm (30 mins)

Case Study: An Integrated Approach to Managing Immunogenicity Risk and Drug Immune Modulation

  • Emilee Knowlton Ph.D., Immunology Sales Specialist, ProImmune Inc.

3 pm 3:30 pm (30 mins)

New Data/Case Study: Aggregation of Biotherapeutics in Human Plasma - Impact of Molecule Structure and Formulation

  • Tudor Arvinte Ph.D., Professor, Chairman, CEO, Therapeomic Inc.

3:30 pm 4 pm (30 mins)

Networking Refreshment Break in the Poster & Exhibit Hall

4 pm 4:30 pm (30 mins)

New Data/Case Study: Application of Spectral Deconvolution and the Impact of Payload Conjugation Chemistry on the Tertiary Structure of Antibody Drug Conjugates

  • Arun Parupudi, Associate Scientist II, MedImmune

4:30 pm 5 pm (30 mins)

New Data/Case Study: Characterization Strategies from Pfizer’s ADC Portfolio

  • April Xu, Ph.D., Senior Principal Scientist, Byx-ARD, Pfizer

4 pm 4:30 pm (30 mins)

New Data/Case Study: Overview of Analytical Characterization Methods used to Demonstrate Comparability of Human Papillomavirus Containing Vaccines

  • Carol Shultz, Ph.D., Associate Principal Scientist, Global Vaccine and Biologics Commercialization, Merck & Co.

4:30 pm 5 pm (30 mins)

Analytical Characterization and Potency Assays for Vaccines

  • Goutam Sen, PhD., Scientific Reviewer, Food and Drug Administration, Center for Biologics Evaluation and Research, (CBER)

5 pm 5:30 pm (30 mins)

New Data from NIH on Assay Development Strategies for Vaccines

  • Jonathan Cooper, PhD. , Staff Scientist, Analytical Development, Vaccine Production Program, Vaccine Research Center/NIAID/NIH

5 pm 6 pm (60 mins)

Networking Cocktail Reception in the Poster & Exhibit Hall

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