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Key Sessions

Ph.D Cara Fiore

Keynote Address - New Insights on Expedited Review Programs

Us Food and Drug Administration, Center for Biologics Evaluation and Research (CBER)

7 am 8 am (60 mins)

Coffee and Registration

8 am 8:05 am (5 mins)

Chairman’s Opening Remarks

  • Speaker Joseph Kutza

8:05 am 8:40 am (35 mins)

Keynote Address - New Insights on Expedited Review Programs

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

8:40 am 9:15 am (35 mins)

Keynote Address-From Development to Commercial-Evolution of Analytical Methods to Support the Control Strategy

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

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

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

The industrial manufacturing of a monoclonal antibody is generally preceded by a process development phase.  During this time, it is crucial to achieve sufficient understanding of the design-space and its impact on the product specifications.  Mass spectrometry is a powerful tool for the monitoring of critical quality attributes related to a typical bioproduction, however, fully integrated analytical platforms have been elusive,

We present here a standalone analytical platform developed for the direct connection of a bioreactor to an MS system, for real time, at-line, monitoring of mAb CQAs.

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

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

Workshop # 2

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

Chairperson

  • Joseph Kutza

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

NEW DATA- Integrated Methods for Fingerprint Analysis of Recombinant Proteins

There is much interest in the development and implementation of “fingerprinting” of proteins.  This has been driven by the introduction of biosimilars. As described, the fingerprint assesses a number of product attributes in a sensitive manner using orthogonal methods.  We demonstrate the use of 2D LC hyphenated to MS and other assays as a viable platform to assess multi-attribute parameters.

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

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

NEW DATA Investigation of Antibody Carbonylation during Process Development

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

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

Analytical Methods for the Characterization of Glycated Monoclonal Antibodies

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

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

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

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

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

Development of Bioassays for T-cell Dependent Bispecific Molecules

T-cell dependent bispecific antibodies (TDBs) are able to recruit and activate host T-cells to kill the cancer cells. There are traditional bioassays available to measure T-cell activation such as PBMC-based methods, FACS-based methods, and ELISA with secreted cytokines, but unfortunately most of them are highlyvariable and/or time consuming. Here we present our bioassay strategy forT-cell dependent bispecific molecules. We will cover potency assay strategyusing reporter cell lines and bridging binding assay format. T-cell activation assay detecting a CD3 homodimer and other impurities activating T-cell intarget-independent ways will be discussed as well. Our assay formats are MoAreflective, and were found to be accurate, precise and user-friendly with short assay turn around time. These assays are being further assessed for their suitability for use in support of lot release testing and process impurity testing.

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

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

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

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

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

Manufacturability Evaluation by High Throughput ForceDeg and Assays

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

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

Development of a Dual-Potency Method for an Fc-Fusion Antibody using Bio-Layer Interferometry

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

1:30 pm 2 pm (30 mins)

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

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

TBD

1:30 pm 2 pm (30 mins)

NEW DATA/CASE STUDY- Impact of Drug Product Configurations and Components on Subvisible Particle Counts of a mAb

Drug product container closure components have been shown to potentially impact quality attributes of biopharmaceutical products.  Silicone oil is typically coated onto components to aid in manufacturability and for ease of use, however, it has also been implicated in expediting aggregation and sub-visible particle formation under various stresses encountered by the drug product.  In this presentation, the impact of silicone oil (from siliconized stopper) on product quality and effectiveness of surfactant as a formulation control on an IgG1 mAb was examined. The presentation will explain the impact of container closure components and the role of surfactant on stability of the molecule during transportation and storage. 

  • Suzanne Hudak, Scientist, Formulation Sciences, MedImmune

2 pm 3:05 pm (65 mins)

Characterization of Biologics Formulations for Assurance of Successful Use in Downstream Process for quality Performance in Clinical Immunodiagnostic Assays

  • Tracey Rae, Senior Scientist Analytical Chemistry, Abbott

3:05 pm 3:30 pm (25 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 pm 3:05 pm (65 mins)

CASE STUDY: An Integrated Approach to Managing Immunogenicity Risk and Drug Immune Modulation

  • Dr. Emilee Knowlton, Immunology Sales Specialist, ProImmune Inc.

3:05 pm 3:30 pm (25 mins)

Aggregation of Biotherapeutics in Human Plasma- Impact of Molecule Structure and Formulation

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

3:30 pm 4 pm (30 mins)

Regulatory Guidance for Bioassay Development and Validation

4 pm 5 pm (60 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 5:30 pm (60 mins)

Characterization Strategies from Pfizer's ADC Portfolio

  • April Xu, Sr. Principal Scientist, Pfizer

4 pm 4:30 pm (30 mins)

Overview of Analytical Characterization Methods used to Demonstrate Comparability of Human Papillomavirus Containing Vaccines

  • Carol Shultz, PhD., Associate Principal Scientist, 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

5:15 pm 6:45 pm (90 mins)

Networking Reception

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