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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, Ph.D., Scientist, Analytical Chemistry, Regeneron Pharmaceuticals, Inc.

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

Keynote Address - New Insights on Expedited Review Programs

  • Cara Fiore, Ph.D., 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

During the industrial manufacturing of a monoclonal antibody 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, Ph.D., Market Area Manager – BioPharma, Bruker Daltonics Inc.

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

Let UNcle Tell You the Whole (Stability) Story

  • Dina Finan Ph.D., Applications Scientist, Unchained Labs

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

Networking Refreshment Break in the Poster & Exhibit Hall

10:40 am 10:45 am (5 mins)

Chairperson's Remarks

  • Joseph Kutza

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

Replacing Analytical Methods for Release and Stability Testing – A Regulatory Perspective

  • Speaker Lokesh Bhattacharyya, Laboratory of Analytical Chemistry and Blood Related Products, US FDA

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, Ph.D., Principal Scientist, BioProcess Development-MRL, Merck & Co.

10:40 am 10:45 am (5 mins)

Chairperson's Remarks

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

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

Development of Bioassays for T-cell Dependent Bispecific Molecules

  • Ho-Young Lee, Ph.D., 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

The amount of gene therapy-related research and development occurring in the US and worldwide continues to grow at a fast rate. In recent years, recombinant adeno-associated viral (AAV) vectors have been exploited in a number of gene delivery approaches. The use of these vectors in clinical applications has increased the demand for the manufacture, characterization, and quality control of AAV-based drug products. A notable feature of AAV vector generation in cell culture is the formation of an excess of “empty” capsids, which lack the vector genome and are therefore unable to provide a therapeutic benefit. The effect of the empty capsids on clinical outcome is unclear, as there is some indication of increased immunogenicity, but also possibly enhanced gene transfer as a function of the amount of empty capsids in the drug product.

While the ultimate effect of empty capsids---and other impurities associated with AAV production---on safety and efficacy is yet to be fully established, an accurate and precise means of characterization of the relative abundance of variants in AAV drug products will be a necessary feature in the development of this class of biologics. In this presentation, we explore the use of analytical ultracentrifugation (AUC) in the characterization of the size-distribution profile of species in recombinant AAV samples. In particular, we discuss the applicability of band-forming sample loading, which may greatly reduce the sample amount requirements, and facilitate the use of AUC as a sensitive, precise method for the characterization of AAV purity.

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

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

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

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

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

  • Speaker Lokesh Bhattacharyya, Laboratory of Analytical Chemistry and Blood Related Products, US FDA

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

Purification of glycoproteins is commonly performed using plant-lectin-affinity chromatography, however, this purification method is difficult to scale-up to manufacturing. Here we describe the use of Bio-Layer Interferometry as a screening tool to evaluate glycoprotein variants purified by recombinant plant lectin (RPL) chromatography columns. These RPL columns are easily scalable, and are capable of purifying the active species of glycoproteins based on different sugar residues. Furthermore, we have developed a BLI method to determine the Dual-Potency of a protein capable of binding to multiple antigens.

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

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

Chairperson's Remarks

  • Bernice Yeung, Ph.D., Director of Analytical Development, Analytical Development, Shire

1:30 pm 2 pm (30 mins)

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

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

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, Ph.D., Senior Scientist, Attribute Sciences, Process Development, Amgen Inc

2 pm 2:30 pm (30 mins)

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

Immunogenicity is one of the most complex issues to address in drug design and development. Integrated platforms such as, Mass Spectrometry antigen presentation assays; DC-T and T cell proliferation assays for biologic lead selection/optimization; HLA-peptide binding assays to characterize individual epitopes and undiluted whole blood cytokine storm assays, can be used to mitigate immunogenicity risk and characterize immune responses directed toward biologics.

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

2:30 pm 3 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 pm 3:30 pm (30 mins)

TESTING IMPACTS OF PROTEIN VARIANTS ON IMMUNOGENICITY

  • Hsiaoling Wang, Ph.D., Laboratory of Analytical Chemistry and Blood Related Products, US Food and Drug Administration, Center for Biologics Evaluation and Research (CBER)

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, Ph.D., Microbiologist, 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, Ph.D., Staff Scientist, Analytical Development, Vaccine Production Program, Vaccine Research Center/NIAID/NIH

5:30 pm 6:30 pm (60 mins)

Networking Cocktail Reception in the Poster & Exhibit Hall