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Key Sessions

Wen Jin Wu, M.D., Ph.D.

Regulatory Considerations for Antibody-Drug Conjugates and Case Studies

CDER, FDA

Emily Shacter, Ph.D.

Biosimilars: Update on FDA Scientific and Regulatory Expectations for Characterization and Approval

ThinkFDA, LLC

Daniel Lagassé, Ph.D.

Characterization of Fc-Fusion Protein Interactions with the Repertoire of Human Fc-Receptors

U.S. FDA

7:00am - 8:05am

Coffee & Registration

8:05am - 8:10am
Chairperson’s Remarks

Chairperson’s Remarks

Showing of Streams
Showing of Streams
10:10am - 10:40am

Networking Refreshment Break in Poster and Exhibit Hall

Showing of Streams
Showing of Streams
Showing of Streams
2:30pm - 3:00pm

Networking and Refreshment Break in Poster and Exhibit Hall

Showing of Streams
4:30pm - 4:35pm
Close of Conference – See you in 2018!

Close of Conference – See you in 2018!

7:00am - 8:05am 65 mins
Coffee & Registration
8:05am - 8:10am 5 mins
Chairperson’s Remarks
8:10am - 8:40am 30 mins
Plenary Session: FDA Perspective – Physical and Functional Characterization
Regulatory Considerations for Antibody-Drug Conjugates and Case Studies
  • FDA Speaker Wen Jin Wu, M.D., Ph.D. - Senior Investigator, Office of Biotechnology Products/OPQ/OBP, CDER, FDA
more

While ADCs are a rapidly growing area in drug development, no specific regulatory guidance exists for the development of ADCs. FDA follows existing guidelines for both monoclonal antibodies and small molecule drugs to regulate ADCs. Regulatory issues with ADC-specific product quality attributes (QAs) identified in pre-INDs and INDs will be discussed.

8:40am - 9:10am 30 mins
Plenary Session: FDA Perspective – Physical and Functional Characterization
Biosimilars: Update on FDA Scientific and Regulatory Expectations for Characterization and Approval
  • Emily Shacter, Ph.D. - Independent Consultant, ThinkFDA, LLC
more
9:10am - 9:40am 30 mins
Plenary Session: FDA Perspective – Physical and Functional Characterization
Characterization of Fc-Fusion Protein Interactions with the Repertoire of Human Fc-Receptors
  • Daniel Lagassé, Ph.D. - Staff Fellow, Center for Biologics Evaluation and Research, U.S. FDA
more

Fusing the IgG1 constant region (Fc-domain) to therapeutic-proteins increases their plasma half-life via neonatal Fc receptor (FcRn) binding. However, potential interactions with other Fc binding molecules may have immunological consequences. We show that binding-affinities for these interactions are affected by the Fc-fusion partner and advocate a case-by-case characterization of Fc-fusion drug candidates.

9:40am - 10:10am 30 mins
Technology Workshop A
GlycanAssure™: Simple and Sensitive Fully Integrated N-Glycan Analysis Solutions for High Throughput and QC Release Applications
  • Nan Liu, Ph.D. - R&D Scientist, Thermo Fisher Scientific
more

We have improved the N-glycan analysis process at several levels by developing an easy magnetic bead based sample prep that can apply for both LC and CE analytical platforms. On sample prep side, we have reduced overall workflow duration, hands on time, and eliminated lengthy centrifugation, vacuum drying steps and use of toxic chemicals. The magnetic beads-based,  procedure provides streamline workflow for glycoprotein denaturation and deglycosylation, APTS labeling of the released glycans and cleaning of the excess free dyes. This workflow is easy to automate on a cartridge based platform making the overall sample prep hands-free, walkaway solution. Samples from both manual and automated workflow can be analyzed on both high throughput (3500 multi-capillary CE) and UHPLC (Thermo Vanquish) instruments, providing an end-to-end single sample prep solution that can use from high throughput clone selection applications to low throughput drug product QC release applications. In this presentation, N-glycan data generated from both multi-capillary CE and UHPLC will be discussed.

9:40am - 10:10am 30 mins
Technology Workshop B
Technology Workshop Available
more

For more information, contact Kristen Schott • kristen.schott@KNect365.com • 857-504-6685

10:10am - 10:40am 30 mins
Networking Refreshment Break in Poster and Exhibit Hall
10:40am - 10:45am 5 mins
Well Characterized Biologics: Case Studies of Protein Characterization and Product Comparability
Chairperson’s Remarks
10:40am - 10:45am 5 mins
Biological Assays: Bioassay Development for Biosimilars and Complex Molecules
Chairperson’s Remarks
  • David Lansky, Ph.D. - President, Precision Bioassay, Inc.
more
10:45am - 11:15am 30 mins
Well Characterized Biologics: Case Studies of Protein Characterization and Product Comparability
Overview of Analytical Characterization Methods Used to Demonstrate Comparability of Hepatitis A Vaccine
  • Mary Latza, M.S. - Associate Director, Technical Services, Merck & Co., Inc
more

ICH Q5E recommends that chances to manufacturing processes be evaluated via comparability to ensure the quality, safety and efficacy of drug product. Comparability evaluations can be performed by comparing assay results against predefined acceptance criteria/alert levels without requiring clinical trials. A case study focusing on characterization assays performed for the assessment of comparability of Hepatitis A vaccine will be presented.

10:45am - 11:15am 30 mins
Biological Assays: Bioassay Development for Biosimilars and Complex Molecules
Functional Assays for Similarity Assessment of Biosimilars
  • Rajani Srikakulam, Ph.D. - Principal Scientist, Adello Biologics
more

Functional assays or bioassays are an important part of analytical characterization which is the foundation of a biosimilar development program. Biosimilars and their originator drugs are typically large multi-domain molecules with the potential of eliciting a range of biological responses that may be directly or indirectly related to their safety, efficacy and pharmacokinetics. Accordingly, a suite of independent and orthogonal in vitro functional assays are required to address various functional activities of biologic drugs and provide important insights into structural aspects of their binding domains. The complete set of assays needed for biosimilars are molecule specific. An early and thorough understanding of the current knowledge of the innovator molecule is necessary to develop an analytical strategy and determine the relative importance of assays to the stage of biosimilar development. Examples will be presented to illustrate bioassay development for biosimilar candidates with different mechanisms of action.

11:15am - 11:45am 30 mins
Well Characterized Biologics: Case Studies of Protein Characterization and Product Comparability
Comparability Assessment of an Antibody-Drug Conjugate (ADC) for entry into Late-stage Clinical Trial
  • Paul Weisbach - Scientist I, Analytical Pharmaceutical Sciences, ImmunoGen Inc
more

In preparation for commercial launch of an ImmunoGen ADC, changes were made to manufacturing processes of the antibody intermediate (Ab), the ADC drug substance (DS) and ADC drug product (DP). Antibody manufacturing changes were made to increase antibody titer, improve antibody manufacturing robustness, and change antibody storage buffer. DS and DP manufacturing processes were scaled up. The comparability strategy for inclusion of this ADC into PIII clinical studies will be discussed.

11:15am - 11:45am 30 mins
Biological Assays: Bioassay Development for Biosimilars and Complex Molecules
Critical Quality Attributes and Their Functional Analysis for Demonstrating Biosimilarity
  • Patrick Liu, Ph.D. - Sr. Director, Teva Pharmaceuticals
more
11:45am - 12:15pm 30 mins
Well Characterized Biologics: Case Studies of Protein Characterization and Product Comparability
Case Studies of USP’s Compendial Approach to the Analysis of Biotherapeutics
  • Kevin Carrick, Ph.D. - Senior Scientific Liason, Global Biologics, United States Pharmacopeia
more

The USP Global Biologics department develops monographs and associated general chapters in the area of biotherapeutics. Various methodologies are used for the purposes of establishing identity, strength, quality, and purity of biotherapeutics. Chromatography, electrophoresis, and bioassays are examples of methods used to address key quality attributes covered in USP standards.

11:45am - 12:15pm 30 mins
Biological Assays: Bioassay Development for Biosimilars and Complex Molecules
Near-universal Equivalence Bounds for Similarity in Bioassays
  • David Lansky, Ph.D. - President, Precision Bioassay, Inc.
more

Testing for similarity via equivalence tests is an essential part of modern bioassay analyses. Using sensitivity analyses we show 1) that scale-independent measures of non-similarity are near-universal, 2) that neither parameter-specific nor composite measures of non-similarity are sufficient alone to control bias in potency, and 3) how to choose equivalence bounds that will limit bias in potency due to non-similarity.


12:15pm - 1:25pm 70 mins
Luncheon Roundtable A
Lessons Learned from Comparability Assessments of an Established Commercial Vaccine Product
  • Moderator Mary Latza, M.S. - Associate Director, Technical Services, Merck & Co., Inc
more
12:15pm - 1:25pm 70 mins
Luncheon Roundtable B
Statistical Control Charting for Bioassays
  • Moderator Kenneth Miller, Ph.D. - Senior Scientist, Bioassay Development, Analytical Sciences, Biopharmaceutical Development, MedImmune
more
12:15pm - 1:25pm 70 mins
Luncheon Roundtable C
Demonstrating Comparability by Analytical and Biological Assays
  • Moderator Yi Yang, M.S. - Senior Scientist, Genentech Inc
more
12:15pm - 1:25pm 70 mins
Luncheon Roundtable D
Automation of Bioassays
  • Moderator John Lehrach - Research Scientist, Bristol-Myers Squibb
more
12:15pm - 1:25pm 70 mins
Luncheon Roundtable E
Strategies for BLA enabling ADC Characterization
  • Moderator Sunnie Kim, Ph.D. - Senior Scientist, Seattle Genetics
more
1:25pm - 1:30pm 5 mins
Well Characterized Biologics: Analytical Strategies for Stability Studies for Diverse Products
Chairperson’s Remarks
1:25pm - 1:30pm 5 mins
Biological Assays: Method Bridging and Method Tech Transfer for Bioassays
Chairperson’s Remarks
  • John Lehrach - Research Scientist, Bristol-Myers Squibb
more
1:30pm - 2:00pm 30 mins
Well Characterized Biologics: Analytical Strategies for Stability Studies for Diverse Products
Considerations for In-Use Stability Studies for Monoclonal Antibody Therapeutics
  • Suzanne Hudak, M.S. - Scientist, MedImmune
more

Design and execution of the relevant conditions for in-use stability studies for parenteral biological products are critical for ensuring drug efficacy and patient safety. The study should simulate the potential steps and hold times from the start of product preparation through administration of the product. Results from the study are used to determine the relevant information needed for the commercial package insert, such as allowable hold times and acceptable diluents used during administration. This presentation will focus on strategy used for designing an in-use study in the context of expectations from regulatory authorities. A case study on a monoclonal antibody for intravenous infusion will be presented. Stability of the drug product in different diluents and hold times will be discussed, as well as the effect of degradation products from the diluent itself.

1:30pm - 2:00pm 30 mins
Biological Assays: Method Bridging and Method Tech Transfer for Bioassays
Strategies for Bridging Late Phase Cell-Based Potency Assays
  • Amy Teale, Ph.D. - Senior Analytical Scientist, Regeneron Pharmaceuticals
more

Potency assays are one of several analytical methods used to evaluate the functional integrity of biological drug products. Analytical methods are required to assess product quality attributes for biotherapeutics prior to product release. During the lifecycle of a biological product, new or revised analytical methods may be introduced as a replacement to the current method(s) for providing increased efficiency, enhanced quality, and/or greater robustness. In order to replace an analytical method during late stage and post-commercialization, regulatory agencies expect the sponsors to conduct robust method bridging studies to evaluate and demonstrate equivalence between the current and new method(s). Conventionally, method bridging studies include testing of release and stability samples and establishing comparability over time. The extent and duration of the comparability study is largely determined by the drug product’s stage and the nature of analytical method. Method comparability for potency assays remains challenging due to the complexity of the methods themselves and the functional attribute (relative potency) that needs to be bridged. A case study of late phase method bridging between two cell-based potency assays will be presented. Criteria for establishing comparability as well as strategies for, and challenges to, method replacement at different product phases will be discussed.

2:00pm - 2:30pm 30 mins
Well Characterized Biologics: Analytical Strategies for Stability Studies for Diverse Products
Panel Discussion: Defining Minimum Requirements for Stability in a Phase Appropriate Fashion (including late stage)
  • Moderator Ranjini Kaushik, Ph.D. - Senior Scientist, Attribute Sciences, Process Development, Amgen, Inc.
  • Panelist Shawn Novick - Sr. Director Quality Control, Seattle Genetics, Inc.
  • Panelist Denise Kingsbury, M.S. - Associate Scientist, MedImmune
more
2:00pm - 2:30pm 30 mins
Biological Assays: Method Bridging and Method Tech Transfer for Bioassays
Short Oral Poster Presentations
  • Richard Somberg, Ph.D. - Strategic Collaborations Manager, Promega Corporation
  • Alla Zilberman, Ph.D. - Technical Marketing Manager, Cygnus Technologies, LLC
  • Mike Bogan, Ph.D. - Director of Development, IonDx
more

2:00-2:10 Quantitative Cell-Based Bioassays to Advance Immunotherapy Programs Targeting Immune Checkpoint Receptors

Richard Somberg, Strategic Collaborations Manager, Promega Corporation

2:10-2:20 Antibody Affinity Extraction (AAE) – A Superior Alternative To 2D Western Blot

Alla Zilberman, Ph.D., Technical Marketing Manager, Cygnus Technologies, LLC

2:20-2:30 Protein Ion Mobility: A Rapid High-Throughput Direct Measure of Protein Higher Order Structure

Mike Bogan, Ph.D., Director of Development, IonDx

2:30pm - 3:00pm 30 mins
Networking and Refreshment Break in Poster and Exhibit Hall
3:00pm - 3:30pm 30 mins
Well Characterized Biologics: Biosimilar Characterization and Comparability
Structural and Functional Studies of Infliximab and ABP 710 Biosimilar
  • Renuka Sivendran, Ph.D. - Principal Scientist, Biosimilars Process Development, Amgen Inc.
more

ABP 710 is being developed as a biosimilar product to infliximab (Remicade®). Infliximab and ABP 710 are chimeric human-murine Immunoglobulin G Type 1 (IgG1) monoclonal antibodies that bind and neutralize human tumor necrosis factor alpha (TNFa). Infliximab is produced in murine hybridoma cells (Sp2/0) and ABP 710 is produced in Chinese hamster ovary (CHO) cells. Demonstrating analytical similarity is critical for the approval of a biosimilar product. Therefore, structural and functional studies of ABP 710 and infliximab were performed to demonstrate that ABP 710 is analytically similar to infliximab. Additional contributors: Ramsey Saleem, Palanisamy Kanakaraj, Cynthia Li, Shawn Cao, and Jennifer Liu.

3:00pm - 3:30pm 30 mins
Biological Assays: Potency Assays: Automation, Statistics & Critical Reagents
Accelerating Potency Bioassay Delivery by Leveraging Automation and Cellular Assay Platforms
  • John Lehrach - Research Scientist, Bristol-Myers Squibb
more

Leads Discovery & Optimization (LDO) Department within BMS has created a centralized Core Bioassay Group (CBG) to bridge drug discovery and bioassay development, as well as, transfer target knowledge to GMS collaborators. Efficient potency bioassay workflows have been developed to streamline go/no go decisions for selecting and validating the right “fit for purpose” bioassay platforms with proper MOA linkage. Multiple case-studies will be highlighted to demonstrate how CBG leveraged automation technology to accelerate key deliverables and help reduce the timeline from drug discovery to bioassay optimization, including case studies of how LDO transferred potency bioassays to QC lab for product quality testing.

3:30pm - 4:00pm 30 mins
Well Characterized Biologics: Biosimilar Characterization and Comparability
Using Stability Descriptors and Biophysical Predictors for Successful Biosimilar Formulation Development and Characterization
  • Hiten Gutka, Ph.D. - Principal Scientist, Formulation Development, Oncobiologics Inc.
more

Biosimilar formulation and drug product development presents a unique challenge whether to copy the reference product composition or to develop a rational alternate composition. The landscape of formulation and drug product development for biosimilars which includes FDA guidance, Intellectual property aspects and life cycle management will be reviewed. This presentation will discuss how DLS-couple Raman Spectroscopy (Zetasizer Helix) can be effectively utilized to characterize the degradation profile and overall stability of a biosimilar antibody formulation compared to reference product. The presentation will briefly touch on another case study wherein the liquid formulation for a biosimilar product was developed from a unique biophysical predictors derived from biophysical methods including light scattering (DLS, SLS) and thermal methods (DSC). The developed alternative formulation was tested and compared to reference product for stability descriptors, namely subvisible and submicron particle profile and viscosity. In summary both case studies will highlight how formulation development, characterization and stability assessment for biosimilars can be achieved by use of orthogonal biophysical characterization tools.

3:30pm - 4:00pm 30 mins
Biological Assays: Potency Assays: Automation, Statistics & Critical Reagents
Strategies for Critical Reagent Management for Potency Assays
  • Vineetha Jayasena, Ph.D. - Principal Scientist, Global Cellular & Analytical Resources, Amgen
more

Critical reagents are key components that directly affect potency method performance. These include reagents such as cell lines, serum, and recombinant proteins.  Each of these may be prone to lot-to-lot variability, which can impact method performance. Thus, a well-defined critical reagent management strategy is needed to ensure thorough characterization. This presentation summarizes key considerations for the generation, characterization, qualification, stability assessment, and life cycle management of critical reagents.

4:00pm - 4:30pm 30 mins
Well Characterized Biologics: Biosimilar Characterization and Comparability
New Techniques for Characterization of Glycoprotein Drug Products
  • Parastoo Azadi, Ph.D. - Technical Director, Complex Carbohydrate Research Center, University of Georgia
more

We have developed a platform for the analysis of glycoproteins by integrating glycomics and glycoproteomics in a single one-pot experiment through the permethylation of glycopeptides and their tandem mass spectrometry analysis. The proposed methodology has the potential to accelerate glycoproteomics research and to make it accessible to the pharmaceutical industry.

4:00pm - 4:05pm 5 mins
Biological Assays: Potency Assays: Automation, Statistics & Critical Reagents
Close of Biological Assays Track
4:30pm - 4:35pm 5 mins
Close of Conference – See you in 2018!